Trial Outcomes & Findings for Study on Safety and Performance of Medtentia Mitral Valve Repair System in Surgical Repair of Mitral Regurgitation (NCT NCT01678144)
NCT ID: NCT01678144
Last Updated: 2019-08-09
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Time from surgery through hospital discharge, up to 7 days.
Results posted on
2019-08-09
Participant Flow
All patients were enrolled at Helsinki University Central Hospital from June 2011 to April 2014. During Stage 1 (2011-2012) and Stage 2 (2013-2016) MAR was implanted for 12 patients. 11 of 24 consented patients did not receive MAR due to non-anatomical fit (majority in Stage 1); for 1 patient MAR was replaced before the operation was completed.
Patients qualifying for mitral valve repair surgery according to guidelines from the European Society of Cardiology (ESC) and the American Heart Association (AHA) and meeting pre-operative selection criteria. Successful implantation rate improved significantly during Stage 2 after sizing adjustment of the implant (Regular and Expanded).
Unit of analysis: MAR implant
Participant milestones
| Measure |
Medtentia Annuloplasty Ring (MAR)
All eligible patients underwent surgical mitral valve repair using annuloplasty device - Medtentia Annuloplasty Ring (MAR).
|
|---|---|
|
Stage 1: MAR Classic
STARTED
|
7 7
|
|
Stage 1: MAR Classic
COMPLETED
|
6 6
|
|
Stage 1: MAR Classic
NOT COMPLETED
|
1 1
|
|
Stage 2: MAR Regular and MAR Expanded
STARTED
|
5 5
|
|
Stage 2: MAR Regular and MAR Expanded
COMPLETED
|
5 5
|
|
Stage 2: MAR Regular and MAR Expanded
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
| Measure |
Medtentia Annuloplasty Ring (MAR)
All eligible patients underwent surgical mitral valve repair using annuloplasty device - Medtentia Annuloplasty Ring (MAR).
|
|---|---|
|
Stage 1: MAR Classic
Adverse Event
|
1
|
Baseline Characteristics
Assessment not available for one patient.
Baseline characteristics by cohort
| Measure |
Medtentia Annuloplasty Ring (MAR)
n=12 Participants
Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=12 Participants
|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 8.3 • n=12 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=12 Participants
|
|
Region of Enrollment
Finland
|
12 participants
n=12 Participants
|
|
New York Heart Association (NYHA) Functional Capacity
Class I
|
2 participants
n=12 Participants
|
|
New York Heart Association (NYHA) Functional Capacity
Class II
|
5 participants
n=12 Participants
|
|
New York Heart Association (NYHA) Functional Capacity
Class III
|
4 participants
n=12 Participants
|
|
New York Heart Association (NYHA) Functional Capacity
Class IV
|
1 participants
n=12 Participants
|
|
Left Ventricular Inner Dimension Systole
|
46 millimeters
n=11 Participants • Assessment not available for one patient.
|
|
Mitral valve regurgitation
Class I
|
0 participants
n=11 Participants • Assessment not available for one patient.
|
|
Mitral valve regurgitation
Class II
|
0 participants
n=11 Participants • Assessment not available for one patient.
|
|
Mitral valve regurgitation
Class III
|
0 participants
n=11 Participants • Assessment not available for one patient.
|
|
Mitral valve regurgitation
Class IV
|
11 participants
n=11 Participants • Assessment not available for one patient.
|
|
Smoking status
Current smoker
|
1 Participants
n=12 Participants
|
|
Smoking status
Non-smoker/ Former smoker
|
11 Participants
n=12 Participants
|
|
Mitral valve leaflet coaptation height
|
14 millimeters
n=11 Participants • Assessment not available for one patient.
|
|
Left Ventricular Inner Dimension Diastole
|
60 millimeters
n=11 Participants • Assessment not available for one patient.
|
PRIMARY outcome
Timeframe: Time from surgery through hospital discharge, up to 7 days.Outcome measures
| Measure |
Medtentia Annuloplasty Ring (MAR)
n=12 Participants
Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
|
|---|---|
|
Safety: All-cause Mortality Occurring in the Time From Surgery Through Hospital Discharge.
|
0 Participants
|
PRIMARY outcome
Timeframe: Time from baseline through V03 (3 months)Success will be defined as an improvement in at least 2 degrees in mitral regurgitation (MR) class as described in the ACC/AHA Guidelines for the Management of Patients with Valvular Heart Disease (Bonow, et al., 2008).
Outcome measures
| Measure |
Medtentia Annuloplasty Ring (MAR)
n=11 Participants
Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
|
|---|---|
|
Performance: Percentage of Participants With Improvement by at Least 2 Mitral Regurgitation Classes From Baseline (SC) to Three Months (V03) as Measured by Trans-thoracic Echocardiography (TTE).
|
90.91 percentage of participants
Interval 58.72 to 99.77
|
SECONDARY outcome
Timeframe: 30 days, 3 months, 6 months, 1 year, 1.5 years and 2 years after surgeryMortality rates determined both for all-cause mortality and for related deaths only. For the former, the causality status will be determined by the Investigator, and all deaths that are clearly unrelated to the device, the surgery or the underlying medical condition will be excluded from the analysis.
