Trial Outcomes & Findings for HAART Model 300 Annuloplasty Ring (NCT NCT01400841)
NCT ID: NCT01400841
Last Updated: 2017-01-13
Results Overview
Event-free survival is defined as survival free from device-related death
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
1 month postprocedure
Results posted on
2017-01-13
Participant Flow
Participant milestones
| Measure |
HAART 300 Annuloplasty Device
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Initial Study Phase (6 Months)
STARTED
|
16
|
|
Initial Study Phase (6 Months)
COMPLETED
|
15
|
|
Initial Study Phase (6 Months)
NOT COMPLETED
|
1
|
|
Extended Study Phase (2 Years)
STARTED
|
13
|
|
Extended Study Phase (2 Years)
COMPLETED
|
11
|
|
Extended Study Phase (2 Years)
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
HAART 300 Annuloplasty Device
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Initial Study Phase (6 Months)
Death
|
1
|
|
Extended Study Phase (2 Years)
Adverse Event
|
2
|
Baseline Characteristics
HAART Model 300 Annuloplasty Ring
Baseline characteristics by cohort
| Measure |
HAART 300 Annuloplasty Device
n=16 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
68.1 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Gender
Female
|
3 Participants
n=5 Participants
|
|
Gender
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
13 participants
n=5 Participants
|
|
Aortic Valvular Regurgitation
0
|
0 participants
n=5 Participants
|
|
Aortic Valvular Regurgitation
1+
|
0 participants
n=5 Participants
|
|
Aortic Valvular Regurgitation
2+
|
6 participants
n=5 Participants
|
|
Aortic Valvular Regurgitation
3+
|
7 participants
n=5 Participants
|
|
Aortic Valvular Regurgitation
4+
|
3 participants
n=5 Participants
|
|
NYHA Classification
I
|
0 participants
n=5 Participants
|
|
NYHA Classification
II
|
10 participants
n=5 Participants
|
|
NYHA Classification
III
|
6 participants
n=5 Participants
|
|
NYHA Classification
IV
|
0 participants
n=5 Participants
|
|
Peak gradient
|
13.3 mm Hg
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Mean gradient
|
6.8 mm Hg
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
Left ventricular (LV) mass
|
260.0 g
STANDARD_DEVIATION 57.1 • n=5 Participants
|
|
Left ventricular internal dimension (LVID) diastole
|
5.44 cm
STANDARD_DEVIATION 0.60 • n=5 Participants
|
|
LVID systole
|
4.09 cm
STANDARD_DEVIATION 0.76 • n=5 Participants
|
|
LV diastolic volume
|
180.7 ml
STANDARD_DEVIATION 50.2 • n=5 Participants
|
|
LV systolic volume
|
84.7 ml
STANDARD_DEVIATION 25.4 • n=5 Participants
|
|
Left ventricular ejection fraction (LVEF)
|
53.2 %
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Cardiac output
|
6.77 l/min
STANDARD_DEVIATION 1.60 • n=5 Participants
|
|
Cardiac index
|
3.41 l/min/m^2
STANDARD_DEVIATION 0.90 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month postprocedureEvent-free survival is defined as survival free from device-related death
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=16 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Primary Safety Outcome Measure: Event-free Survival
|
100 percentage of participants
Interval 79.4 to 100.0
|
PRIMARY outcome
Timeframe: 2 years postprocedure (extended follow-up)Population: Extended follow-up participants
Event-free survival is defined as survival free from device-related death
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=13 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Primary Safety Outcome Measure: Event-free Survival
|
100 percentage of participants
Interval 75.3 to 100.0
|
PRIMARY outcome
Timeframe: 6 months postprocedureAortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=15 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure
0
|
2 participants
|
|
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure
1+
|
9 participants
|
|
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure
2+
|
3 participants
|
|
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure
3+
|
1 participants
|
|
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure
4+
|
0 participants
|
PRIMARY outcome
Timeframe: 2 years postprocedure (extended follow-up)Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=11 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure
0
|
2 participants
|
|
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure
1+
|
7 participants
|
|
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure
2+
|
2 participants
|
|
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure
3+
|
0 participants
|
|
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure
4+
|
0 participants
|
SECONDARY outcome
Timeframe: discharge or 14 days postprocedure, whichever comes firstSuccess is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure: * Aortic annular dissection, rupture, or leaflet damage * Paravalvular leak \> +2 or requiring intervention * Mitral valve impingement due to implant * implant dehiscence/migration into aorta * implant dehiscence/migration into left ventricle * Hemodynamics requiring intervention * Other adverse event resulting in reoperation, explantation, or permanent disability.
