Trial Outcomes & Findings for The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study (NCT NCT02979587)

Results Overview

The primary safety endpoint is point estimate of freedom from procedure or device-related mortality rate at 30 days post procedure.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

86 participants

Primary outcome timeframe

30 days

Results posted on

2025-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Implanted Pivotal Harmony TPV Subjects This study is comprised of a single arm of subjects implanted with the Harmony TPV device during the pivotal study.
Overall Study STARTED	50
Overall Study Catheterized	50
Overall Study Implanted	50
Overall Study Implanted > 24 Hours	48
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Implanted Pivotal Harmony TPV Subjects n=50 Participants This study is comprised of a single arm of subjects implanted with the Harmony TPV device during the pivotal study.
Age, Continuous	28.7 years STANDARD_DEVIATION 11.3 • n=99 Participants
Sex: Female, Male Female	19 Participants n=99 Participants
Sex: Female, Male Male	31 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	6 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	40 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=99 Participants
Region of Enrollment United States	48 participants n=99 Participants
Region of Enrollment Japan	2 participants n=99 Participants

PRIMARY outcome

Timeframe: 30 days

Population: The catheterized cohort consists of all subjects who undergo catheterization for possible implantation of the Harmony TPV. The primary safety endpoint population includes all subjects that were catheterized and also had evaluable data at 30 days. Two subjects were exited prior to the 30 day timepoint.

The primary safety endpoint is point estimate of freedom from procedure or device-related mortality rate at 30 days post procedure.

Outcome measures

Outcome measures
Measure	Catheterized Cohort n=48 Participants Subjects included in this analysis were those who were catheterized for a Harmony TPV implant and had evaluable data at 30 days.
Freedom From Procedure- or Device-related Mortality at 30 Days.	48 Participants

PRIMARY outcome

Timeframe: 6 months

Population: The implanted \>24 hours cohort consists of all subjects who have a Harmony TPV implanted which remains implanted for greater than 24 hours.

Defined as: * Mean RVOT gradient as measured by continuous-wave Doppler ≤40 mmHg -AND- * Pulmonary regurgitant fraction as measured by magnetic resonance imaging \<20%

Outcome measures

Outcome measures
Measure	Catheterized Cohort n=48 Participants Subjects included in this analysis were those who were catheterized for a Harmony TPV implant and had evaluable data at 30 days.
Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months	43 Participants

SECONDARY outcome

Timeframe: At exit from catheterization lab/operating room (OR)

Population: The attempted implant cohort consists of all subjects who undergo catheterization and a Harmony TPV implantation was attempted (Harmony TPV is introduced into the subject's body).

Technical success at exit from catheterization lab/operating room (OR), as defined as: * No device- or procedural-related mortality, with * Successful access, delivery and retrieval of the delivery system, and * Deployment and correct positioning (including minor repositioning if needed) of the single intended device, and * No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure

Outcome measures

Outcome measures
Measure	Catheterized Cohort n=50 Participants Subjects included in this analysis were those who were catheterized for a Harmony TPV implant and had evaluable data at 30 days.
Number of Participants With Technical Success at Exit From Catheterization Lab/Operating Room (OR)	45 Participants

SECONDARY outcome

Timeframe: 5 years

Device success is defined as: * No device- or procedural-related mortality, with * Original intended device in place, and * No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the catheterization lab), and * Intended performance of the device, as defined as: * Structural performance: No migration, embolization, detachment, major stent fracture, hemolysis, thrombosis, endocarditis, and * Hemodynamic performance: Relief of insufficiency (PR \< moderate) without producing the opposite (mean RVOT gradient \> 40 mmHg) as measured by continuous wave Doppler, and * Absence of para-device complications, as defined by: * PVL = moderate, or * Erosion, or * RVOT or PA rupture

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Population: The attempted implant cohort consists of all subjects who undergo catheterization and a Harmony TPV implantation was attempted (Harmony TPV is introduced into the subject's body).

Procedural success is defined as: * Device success at 30 days, and * None of the following device- or procedure-related serious adverse events: * Life-threatening major bleed * Major vascular or cardiac structural complications required unplanned reintervention or surgery * Stage 2 or 3 acute kidney injury (AKI) (includes new dialysis) * Pulmonary embolism * Severe heart failure (HF) or hypotension requiring IV inotrope, ultrafiltration, or mechanical circulatory support * Prolonged intubation \>48 hours

Outcome measures

Outcome measures
Measure	Catheterized Cohort n=50 Participants Subjects included in this analysis were those who were catheterized for a Harmony TPV implant and had evaluable data at 30 days.
Number of Participants With Procedural Success at 30 Days	42 Participants

SECONDARY outcome

Timeframe: 5 years (5 year data has an anticipated reporting date of April 2026)

TPV dysfunction is defined as any one of the following: * RVOT reoperation for device-related reasons * Catheter re-intervention of TPV * Hemodynamic dysfunction of the TPV (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient \>40 mmHg)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Ongoing

All procedure-related serious adverse events. All device-related serious adverse events. Death (all-cause, procedural, and device-related).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 30 Day, 6 Month, 1 Year, 2 Year, 3 Year

Population: Number analyzed differs from overall number analyzed because subjects have either exited or have not yet completed that timepoint.

Quality of life score over time will be assessed by the SF-36 at pre-implant, 1 month post-implant, 6 months post-implant, 1 year post-implant, 2 years post-implant, and 3 years. The analysis cohort will be the implanted \> 24 hours cohort. Minimum score of 0 and maximum score of 100 is possible. Higher values are considered to be a better outcome.