Outcome measures
| Measure |
Medtentia Annuloplasty Ring (MAR)
n=12 Participants
Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
|
|---|---|
|
Safety: 30-day Mortality and Mortality at 3 Months, 6 Months, 1 Year, 1.5 Years and 2 Years.
|
0 Participants
|
SECONDARY outcome
Timeframe: From surgery to end of study (2 years)MACE is defined as stroke and clinically significant myocardial infarction (MI), from surgery to end of study.
Outcome measures
| Measure |
Medtentia Annuloplasty Ring (MAR)
n=12 Participants
Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
|
|---|---|
|
Safety: The Occurrence, Frequency and Timing of Treatment-emergent Major Adverse Cardiac Events (MACEs).
|
1 Events
|
SECONDARY outcome
Timeframe: From surgery to end of study (2 years).Population: Due to the smaller than planned patient group size the descriptive statistics was used. Adverse events data is presented in Adverse Events section.
All the adverse events reported were non-device related.
Outcome measures
| Measure |
Medtentia Annuloplasty Ring (MAR)
n=12 Participants
Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
|
|---|---|
|
Safety: The Occurrence, Nature and Frequency of Treatment-emergent Adverse Events (AEs), in Particular Severe Serious Adverse Device Effects (SADEs).
|
30 Events
|
SECONDARY outcome
Timeframe: From surgery to end of study (2 years).Outcome measures
| Measure |
Medtentia Annuloplasty Ring (MAR)
n=12 Participants
Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
|
|---|---|
|
Safety: The Occurrence, Nature and Frequency of Device Deficiencies and Adverse Device Effects (ADEs).
|
0 Events
|
SECONDARY outcome
Timeframe: From surgery to end of study (2 years).Population: The study was terminated prematurely. Due to the smaller than planned patient group size no sufficient data was collected for planned analysis of this endpoint.
The occurrence, frequency and nature of abnormalities in any of the following: * physical examination * vital signs * electrocardiography (ECG) * echocardiography (ECHO) * Laboratory tests * Chest X-rays (taken only when clinically indicated)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day of surgery visit (V01).Population: The data for this outcome measure was not collected.This was a part of the echocardiography investigation protocol and therefore was not documented on electronic case report form although the surgeon in charge performed the investigation on the operation table.
Success will be defined as no or only residual mitral regurgitation (MR).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: V06 (24 months)Population: The study was terminated prematurely. Due to the smaller than planned patient group size no patient data at V04 (6 months) and V05 (12 months) was analyzed for this endpoint. The results provided are only for V06 (24 months).
Measurement analysis at 24 months after successful MAR implantation.
Outcome measures
| Measure |
Medtentia Annuloplasty Ring (MAR)
n=11 Participants
Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
|
|---|---|
|
Performance: Percentage of Participants With Improvement by at Least 2 Mitral Regurgitation Classes at Each Follow-up Visit (V04-V06) of the Improvement in MR From Screening, as Measured by Trans-thoracic Echocardiography (TTE).
|
100 percentage of participants
Interval 71.51 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From screening to end of study (up to 2 years)Population: The outcome is reported for subjects and follow up visits where data is available
Change from screening at each follow-up visit in the following MR parameters, as measured using TTE: * Left ventricular inner dimension systole and diastole assessment by trans-thoracic echocardiography (the dimension of inner edge to inner edge, perpendicular to the long axis of the left ventricle, at the level of the mitral valve leaflet tips, measured at end-systole and end-diastole) * Coaptation height
Outcome measures
| Measure |
Medtentia Annuloplasty Ring (MAR)
n=11 Participants
Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
|
|---|---|
|
Exploratory: Change in the Mitral Regurgitation (MR) Parameters, as Measured Using TTE.
Left Ventricular Inner Dimension Systole 3 months
|
40 millimeters
Interval 34.0 to 43.0
|
|
Exploratory: Change in the Mitral Regurgitation (MR) Parameters, as Measured Using TTE.
Left Ventricular Inner Dimension Systole 2 years
|
38 millimeters
Interval 36.0 to 43.0
|
|
Exploratory: Change in the Mitral Regurgitation (MR) Parameters, as Measured Using TTE.
Left Ventricular Inner Dimension Diastole 3 months
|
50 millimeters
Interval 45.0 to 56.0
|
|
Exploratory: Change in the Mitral Regurgitation (MR) Parameters, as Measured Using TTE.
Left Ventricular Inner Dimension Diastole 2 years
|
51 millimeters
Interval 49.0 to 52.0
|
|
Exploratory: Change in the Mitral Regurgitation (MR) Parameters, as Measured Using TTE.
Coaptation Height 3 months
|
6.2 millimeters
Interval 2.7 to 12.7
|
|
Exploratory: Change in the Mitral Regurgitation (MR) Parameters, as Measured Using TTE.
Coaptation Height 2 years
|
7.3 millimeters
Interval 3.6 to 11.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day of surgery visit (V01)Population: MAR rotation time assessment available for 9 patients only.
