Trial Outcomes & Findings for HAART 200 Aortic Valve Annuloplasty Trial (NCT NCT02071849)
NCT ID: NCT02071849
Last Updated: 2017-04-17
Results Overview
COMPLETED
NA
20 participants
6 months postprocedure
2017-04-17
Participant Flow
Participant milestones
| Measure |
Aortic Valve Repair
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
6-month Primary Endpoint
STARTED
|
20
|
|
6-month Primary Endpoint
COMPLETED
|
15
|
|
6-month Primary Endpoint
NOT COMPLETED
|
5
|
|
2-year Extended Follow-up
STARTED
|
15
|
|
2-year Extended Follow-up
COMPLETED
|
14
|
|
2-year Extended Follow-up
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Aortic Valve Repair
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
6-month Primary Endpoint
Did not receive device
|
4
|
|
6-month Primary Endpoint
Adverse Event
|
1
|
|
2-year Extended Follow-up
Adverse Event
|
1
|
Baseline Characteristics
Participants with an echocardiogram evaluable for this measure.
Baseline characteristics by cohort
| Measure |
Aortic Valve Repair
n=16 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Age, Continuous
|
44.4 years
STANDARD_DEVIATION 11.3 • n=16 Participants
|
|
Age, Customized
18-29
|
3 Participants
n=16 Participants
|
|
Age, Customized
30-39
|
2 Participants
n=16 Participants
|
|
Age, Customized
40-49
|
6 Participants
n=16 Participants
|
|
Age, Customized
50-59
|
4 Participants
n=16 Participants
|
|
Age, Customized
60-69
|
1 Participants
n=16 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=16 Participants
|
|
Region of Enrollment
Germany
|
16 participants
n=16 Participants
|
|
Aortic Insufficiency
0
|
1 Participants
n=16 Participants
|
|
Aortic Insufficiency
1+
|
3 Participants
n=16 Participants
|
|
Aortic Insufficiency
2+
|
2 Participants
n=16 Participants
|
|
Aortic Insufficiency
3+
|
5 Participants
n=16 Participants
|
|
Aortic Insufficiency
4+
|
3 Participants
n=16 Participants
|
|
Aortic Insufficiency
Grade not available
|
2 Participants
n=16 Participants
|
|
New York Heart Association (NYHA) Functional Capacity
I
|
3 Participants
n=16 Participants
|
|
New York Heart Association (NYHA) Functional Capacity
II
|
13 Participants
n=16 Participants
|
|
New York Heart Association (NYHA) Functional Capacity
III
|
0 Participants
n=16 Participants
|
|
New York Heart Association (NYHA) Functional Capacity
IV
|
0 Participants
n=16 Participants
|
|
Peak gradient
|
25.5 mm Hg
STANDARD_DEVIATION 22.3 • n=13 Participants • Participants with an echocardiogram evaluable for this measure.
|
|
Mean gradient
|
13.4 mm Hg
STANDARD_DEVIATION 12.9 • n=13 Participants • Participants with an echocardiogram evaluable for this measure.
|
|
Left ventricular (LV) mass
|
288.62 g
STANDARD_DEVIATION 90.23 • n=13 Participants • Participants with an echocardiogram evaluable for this measure.
|
|
Left ventricular internal dimension (LVID) diastole
|
5.408 cm
STANDARD_DEVIATION 0.952 • n=13 Participants • Participants with an echocardiogram evaluable for this measure.
|
|
LVID systole
|
3.527 cm
STANDARD_DEVIATION 0.793 • n=11 Participants • Participants with an echocardiogram evaluable for this measure.
|
|
LV diastolic volume
|
144.5 ml
STANDARD_DEVIATION 57.6 • n=11 Participants • Participants with an echocardiogram evaluable for this measure.
|
|
LV systolic volume
|
69.1 ml
STANDARD_DEVIATION 36.6 • n=11 Participants • Participants with an echocardiogram evaluable for this measure.
|
|
Left ventricular ejection fraction (LVEF)
|
53.86 percentage of blood volume
STANDARD_DEVIATION 8.76 • n=11 Participants • Participants with an echocardiogram evaluable for this measure.
|
|
Cardiac output
|
7.926 l/min
STANDARD_DEVIATION 2.365 • n=12 Participants • Participants with an echocardiogram evaluable for this measure.
|
|
Cardiac index
|
3.88 l/min/m^2
STANDARD_DEVIATION 1.16 • n=12 Participants • Participants with an echocardiogram evaluable for this measure.
|
PRIMARY outcome
Timeframe: 6 months postprocedureOutcome measures
| Measure |
Aortic Valve Repair
n=16 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure.
|
100 percentage of participants
Interval 79.4 to 100.0
|
PRIMARY outcome
Timeframe: 6 months postprocedurePopulation: Participants with an echocardiogram evaluable for this measure.
Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderately Severe (3+), or Severe (4+)
Outcome measures
| Measure |
Aortic Valve Repair
n=15 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months
0
|
5 Participants
|
|
Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months
1+
|
6 Participants
|
|
Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months
2+
|
4 Participants
|
|
Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months
3+
|
0 Participants
|
|
Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months
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 following the procedure: - Aortic annular dissection, rupture, or leaflet damage - 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 |
Aortic Valve Repair
n=16 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Implant Procedure Success
|
100 percentage of participants
Interval 79.4 to 100.0
|
SECONDARY outcome
Timeframe: 6 months postprocedureFreedom from specified clinical cardiovascular events 6 months 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 6 months
Outcome measures
| Measure |
Aortic Valve Repair
n=16 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Actuarial Freedom From Clinical Cardiovascular Events
|
87.5 percentage of participants
Interval 58.6 to 96.7
|
SECONDARY outcome
Timeframe: 2 years postprocedureFreedom from specified clinical cardiovascular events 6 months 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 6 months
Outcome measures
| Measure |
Aortic Valve Repair
n=16 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Actuarial Freedom From Clinical Cardiovascular Events
|
81.2 percentage of participants
Interval 52.5 to 93.5
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Aortic Valve Repair
n=16 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure.
|
100 percentage of participants
Interval 79.4 to 100.0
|
SECONDARY outcome
Timeframe: Baseline and 2 yearsPopulation: Participants with an echocardiogram evaluable for this measure.
Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
Outcome measures
| Measure |
Aortic Valve Repair
n=14 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Aortic Insufficiency (AI) at 2 Years
0
|
2 Participants
|
|
Aortic Insufficiency (AI) at 2 Years
1+
|
11 Participants
|
|
Aortic Insufficiency (AI) at 2 Years
2+
|
1 Participants
|
|
Aortic Insufficiency (AI) at 2 Years
3+
|
0 Participants
|
|
Aortic Insufficiency (AI) at 2 Years
4+
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months postprocedurePopulation: Participants with an evaluation of this measure.
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 |
Aortic Valve Repair
n=15 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
New York Heart Association (NYHA) Functional Capacity Classification
I
|
15 Participants
|
|
New York Heart Association (NYHA) Functional Capacity Classification
II
|
0 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 postprocedurePopulation: Participants with an evaluation of this measure.
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 |
Aortic Valve Repair
n=14 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
NYHA Functional Capacity Classification
I
|
14 Participants
|
|
NYHA Functional Capacity Classification
II
|
0 Participants
|
|
NYHA Functional Capacity Classification
III
|
0 Participants
|
|
NYHA Functional Capacity Classification
IV
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.
Transthoracic echocardiography parameter
Outcome measures
| Measure |
Aortic Valve Repair
n=12 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Peak Gradient - Change From Baseline
|
1.1 mm Hg
Standard Deviation 22.4
|
SECONDARY outcome
Timeframe: Baseline and 2 yearsPopulation: Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.
Transthoracic echocardiography parameter
Outcome measures
| Measure |
Aortic Valve Repair
n=11 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Peak Gradient - Change From Baseline
|
1.4 mm Hg
Standard Deviation 16.3
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.
Transthoracic echocardiography parameter
Outcome measures
| Measure |
Aortic Valve Repair
n=12 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Mean Gradient - Change From Baseline
|
1.2 mm Hg
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: Baseline and 2 yearsPopulation: Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.
Transthoracic echocardiography parameter
Outcome measures
| Measure |
Aortic Valve Repair
n=11 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Mean Gradient - Change From Baseline
|
2.4 mm Hg
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.
Left ventricular mass. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
Aortic Valve Repair
n=10 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Left Ventricular (LV) Mass - Change From Baseline
|
-53.98 g
Standard Deviation 76.21
|
SECONDARY outcome
Timeframe: Baseline and 2 yearsPopulation: Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.