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=16 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Implant Procedure Success
|
100 percentage of implant procedures
Interval 79.4 to 100.0
|
SECONDARY outcome
Timeframe: 2 years postprocedure (extended follow-up)Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure: * Aortic annular dissection, rupture, or leaflet damage * Paravalvular leak \> +2 or requiring intervention * Mitral valve impingement due to implant * implant dehiscence/migration into aorta * implant dehiscence/migration into left ventricle * Hemodynamics requiring intervention * Other adverse event resulting in reoperation, explantation, or permanent disability.
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=16 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Implant Procedure Success
|
87.5 percentage of implant procedures
Interval 61.6 to 98.4
|
SECONDARY outcome
Timeframe: 1 month postprocedureFreedom from specified clinical cardiovascular events 1 month postprocedure: * Device-related mortality * Complete heart block * Structural device failure * Endocarditis * Periprosthetic leak or dehiscence * Thromboembolism * Bleeding Event * Native Valve Deterioration * Valve Thrombosis * Hemolysis * Reoperation and explant at 1 month
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=16 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Actuarial Freedom From Clinical Cardiovascular Events
|
100 percentage of implant procedures
Interval 79.4 to 100.0
|
SECONDARY outcome
Timeframe: 2 years postprocedureFreedom from specified clinical cardiovascular events 2 years postprocedure: * Device-related mortality * Complete heart block * Structural device failure * Endocarditis * Periprosthetic leak or dehiscence * Thromboembolism * Bleeding Event * Native Valve Deterioration * Valve Thrombosis * Hemolysis * Reoperation and explant at 2 years
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=16 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Actuarial Freedom From Clinical Cardiovascular Events
|
81.5 percentage of implant procedures
Interval 53.4 to 100.0
|
SECONDARY outcome
Timeframe: 6 months postprocedureEvent-free survival is defined as survival free from device-related death
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=16 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Event-free Survival
|
100 percentage of participants
Interval 79.4 to 100.0
|
SECONDARY outcome
Timeframe: 6 months postprocedurePopulation: NYHA evaluation not done on 1 of 15 participants
Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=14 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
New York Heart Association (NYHA) Functional Capacity Classification
I
|
11 participants
|
|
New York Heart Association (NYHA) Functional Capacity Classification
II
|
3 participants
|
|
New York Heart Association (NYHA) Functional Capacity Classification
III
|
0 participants
|
|
New York Heart Association (NYHA) Functional Capacity Classification
IV
|
0 participants
|
SECONDARY outcome
Timeframe: 2 years postprocedure (extended follow-up)Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=11 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
New York Heart Association (NYHA) Functional Capacity Classification
I
|
8 participants
|
|
New York Heart Association (NYHA) Functional Capacity Classification
II
|
3 participants
|
|
New York Heart Association (NYHA) Functional Capacity Classification
III
|
0 participants
|
|
New York Heart Association (NYHA) Functional Capacity Classification
IV
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months postprocedurePopulation: Baseline measure not available for 1 of 15 participants.
Transthoracic echocardiography parameter
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=14 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Peak Gradient - Change From Baseline
|
4.9 mm Hg
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: Baseline, 2 years postprocedure (extended follow-up)Population: Baseline measure not available for 1 of 11 participants.
Transthoracic echocardiography parameter
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=10 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Peak Gradient - Change From Baseline
|
10.1 mm Hg
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Baseline, 6 months postprocedurePopulation: Baseline measure not available for 1 of 15 participants.
