Trial Outcomes & Findings for Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort (NCT NCT00740870)

Last Updated: 2024-03-26

Results Overview

To assess whether long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. This study is designed to test the null hypothesis that the true freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is less than or equal to 36% (PControl). To reject the null hypothesis means that freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is greater than 36% (PControl). The null (H0) and alternative (HA) hypotheses are written as follows:H0: PMelody ≤ PControl and HA: PMelody \> PControl. TPV dysfunction is a composite outcome defined as the following: * Hemodynamic dysfunction of the TPV * Moderate or greater pulmonary regurgitation, and/or * Mean Right Ventricular Outflow Tract (RVOT) gradient greater than 40 mmHg * RVOT reoperation for conduit dysfunction or device-related reasons * Catheter re-intervention on the TPV

Recruitment status

COMPLETED

Study phase

Target enrollment

171 participants

Primary outcome timeframe

5 years

Results posted on

2024-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	Enrolled All subjects enrolled (n=171)
Overall Study STARTED	171
Overall Study COMPLETED	150
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Enrolled All subjects enrolled (n=171)
Overall Study Not Catheterized	4
Overall Study Further testing contraindicated implant	17

Baseline Characteristics

Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enrolled Cohort n=171 Participants All subjects enrolled
Age, Continuous	21.8 years STANDARD_DEVIATION 9.8 • n=99 Participants
Sex: Female, Male Female	64 Participants n=99 Participants
Sex: Female, Male Male	107 Participants n=99 Participants
Region of Enrollment United States	171 participants n=99 Participants

PRIMARY outcome

Timeframe: 5 years

Population: The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.

Outcome measures

Outcome measures
Measure	Implanted >24 Hour Cohort n=149 Participants The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Kaplan-Meier Freedom From TPV Dysfunction	72.9 percentage of subjects Interval 64.4 to 79.6

SECONDARY outcome

Timeframe: 10 years

The outcome measure for this objective is TPV dysfunction, which is a composite outcome defined as RVOT reoperation for conduit dysfunction or device-related reasons, catheter re-intervention on the TPV, or hemodynamic dysfunction of the TPV (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient greater than 40 mmHg).

Outcome measures

Outcome measures
Measure	Implanted >24 Hour Cohort n=149 Participants The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Freedom From TPV Dysfunction at 10 Years	52.9 Percentage of subjects Interval 39.7 to 64.5

SECONDARY outcome

Timeframe: Within 24 Hours post implant

Population: The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).

Procedural success is a composite outcome defined as: * Melody TPV fixated within the desired location * Right Ventricle (RV) - Pulmonary Artery (PA) peak-to-peak gradient (measured in the catheterization lab) less than 35 mmHg post-implant * Less than mild pulmonary regurgitation by angiography post-implant * Free of explant at 24 hours post-implant

Outcome measures

Outcome measures
Measure	Implanted >24 Hour Cohort n=150 Participants The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Procedural Success	94.7 percentage of subjects

SECONDARY outcome

Timeframe: 5 years

Population: The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.

A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).

Outcome measures

Outcome measures
Measure	Implanted >24 Hour Cohort n=167 Participants The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Serious Procedural Adverse Event (AE)	12.6 Percent of subjects

SECONDARY outcome

Timeframe: 10 years

Population: The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.

Outcome measures

Outcome measures
Measure	Implanted >24 Hour Cohort n=167 Participants The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Serious Procedural Adverse Event (AE)	13.2 percentage of subjects

SECONDARY outcome

Timeframe: 5 years

Population: The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.

A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).

Outcome measures

Outcome measures
Measure	Implanted >24 Hour Cohort n=150 Participants The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Serious Device-related Adverse Event	28 Percentage of subjects

SECONDARY outcome

Timeframe: 10 years

Population: The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.

Outcome measures

Outcome measures
Measure	Implanted >24 Hour Cohort n=150 Participants The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Serious Device-related Adverse Event	41.3 percentage of subjects

SECONDARY outcome

Timeframe: 5 years

Population: The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.

Major stent fracture is defined as a stent fracture requiring intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

Outcome measures

Outcome measures
Measure	Implanted >24 Hour Cohort n=149 Participants The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Kaplan-Meier Freedom From Major Stent Fracture at 5 Years	84.3 percentage of subjects Interval 72.8 to 91.2

SECONDARY outcome

Timeframe: 10 years

Population: The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.

Major stent fracture is defined as a stent fracture requiring intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

Outcome measures

Outcome measures
Measure	Implanted >24 Hour Cohort n=149 Participants The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Kaplan-Meier Freedom From Major Stent Fracture at 10 Years	83.7 percentage of subjects Interval 69.8 to 91.6

SECONDARY outcome

Timeframe: 5 years

Population: The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.