Outcome measures

Outcome measures
Measure	Catheterized Cohort n=48 Participants Subjects included in this analysis were those who were catheterized for a Harmony TPV implant and had evaluable data at 30 days.
Characterization of Quality of Life Scores Out to 5 Years Baseline	80.5 score on a scale Standard Deviation 25.6
Characterization of Quality of Life Scores Out to 5 Years 30 Day Follow-up	90.2 score on a scale Standard Deviation 15.6
Characterization of Quality of Life Scores Out to 5 Years 6 Month Follow-up	94.6 score on a scale Standard Deviation 8.8
Characterization of Quality of Life Scores Out to 5 Years 1 Year Follow-up	91.6 score on a scale Standard Deviation 14.9
Characterization of Quality of Life Scores Out to 5 Years 2 Year Follow-up	94.4 score on a scale Standard Deviation 11.0
Characterization of Quality of Life Scores Out to 5 Years 3 Year Follow-up	98.3 score on a scale Standard Deviation 4.1

SECONDARY outcome

Timeframe: Baseline, 6 Month

Population: Subjects included in this analysis were those who were successfully implanted with a Harmony TPV for greater than 24 hours and had evaluable CMR data at the given timepoint.

Right ventricle remodeling will be assessed via CMR at pre-implant and 6 months post-implant. The analysis cohort will be implanted longer than 24 hours cohort. The characterization will be made using right ventricular end diastolic volume (ml).

Outcome measures

Outcome measures
Measure	Catheterized Cohort n=26 Participants Subjects included in this analysis were those who were catheterized for a Harmony TPV implant and had evaluable data at 30 days.
Characterization of Right Ventricle Remodeling Following TPV Implant Pre-implant	291.5 ml Standard Deviation 57.4
Characterization of Right Ventricle Remodeling Following TPV Implant 6 Months	223.0 ml Standard Deviation 54.9

SECONDARY outcome

Timeframe: 4 Year, 5 Year (4 & 5 year data has an anticipated reporting date of April 2026)

Quality of life score over time will be assessed by the SF-36 at 4 \& 5 years. The analysis cohort will be the implanted \> 24 hours cohort. Minimum score of 0 and maximum score of 100 is possible. Higher values are considered to be a better outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 Year, 5 Year (2 & 5 year data has an anticipated reporting date of April 2026)

Right ventricle remodeling will be assessed via CMR at 2 years post- implant and 5 years post-implant. The analysis cohort will be implanted longer than 24 hours cohort. The characterization will be made using right ventricular end diastolic volume (ml).

Outcome measures

Outcome data not reported

Adverse Events

Catheterized Cohort

Serious events: 3 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Catheterized Cohort n=50 participants at risk The catheterized cohort consists of all subjects who undergo catheterization for possible implantation of the Harmony TPV.
Cardiac disorders Complete Heart Block	2.0% 1/50 • Number of events 1 • Adverse Event data are collected through study completion, an average of 5 years Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Cardiac disorders Ventricular Tachycardia	2.0% 1/50 • Number of events 1 • Adverse Event data are collected through study completion, an average of 5 years Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
General disorders Device Dislocation	2.0% 1/50 • Number of events 1 • Adverse Event data are collected through study completion, an average of 5 years Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.

Other adverse events

Other adverse events
Measure	Catheterized Cohort n=50 participants at risk The catheterized cohort consists of all subjects who undergo catheterization for possible implantation of the Harmony TPV.
Cardiac disorders Arrhythmia	8.0% 4/50 • Number of events 4 • Adverse Event data are collected through study completion, an average of 5 years Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Cardiac disorders Palpitations	6.0% 3/50 • Number of events 3 • Adverse Event data are collected through study completion, an average of 5 years Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Cardiac disorders Premature Ventricular Ectopic Beats	12.0% 6/50 • Number of events 6 • Adverse Event data are collected through study completion, an average of 5 years Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Cardiac disorders Supraventricular Tachycardia	6.0% 3/50 • Number of events 3 • Adverse Event data are collected through study completion, an average of 5 years Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Cardiac disorders Tricuspid Regurgitation	6.0% 3/50 • Number of events 3 • Adverse Event data are collected through study completion, an average of 5 years Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Cardiac disorders Ventricular Tachycardia	14.0% 7/50 • Number of events 7 • Adverse Event data are collected through study completion, an average of 5 years Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Gastrointestinal disorders Vomiting	6.0% 3/50 • Number of events 3 • Adverse Event data are collected through study completion, an average of 5 years Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
General disorders Chest Pain	12.0% 6/50 • Number of events 6 • Adverse Event data are collected through study completion, an average of 5 years Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
General disorders Fever	20.0% 10/50 • Number of events 13 • Adverse Event data are collected through study completion, an average of 5 years Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Injury, poisoning and procedural complications Radiation Burn	6.0% 3/50 • Number of events 4 • Adverse Event data are collected through study completion, an average of 5 years Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Product Issues Device Shape Alteration	6.0% 3/50 • Number of events 3 • Adverse Event data are collected through study completion, an average of 5 years Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Product Issues Paravalvular Leak	10.0% 5/50 • Number of events 5 • Adverse Event data are collected through study completion, an average of 5 years Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Vascular disorders Hemorrhage	10.0% 5/50 • Number of events 6 • Adverse Event data are collected through study completion, an average of 5 years Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.

Additional Information

Lindsey Gustafson, Clinical Study Manager

Medtronic

Phone: 7635262782

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60