Duration of the following key stages of the annuloplasty procedure: * MAR implantation time (beginning with the measurement of the annulus size and ending with the completion of the last suture, but not including the time needed to measure leaflet thickness) * MAR rotation time * Suturing time (from start of annulus suturing until last knot) * Aortic clamp time * Cardiac arrest time
Outcome measures
| Measure |
Medtentia Annuloplasty Ring (MAR)
n=11 Participants
Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
|
|---|---|
|
Exploratory: Duration of the Key Stages of the Annuloplasty Procedure.
Aortic clamp time
|
87.2 minutes
Standard Deviation 24.5
|
|
Exploratory: Duration of the Key Stages of the Annuloplasty Procedure.
MAR implantation time
|
16.9 minutes
Standard Deviation 5.0
|
|
Exploratory: Duration of the Key Stages of the Annuloplasty Procedure.
Suturing time
|
14.6 minutes
Standard Deviation 4.1
|
|
Exploratory: Duration of the Key Stages of the Annuloplasty Procedure.
MAR rotation time
|
2.5 minutes
Standard Deviation 1.4
|
|
Exploratory: Duration of the Key Stages of the Annuloplasty Procedure.
Cardiac arrest time
|
116.2 minutes
Standard Deviation 32.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At screening and at each follow-up visit (except for discharge visit, up to 2 years).Outcome measures
| Measure |
Medtentia Annuloplasty Ring (MAR)
n=11 Participants
Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
|
|---|---|
|
Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.
3 monts · Class I
|
8 Participants
|
|
Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.
3 monts · Class II
|
3 Participants
|
|
Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.
3 monts · Class III
|
0 Participants
|
|
Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.
3 monts · Class IV
|
0 Participants
|
|
Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.
6 months · Class I
|
9 Participants
|
|
Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.
6 months · Class II
|
2 Participants
|
|
Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.
6 months · Class III
|
0 Participants
|
|
Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.
6 months · Class IV
|
0 Participants
|
|
Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.
1 year · Class I
|
10 Participants
|
|
Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.
1 year · Class II
|
1 Participants
|
|
Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.
1 year · Class III
|
0 Participants
|
|
Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.
1 year · Class IV
|
0 Participants
|
|
Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.
2 years · Class I
|
11 Participants
|
|
Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.
2 years · Class II
|
0 Participants
|
|
Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.
2 years · Class III
|
0 Participants
|
|
Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.
2 years · Class IV
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day of surgery visit (V01)Population: The leaflet measuring tool was designed to compress the leaflet between two jaws to measure the thickness. Due to soft tissue getting compressed between these two jaws the measure was not seen accurate, therefore this procedure was omitted in the study.
Outcome measures
Outcome data not reported
Adverse Events
Medtentia Annuloplasty Ring (MAR)
Serious events: 7 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Medtentia Annuloplasty Ring (MAR)
n=12 participants at risk
Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
|
|---|---|
|
Cardiac disorders
Residual mitral regurgitation leading to re-operation
|
8.3%
1/12 • Number of events 1 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
|
Cardiac disorders
Takotsubo cardiomyopathy
|
8.3%
1/12 • Number of events 1 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
|
Infections and infestations
Peritonsilitis l.dx
|
8.3%
1/12 • Number of events 1 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
|
Infections and infestations
Pneumonia
|
8.3%
1/12 • Number of events 1 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
|
Psychiatric disorders
Postoperative delirium
|
8.3%
1/12 • Number of events 1 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
|
Cardiac disorders
Atrial fibrillation worsening
|
8.3%
1/12 • Number of events 1 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
8.3%
1/12 • Number of events 1 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
|
Investigations
Increased white blood cell count
|
8.3%
1/12 • Number of events 1 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
|
Nervous system disorders
Transient ischemic attack
|
8.3%
1/12 • Number of events 1 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
|
Infections and infestations
Urinary tract infection/ urosepsis
|
8.3%
1/12 • Number of events 1 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
|
Nervous system disorders
Pre-symptomatic migraine
|
8.3%
1/12 • Number of events 1 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
2/12 • Number of events 2 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
|
Cardiac disorders
Atrial flutter
|
8.3%
1/12 • Number of events 1 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
Other adverse events
| Measure |
Medtentia Annuloplasty Ring (MAR)
n=12 participants at risk
Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
|
|---|---|
|
Cardiac disorders
Atrial fibrillation worsening
|
16.7%
2/12 • Number of events 2 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
4/12 • Number of events 5 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
|
Cardiac disorders
Atrial flutter
|
16.7%
2/12 • Number of events 2 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Number of events 1 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
|
Infections and infestations
Wound infection
|
16.7%
2/12 • Number of events 2 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma bronchiale
|
8.3%
1/12 • Number of events 1 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
|
Cardiac disorders
Ventricular tachycardia episode
|
8.3%
1/12 • Number of events 1 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
8.3%
1/12 • Number of events 1 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
|
Infections and infestations
Common cold
|
8.3%
1/12 • Number of events 1 • AEs documented from the point of surgery trough the follow-up (2 years).
Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60