Catheter Re-intervention is defined as: any catheter-based intervention involving the TPV, including balloon dilatation, stenting, or placement of a second TPV

Outcome measures

Outcome measures
Measure	Implanted >24 Hour Cohort n=149 Participants The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Kaplan-Meier Freedom From Catheter Re-intervention on TPV	81 percentage of subjects Interval 72.9 to 86.9

SECONDARY outcome

Timeframe: 10 years

Population: The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.

Catheter Re-intervention is defined as: any catheter-based intervention involving the TPV, including balloon dilatation, stenting, or placement of a second TPV

Outcome measures

Outcome measures
Measure	Implanted >24 Hour Cohort n=149 Participants The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Kaplan-Meier Freedom From Catheter Re-intervention on TPV	73.1 percentage of subjects Interval 58.4 to 83.3

SECONDARY outcome

Timeframe: 5 years

Population: The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.

Surgical Replacement of the RVOT Conduit is defined as any surgical procedure to repair, alter, or explant the TPV

Outcome measures

Outcome measures
Measure	Implanted >24 Hour Cohort n=149 Participants The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit	92.2 percentage of subjects Interval 86.2 to 95.7

SECONDARY outcome

Timeframe: 10 years

Population: The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.

Surgical Replacement of the RVOT Conduit is defined as any surgical procedure to repair, alter, or explant the TPV

Outcome measures

Outcome measures
Measure	Implanted >24 Hour Cohort n=149 Participants The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit	78.9 percentage of subjects Interval 66.5 to 87.1

SECONDARY outcome

Timeframe: 5 years

Deaths is defined as all-cause, procedural and device-related events at 5 years

Outcome measures

Outcome measures
Measure	Implanted >24 Hour Cohort n=167 Participants The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related)	96.5 percentage of subjects Interval 91.4 to 98.6

SECONDARY outcome

Timeframe: 10 years

Population: The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.

Deaths is defined as all-cause, procedural and device-related events at 10 years

Outcome measures

Outcome measures
Measure	Implanted >24 Hour Cohort n=167 Participants The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related)	90.2 percentage of subjects Interval 78.5 to 95.7

SECONDARY outcome

Timeframe: 6 Months

Population: The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours and had paired data from pre-implant to 6 months post-implant.

Improvement in Functional Assessment (NYHA Classification) at 6 months post implant.

Outcome measures

Outcome measures
Measure	Implanted >24 Hour Cohort n=143 Participants The Implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Functional Assessment (NYHA Classification) Improved	102 Participants
Functional Assessment (NYHA Classification) No Change	39 Participants
Functional Assessment (NYHA Classification) Worsened	1 Participants
Functional Assessment (NYHA Classification) Died	1 Participants

