Aortic Insufficiency
Conditions
Keywords
Aortic Insufficiency (AI) Aortic Regurgitation (AR)
Brief summary
This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D intra-annular mounting frame.
Detailed description
Aortic Regurgitation, (also known as Aortic Insufficiency; AI), is the failure of the aortic valve to close completely during diastole which causes blood to flow from the aorta back into the left ventricle. Aortic Regurgitation (AR) is a frequent cause of both disability and death due to congestive heart failure, primarily in individuals forty or older, but can also occur in younger populations. Traditionally management of aortic regurgitation has been by aortic valve replacement, however, as has been observed in patients who have had mitral valve repair, the option of maintaining ones native aortic valve versus a replacement, either bioprosthetic or mechanical, can have added multiple benefits. The advantage of repair is the avoidance of prosthetic valve-related complications with bioprosthetic valves over 10-15 years or the need for anticoagulation with mechanical valves and the related problems of this therapy.
Interventions
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
Sponsors
Biostable Science & Engineering
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is 18 years of age or older * Subject has tri-leaflet aortic valve morphology * Subject has documented aortic valve disease which may or may not include: 1. aortic valve insufficiency 2. aortic root pathology 3. pathology of the ascending aorta 4. patients with associated stable one or two vessel coronary disease requiring concomitant coronary bypass * Subject is willing to comply with specified follow-up evaluations, including transesophageal echocardiography (TEE) if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve * Subject has reviewed and signed the written informed consent form * Subject agrees to return for all follow-up evaluations for the duration of the study (i.e.,. geographically stable)
Exclusion criteria
* The subject has pre-existing valve prosthesis in the aortic position * The subject's aortic valve morphology is not tri-leaflet * The subject has active endocarditis * Heavily calcified valves * The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis * Leukopenia * Acute anemia (Hb \< 9mg%) * Platelet count \<100,000 cell/mm3 * Need for emergency surgery for any reason * History of bleeding diathesis or coagulopathy or the subject refuses blood transfusions * Active infection requiring antibiotic therapy (if temporary illness, subjects may enroll 4 weeks after discontinuation of antibiotics) * Subjects in whom transesophageal echocardiography (TEE) is contraindicated * Low Ejection Fraction (EF) EF \< 35% * Life expectancy \< 1 year * The subject is or will be participating in a concomitant research study of an investigational product or has participated in such a study within the 30 days prior to screening * The subject is a minor, an illicit drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent * The subject is pregnant or lactating * Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA) * Myocardial Infarction (MI) within one month of trial inclusion * The subject has a known intolerance to titanium or polyester * The subject has documented unstable or \> 2 vessel coronary disease * The subject requires additional valve replacement or valve repair
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure | 6 months | — |
| Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months | 6 months | Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure | 2 years | — |
| Aortic Insufficiency (AI) at 2 Years | 2 years | Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+) |
| New York Heart Association (NYHA) Functional Capacity Classification at 6 Months | 6 months | 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 |
| New York Heart Association (NYHA) Functional Capacity Classification at 2 Years | 2 years | 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 |
| Peak Gradient - Change From Baseline | Baseline and 6 months | Transthoracic echocardiography parameter |
| Mean Gradient - Change From Baseline | Baseline and 6 months | Transthoracic echocardiography parameter |
| LV Mass - Change From Baseline | Baseline and 6 months | Left ventricular mass. Transthoracic echocardiography parameter. |
| Implant Procedure Success | discharge or 14 days postprocedure, whichever comes first | 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 - 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. |
| LVID Systole - Change From Baseline | Baseline and 6 months | Left ventricular internal dimension. Transthoracic echocardiography parameter. |
| LV Diastolic Volume - Change From Baseline | Baseline and 6 months | Left ventricular diastolic volume. Transthoracic echocardiography parameter. |
| LV Systolic Volume - Change From Baseline | Baseline and 6 months | Left ventricular systolic volume. Transthoracic echocardiography parameter. |
| LVEF - Change From Baseline | Baseline and 6 months | Left ventricular ejection fraction. Transthoracic echocardiography parameter. |
| Cardiac Output - Change From Baseline | Baseline and 6 months | Stroke volume x heart rate. Transthoracic echocardiography parameter. |
| Cardiac Index - Change From Baseline | Baseline and 6 months | Hemodynamic parameter computed as cardiac output divided by body surface area |