Transthoracic echocardiography parameter
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=14 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Mean Gradient - Change From Baseline
|
2.6 mm Hg
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Baseline, 2 years postprocedure (extended follow-up)Population: Baseline measure not available for 1 of 11 participants.
Transthoracic echocardiography parameter
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=10 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Mean Gradient - Change From Baseline
|
4.8 mm Hg
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Baseline, 6 months postprocedurePopulation: Both baseline and 6-month measure available for 8 of 15 participants
Left ventricular mass. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=8 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
LV Mass - Change From Baseline
|
-53.4 g
Standard Deviation 57.1
|
SECONDARY outcome
Timeframe: Baseline, 2 years postprocedure (extended follow-up)Population: Both baseline and 2-year measure available for 6 of 11 participants.
Left ventricular mass. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=6 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
LV Mass - Change From Baseline
|
-23.3 g
Standard Deviation 72.0
|
SECONDARY outcome
Timeframe: Baseline, 6 months postprocedurePopulation: Both baseline and 6-month measure available for 8 of 15 participants.
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=8 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
LVID Diastole - Change From Baseline
|
-0.52 cm
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: Baseline, 2 years postprocedure (extended follow-up)Population: Both baseline and 2-year measure available for 7 of 11 participants.
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=7 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
LVID Diastole - Change From Baseline
|
-0.33 cm
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Baseline, 6 months postprocedurePopulation: Both baseline and 6-month measure available for 5 of 15 participants.
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=5 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
LVID Systole - Change From Baseline
|
-0.75 cm
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: Baseline, 2 years postprocedure (extended follow-up)Population: Both baseline and 2-year measure available for 3 of 11 participants.
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=3 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
LVID Systole - Change From Baseline
|
0.03 cm
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: Baseline, 6 months postprocedurePopulation: Both baseline and 6-month measure available for 7 of 15 participants.
Left ventricular diastolic volume. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=7 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
LV Diastolic Volume - Change From Baseline
|
-49.9 ml
Standard Deviation 64.2
|
SECONDARY outcome
Timeframe: Baseline, 2 years postprocedure (extended follow-up)Population: Both baseline and 2-year measure available for 5 of 11 participants.
Left ventricular diastolic volume. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=5 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
LV Diastolic Volume - Change From Baseline
|
-75.4 ml
Standard Deviation 74.3
|
SECONDARY outcome
Timeframe: Baseline, 6 months postprocedurePopulation: Both baseline and 6-month measure available for 7 of 15 participants.
Left ventricular systolic volume. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=7 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
LV Systolic Volume - Change From Baseline
|
-30.6 ml
Standard Deviation 30.2
|
SECONDARY outcome
Timeframe: Baseline, 2 years postprocedure (extended follow-up)Population: Both baseline and 2-year measure available for 5 of 11 participants.
Left ventricular systolic volume. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=5 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
LV Systolic Volume - Change From Baseline
|
-48.4 ml
Standard Deviation 38.2
|
SECONDARY outcome
Timeframe: Baseline, 6 months postprocedurePopulation: Both baseline and 6-month measure available for 7 of 15 participants.
Left ventricular ejection fraction. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=7 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
LVEF - Change From Baseline
|
5.13 percentage of blood volume
Standard Deviation 6.53
|
SECONDARY outcome
Timeframe: Baseline, 2 years postprocedure (extended follow-up)Population: Both baseline and 2-year measure available for 5 of 11 participants.
Left ventricular ejection fraction. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=5 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
LVEF - Change From Baseline
|
12.20 percentage of blood volume
Standard Deviation 9.57
|
SECONDARY outcome
Timeframe: Baseline, 6 months postprocedurePopulation: Both baseline and 6-month measure available for 7 of 15 participants.
Stroke volume x heart rate. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=7 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Cardiac Output - Change From Baseline
|
-0.73 l/min
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: Baseline, 2 years postprocedure (extended follow-up)Population: Both baseline and 2-year measure available for 5 of 11 participants.