Adverse Events

Catheterized Cohort

Serious events: 106 serious events

Other events: 112 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Catheterized Cohort n=167 participants at risk The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
Blood and lymphatic system disorders Thrombocytopenia	0.60% 1/167 • Number of events 1 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Aortic Regurgitation	1.8% 3/167 • Number of events 3 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Arrhythmia	1.2% 2/167 • Number of events 2 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Atrial Fibrillation	1.2% 2/167 • Number of events 2 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Atrial Flutter	5.4% 9/167 • Number of events 13 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Cardiac Arrest	2.4% 4/167 • Number of events 4 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Cardiac Disorder	6.6% 11/167 • Number of events 13 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Cardiac Tamponade	0.60% 1/167 • Number of events 1 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Complete Heart Block	1.8% 3/167 • Number of events 3 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Congestive Heart Failure	2.4% 4/167 • Number of events 7 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Intracardiac Mass	0.60% 1/167 • Number of events 2 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Premature Ventricular Ectopic Beats	1.2% 2/167 • Number of events 2 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Pulmonary Valve Disease	1.2% 2/167 • Number of events 2 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Pulmonary Valve Regurgitation	1.8% 3/167 • Number of events 3 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Pulmonary Valve Stenosis	19.8% 33/167 • Number of events 56 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Supraventricular Tachycardia	0.60% 1/167 • Number of events 1 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Tricuspid Regurgitation	3.0% 5/167 • Number of events 8 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Ventricular Fibrillation	1.2% 2/167 • Number of events 3 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Ventricular Tachycardia	6.0% 10/167 • Number of events 12 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Gastrointestinal disorders Gastrointestinal Disorder	2.4% 4/167 • Number of events 5 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
General disorders Other Events	9.0% 15/167 • Number of events 23 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
General disorders Chest Pain	1.8% 3/167 • Number of events 4 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
General disorders Device Complication	6.0% 10/167 • Number of events 10 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
General disorders Device Rupture	1.8% 3/167 • Number of events 3 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
General disorders Fever	1.2% 2/167 • Number of events 2 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
General disorders Multi Organ Failure	1.2% 2/167 • Number of events 2 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
General disorders Prosthetic Cardiac Valve Malfunction	0.60% 1/167 • Number of events 1 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
General disorders Prosthetic Tissue Defect	0.60% 1/167 • Number of events 1 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
General disorders Stent Strut Fracture	13.8% 23/167 • Number of events 28 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Infections and infestations Endocarditis	6.6% 11/167 • Number of events 18 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Infections and infestations Infection	4.8% 8/167 • Number of events 11 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Infections and infestations Pneumonia	1.2% 2/167 • Number of events 2 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Infections and infestations Prosthetic Valve Endocarditis	10.8% 18/167 • Number of events 33 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Infections and infestations Sepsis	5.4% 9/167 • Number of events 9 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Infections and infestations Urinary Tract Infection	1.2% 2/167 • Number of events 2 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Injury, poisoning and procedural complications Procedural Complication	1.2% 2/167 • Number of events 2 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Injury, poisoning and procedural complications Procedural Hemorrhage	0.60% 1/167 • Number of events 1 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Injury, poisoning and procedural complications Procedural Hypotension	0.60% 1/167 • Number of events 2 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Injury, poisoning and procedural complications Vascular Access Complication	0.60% 1/167 • Number of events 1 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Injury, poisoning and procedural complications Prosthetic Cardiac Valve Thrombosis	0.60% 1/167 • Number of events 1 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Nervous system disorders Central Nervous System Disorder	2.4% 4/167 • Number of events 4 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Nervous system disorders Cva	0.60% 1/167 • Number of events 1 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Nervous system disorders Headache	0.60% 1/167 • Number of events 1 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Nervous system disorders Syncope	2.4% 4/167 • Number of events 5 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Renal and urinary disorders Acute Renal Failure	1.8% 3/167 • Number of events 3 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Renal and urinary disorders Renal Disorder	0.60% 1/167 • Number of events 2 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Renal and urinary disorders Renal Insufficiency	0.60% 1/167 • Number of events 1 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Respiratory, thoracic and mediastinal disorders Asthma	0.60% 1/167 • Number of events 1 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Respiratory, thoracic and mediastinal disorders Hemothorax	1.2% 2/167 • Number of events 2 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.2% 2/167 • Number of events 2 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Respiratory, thoracic and mediastinal disorders Pulmonary Thromboembolism	1.2% 2/167 • Number of events 2 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Respiratory, thoracic and mediastinal disorders Respiratory Disorder	4.2% 7/167 • Number of events 8 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.60% 1/167 • Number of events 1 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Respiratory, thoracic and mediastinal disorders Respiratory Insufficiency	0.60% 1/167 • Number of events 1 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Skin and subcutaneous tissue disorders Rash	0.60% 1/167 • Number of events 1 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Vascular disorders Embolism	0.60% 1/167 • Number of events 1 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Vascular disorders Hemorrhage	0.60% 1/167 • Number of events 1 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Vascular disorders Vascular Dissection	0.60% 1/167 • Number of events 1 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Vascular disorders Venous Thrombosis	0.60% 1/167 • Number of events 2 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Vascular disorders Vessel Perforation	1.2% 2/167 • Number of events 2 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.

Other adverse events

Other adverse events
Measure	Catheterized Cohort n=167 participants at risk The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
Blood and lymphatic system disorders Hemolysis	5.4% 9/167 • Number of events 15 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Arrhythmia	6.0% 10/167 • Number of events 12 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Cardiac Disorder	9.6% 16/167 • Number of events 18 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Palpitations	9.6% 16/167 • Number of events 23 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Cardiac disorders Tricuspid Regurgitation	7.2% 12/167 • Number of events 14 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Gastrointestinal disorders Gastrointestinal Disorder	5.4% 9/167 • Number of events 9 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
General disorders Other Events	21.0% 35/167 • Number of events 69 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
General disorders Chest Pain	10.2% 17/167 • Number of events 25 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
General disorders Stent Strut Fracture	30.5% 51/167 • Number of events 73 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Infections and infestations Infection	5.4% 9/167 • Number of events 15 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Nervous system disorders Central Nervous System Disorder	5.4% 9/167 • Number of events 10 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Nervous system disorders Headache	6.6% 11/167 • Number of events 16 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Renal and urinary disorders Renal Disorder	8.4% 14/167 • Number of events 29 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Respiratory, thoracic and mediastinal disorders Respiratory Disorder	9.6% 16/167 • Number of events 21 • Adverse event data were collected from the time of consent through end of participation in the study. Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.

Additional Information

Karla Mezera

Medtronic

Phone: 612-306-4325

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60