| LVID Diastole - Change From Baseline | Baseline and 6 months | Left ventricular internal dimension. Transthoracic echocardiography parameter. |
| Actuarial Freedom From Clinical Cardiovascular Events | 6 months | Freedom from specified clinical cardiovascular events at 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 |
Countries
Czechia, Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HAART 300 Annuloplasty Device Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 2-year Extended Follow-up | Adverse Event | 3 |
| 2-year Extended Follow-up | Death | 1 |
| 2-year Extended Follow-up | Withdrawal by Subject | 1 |
| 6-month Primary Endpoint | Adverse Event | 3 |
| 6-month Primary Endpoint | Did not receive device | 19 |
| 6-month Primary Endpoint | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | HAART 300 Annuloplasty Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 25 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Age, Continuous | 61.0 years STANDARD_DEVIATION 13.6 |
| Aortic Insufficiency 0 | 0 participants |
| Aortic Insufficiency 1+ | 3 participants |
| Aortic Insufficiency 2+ | 10 participants |
| Aortic Insufficiency 3+ | 18 participants |
| Aortic Insufficiency 4+ | 12 participants |
| Aortic Insufficiency Not evaluable | 6 participants |
| Cardiac index | 3.16 l/min/m^2 STANDARD_DEVIATION 1.11 |
| Cardiac output | 6.20 l/min STANDARD_DEVIATION 2.17 |
| Left ventricular ejection fraction (LVEF) | 54.2 % STANDARD_DEVIATION 4.4 |
| Left ventricular internal dimension (LVID) diastole | 5.50 cm STANDARD_DEVIATION 0.86 |
| Left ventricular (LV) mass | 244.1 g STANDARD_DEVIATION 85.2 |
| LV diastolic volume | 155.3 ml STANDARD_DEVIATION 63.3 |
| LVID systole | 4.02 cm STANDARD_DEVIATION 0.83 |
| LV systolic volume | 76.5 ml STANDARD_DEVIATION 37.7 |
| Mean gradient | 5.5 mm Hg STANDARD_DEVIATION 2.4 |
| New York Heart Association (NYHA) Functional Capacity I | 11 participants |
| New York Heart Association (NYHA) Functional Capacity II | 25 participants |
| New York Heart Association (NYHA) Functional Capacity III | 13 participants |
| New York Heart Association (NYHA) Functional Capacity IV | 0 participants |
| Peak gradient | 11.1 mm Hg STANDARD_DEVIATION 4.7 |
| Region of Enrollment Czech Republic | 5 participants |
| Region of Enrollment Germany | 44 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 38 / 49 |
| serious Total, serious adverse events | 23 / 49 |
Outcome results
Primary
Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months
Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
Time frame: 6 months
Population: Participants with an echocardiogram evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months | 0 | 11 participants |
| HAART 300 Annuloplasty Device | Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months | 1+ | 21 participants |
| HAART 300 Annuloplasty Device | Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months | 2+ | 7 participants |
| HAART 300 Annuloplasty Device | Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months | 3+ | 2 participants |
| HAART 300 Annuloplasty Device | Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months | 4+ | 0 participants |
Primary
Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HAART 300 Annuloplasty Device | Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure | 100 percentage of participants |
Secondary
Actuarial Freedom From Clinical Cardiovascular Events
Freedom from specified clinical cardiovascular events at 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
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HAART 300 Annuloplasty Device | Actuarial Freedom From Clinical Cardiovascular Events | 89.6 percentage of participants |
Secondary
Aortic Insufficiency (AI) at 2 Years
Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
Time frame: 2 years
Population: Participants with an echocardiogram evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Aortic Insufficiency (AI) at 2 Years | 0 | 2 participants |
| HAART 300 Annuloplasty Device | Aortic Insufficiency (AI) at 2 Years | 1+ | 25 participants |
| HAART 300 Annuloplasty Device | Aortic Insufficiency (AI) at 2 Years | 2+ | 10 participants |
| HAART 300 Annuloplasty Device | Aortic Insufficiency (AI) at 2 Years | 3+ | 0 participants |
| HAART 300 Annuloplasty Device | Aortic Insufficiency (AI) at 2 Years | 4+ | 0 participants |
Secondary
Cardiac Index - Change From Baseline
Hemodynamic parameter computed as cardiac output divided by body surface area
Time frame: Baseline and 2 years
Population: Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Cardiac Index - Change From Baseline | -0.26 l/min/m^2 | Standard Deviation 1.07 |
Secondary
Cardiac Index - Change From Baseline
Hemodynamic parameter computed as cardiac output divided by body surface area
Time frame: Baseline and 6 months
Population: Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Cardiac Index - Change From Baseline | -0.60 l/min/m^2 | Standard Deviation 0.85 |
Secondary
Cardiac Output - Change From Baseline
Stroke volume x heart rate. Transthoracic echocardiography parameter.
Time frame: Baseline and 6 months
Population: Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Cardiac Output - Change From Baseline | -1.15 l/min | Standard Deviation 1.66 |
Secondary
Cardiac Output - Change From Baseline
Stroke volume x heart rate. Transthoracic echocardiography parameter.