Stroke volume x heart rate. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=5 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Cardiac Output - Change From Baseline
|
-0.36 l/min
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: Baseline, 6 months postprocedurePopulation: Both baseline and 6-month measure available for 7 of 15 participants.
Hemodynamic parameter computed as cardiac output divided by body surface area
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=7 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Cardiac Index - Change From Baseline
|
-0.40 l/min/m^2
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: Baseline, 2 years postprocedure (extended follow-up)Population: Both baseline and 2-year measure available for 5 of 11 participants.
Hemodynamic parameter computed as cardiac output divided by body surface area
Outcome measures
| Measure |
HAART 300 Annuloplasty Device
n=5 Participants
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Cardiac Index - Change From Baseline
|
-0.22 l/min/m^2
Standard Deviation 0.18
|
Adverse Events
HAART 300 Annuloplasty Device
Serious events: 8 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HAART 300 Annuloplasty Device
n=16 participants at risk
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Cardiac disorders
aortic insufficiency
|
12.5%
2/16 • Number of events 2 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Cardiac disorders
arrhythmia
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Cardiac disorders
syncope
|
12.5%
2/16 • Number of events 2 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Gastrointestinal disorders
GI bleeding
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Infections and infestations
central venous catheter infection
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Musculoskeletal and connective tissue disorders
primary coxarthrosis left
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Musculoskeletal and connective tissue disorders
radial fracture
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Nervous system disorders
choreiform movement disorder
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Nervous system disorders
postop delirium
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Renal and urinary disorders
urinary tract infection
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Respiratory, thoracic and mediastinal disorders
subcutaneous emphysema
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
Other adverse events
| Measure |
HAART 300 Annuloplasty Device
n=16 participants at risk
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair
|
|---|---|
|
Musculoskeletal and connective tissue disorders
leg pain
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Musculoskeletal and connective tissue disorders
thoracal pain
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
pulmonary mass
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Blood and lymphatic system disorders
anemia
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Blood and lymphatic system disorders
enhanced plasma free hemoglobin value
|
18.8%
3/16 • Number of events 3 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Cardiac disorders
arrhythmia
|
56.2%
9/16 • Number of events 9 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Cardiac disorders
conduction defects
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Cardiac disorders
intramural aortic hematoma
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Cardiac disorders
pericardial effusion
|
37.5%
6/16 • Number of events 6 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Injury, poisoning and procedural complications
chest pain
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Injury, poisoning and procedural complications
cicatrical hernia
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Injury, poisoning and procedural complications
reddening of wound
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Musculoskeletal and connective tissue disorders
arthrosis left knee
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Musculoskeletal and connective tissue disorders
back pain
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Musculoskeletal and connective tissue disorders
hip pain
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Nervous system disorders
flickering in the eyes
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Nervous system disorders
numbness of left little finger
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Nervous system disorders
postoperative delirium
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Nervous system disorders
symptomatic transitory psychotic syndrome
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Renal and urinary disorders
cystitis
|
12.5%
2/16 • Number of events 2 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Renal and urinary disorders
hematuria
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Respiratory, thoracic and mediastinal disorders
atelectasis
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Respiratory, thoracic and mediastinal disorders
dysphonia
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Respiratory, thoracic and mediastinal disorders
flu with fever
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Respiratory, thoracic and mediastinal disorders
mild cold
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
43.8%
7/16 • Number of events 7 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Skin and subcutaneous tissue disorders
clavus
|
6.2%
1/16 • Number of events 1 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
|
Vascular disorders
thrombophlebitis
|
12.5%
2/16 • Number of events 2 • Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication by the investigator was not allowed until completion of the trial. All proposed publications must be cleared by unanimous vote of a publication committee consisting of the sponsor and representatives of the study investigators. Publication materials must be submitted for review at least 60 day in advance of publication. The Sponsor may embargo publication for 60 additional days to allow for patent filing or may prevent publication if filling of such application would be premature.
- Publication restrictions are in place
Restriction type: OTHER