Left ventricular mass. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
Aortic Valve Repair
n=10 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
LV Mass - Change From Baseline
|
-78.84 g
Standard Deviation 88.00
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
Aortic Valve Repair
n=10 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Left Ventricular Internal Dimension (LVID) Diastole - Change From Baseline
|
-0.306 cm
Standard Deviation 0.843
|
SECONDARY outcome
Timeframe: Baseline and 2 yearsPopulation: Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
Aortic Valve Repair
n=10 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
LVID Diastole - Change From Baseline
|
-0.455 cm
Standard Deviation 1.023
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
Aortic Valve Repair
n=8 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
LVID Systole - Change From Baseline
|
0.030 cm
Standard Error 0.531
|
SECONDARY outcome
Timeframe: Baseline and 2 yearsPopulation: Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
Aortic Valve Repair
n=4 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
LVID Systole - Change From Baseline
|
-0.700 cm
Standard Deviation 1.108
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.
Left ventricular diastolic volume. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
Aortic Valve Repair
n=6 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
LV Diastolic Volume - Change From Baseline
|
2.8 ml
Standard Deviation 41.3
|
SECONDARY outcome
Timeframe: Baseline and 2 yearsPopulation: Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.
Left ventricular diastolic volume. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
Aortic Valve Repair
n=7 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
LV Diastolic Volume - Change From Baseline
|
26.9 ml
Standard Deviation 40.9
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.
Left ventricular systolic volume. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
Aortic Valve Repair
n=6 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
LV Systolic Volume - Change From Baseline
|
1.3 ml
Standard Deviation 25.8
|
SECONDARY outcome
Timeframe: Baseline and 2 yearsPopulation: Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.
Left ventricular systolic volume. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
Aortic Valve Repair
n=7 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
LV Systolic Volume - Change From Baseline
|
7.9 ml
Standard Deviation 24.9
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.
Left ventricular ejection fraction. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
Aortic Valve Repair
n=6 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Left Ventricular Ejection Fraction (LVEF) - Change From Baseline
|
0.00 percentage of blood volume
Standard Deviation 8.83
|
SECONDARY outcome
Timeframe: Baseline and 2 yearsPopulation: Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.
Left ventricular ejection fraction. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
Aortic Valve Repair
n=7 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Left Ventricular Ejection Fraction (LVEF) - Change From Baseline
|
4.21 percentage of blood volume
Standard Deviation 10.02
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.
Stroke volume x heart rate. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
Aortic Valve Repair
n=9 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Cardiac Output - Change From Baseline
|
-0.932 l/min
Standard Deviation 2.979
|
SECONDARY outcome
Timeframe: Baseline and 2 yearsPopulation: Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.
Stroke volume x heart rate. Transthoracic echocardiography parameter.
Outcome measures
| Measure |
Aortic Valve Repair
n=8 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Cardiac Output - Change From Baseline
|
-2.145 l/min
Standard Deviation 2.679
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.
Hemodynamic parameter computed as cardiac output divided by body surface area
Outcome measures
| Measure |
Aortic Valve Repair
n=9 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Cardiac Index - Change From Baseline
|
-0.50 l/min/m^2
Standard Deviation 1.50
|
SECONDARY outcome
Timeframe: Baseline and 2 yearsPopulation: Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.
Hemodynamic parameter computed as cardiac output divided by body surface area
Outcome measures
| Measure |
Aortic Valve Repair
n=8 Participants
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Cardiac Index - Change From Baseline
|
-1.09 l/min/m^2
Standard Deviation 1.28
|
Adverse Events
Aortic Valve Repair
Serious adverse events
| Measure |
Aortic Valve Repair
n=16 participants at risk
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Cardiac disorders
Aortic vlave incompetence
|
18.8%
3/16 • Number of events 3 • 2 years
|
|
Cardiac disorders
Arrhythmia
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Cardiac disorders
Pericarditis
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Infections and infestations
Wound infection
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Thermal burn
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukemia
|
6.2%
1/16 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Aortic Valve Repair
n=16 participants at risk
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.8%
3/16 • Number of events 3 • 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Cardiac disorders
Aortic valve incompetence
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Cardiac disorders
Arrhythmia
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
18.8%
3/16 • Number of events 3 • 2 years
|
|
Cardiac disorders
Pericardial effusion
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Cardiac disorders
Tachycardia
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
General disorders
Impaired healing
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Infections and infestations
Infection
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Investigations
Laboratory test abnormal
|
12.5%
2/16 • Number of events 2 • 2 years
|
|
Nervous system disorders
Paraesthesia
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
2/16 • Number of events 2 • 2 years
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Vascular disorders
Aortic dilation
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Vascular disorders
Aortic stenosis
|
12.5%
2/16 • Number of events 2 • 2 years
|
|
Vascular disorders
Haemorrhage
|
12.5%
2/16 • Number of events 2 • 2 years
|
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