Time frame: Baseline and 2 years
Population: Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Cardiac Output - Change From Baseline | -0.50 l/min | Standard Deviation 2.2 |
Secondary
Implant Procedure Success
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 - 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.
Time frame: discharge or 14 days postprocedure, whichever comes first
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HAART 300 Annuloplasty Device | Implant Procedure Success | 95.9 percentage of implant procedures |
Secondary
LV Diastolic Volume - Change From Baseline
Left ventricular diastolic volume. Transthoracic echocardiography parameter.
Time frame: Baseline and 6 months
Population: Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LV Diastolic Volume - Change From Baseline | -21.8 ml | Standard Deviation 49.2 |
Secondary
LV Diastolic Volume - Change From Baseline
Left ventricular diastolic volume. Transthoracic echocardiography parameter.
Time frame: Baseline and 2 years
Population: Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LV Diastolic Volume - Change From Baseline | -19.9 ml | Standard Deviation 53 |
Secondary
LVEF - Change From Baseline
Left ventricular ejection fraction. Transthoracic echocardiography parameter.
Time frame: Baseline and 6 months
Population: Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LVEF - Change From Baseline | 2.49 percentage of blood volume | Standard Error 7.65 |
Secondary
LVEF - Change From Baseline
Left ventricular ejection fraction. Transthoracic echocardiography parameter.
Time frame: Baseline and 2 years
Population: Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LVEF - Change From Baseline | 0.37 percentage of blood volume | Standard Deviation 7.19 |
Secondary
LVID Diastole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Time frame: Baseline and 2 years
Population: Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LVID Diastole - Change From Baseline | -0.22 cm | Standard Deviation 0.65 |
Secondary
LVID Diastole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Time frame: Baseline and 6 months
Population: Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LVID Diastole - Change From Baseline | -0.48 cm | Standard Deviation 0.71 |
Secondary
LVID Systole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Time frame: Baseline and 6 months
Population: Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LVID Systole - Change From Baseline | -0.48 cm | Standard Deviation 0.71 |
Secondary
LVID Systole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Time frame: Baseline and 2 years
Population: Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LVID Systole - Change From Baseline | -0.22 cm | Standard Deviation 0.84 |
Secondary
LV Mass - Change From Baseline
Left ventricular mass. Transthoracic echocardiography parameter.
Time frame: Baseline and 6 months
Population: Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LV Mass - Change From Baseline | -26.5 g | Standard Deviation 60 |
Secondary
LV Mass - Change From Baseline
Left ventricular mass. Transthoracic echocardiography parameter.
Time frame: Baseline and 2 years
Population: Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LV Mass - Change From Baseline | -27.4 g | Standard Deviation 60.8 |
Secondary
LV Systolic Volume - Change From Baseline
Left ventricular systolic volume. Transthoracic echocardiography parameter.
Time frame: Baseline and 6 months
Population: Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LV Systolic Volume - Change From Baseline | -17.5 ml | Standard Deviation 30.2 |
Secondary
LV Systolic Volume - Change From Baseline
Left ventricular systolic volume. Transthoracic echocardiography parameter.
Time frame: Baseline and 2 years
Population: Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LV Systolic Volume - Change From Baseline | -11.1 ml | Standard Deviation 29.1 |
Secondary
Mean Gradient - Change From Baseline
Transthoracic echocardiography parameter
Time frame: Baseline and 2 years
Population: Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Mean Gradient - Change From Baseline | 3.1 mm Hg | Standard Deviation 5.3 |
Secondary
Mean Gradient - Change From Baseline
Transthoracic echocardiography parameter
Time frame: Baseline and 6 months
Population: Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Mean Gradient - Change From Baseline | 2.6 mm Hg | Standard Deviation 3.7 |
Secondary
New York Heart Association (NYHA) Functional Capacity Classification at 2 Years
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
Time frame: 2 years
Population: Participants with an evaluation of this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HAART 300 Annuloplasty Device | New York Heart Association (NYHA) Functional Capacity Classification at 2 Years | I | 28 participants |
| HAART 300 Annuloplasty Device | New York Heart Association (NYHA) Functional Capacity Classification at 2 Years | II | 9 participants |
| HAART 300 Annuloplasty Device | New York Heart Association (NYHA) Functional Capacity Classification at 2 Years | III | 1 participants |
| HAART 300 Annuloplasty Device | New York Heart Association (NYHA) Functional Capacity Classification at 2 Years | IV | 0 participants |
Secondary
New York Heart Association (NYHA) Functional Capacity Classification at 6 Months
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
Time frame: 6 months
Population: Participants with an evaluation of this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HAART 300 Annuloplasty Device | New York Heart Association (NYHA) Functional Capacity Classification at 6 Months | I | 30 participants |
| HAART 300 Annuloplasty Device | New York Heart Association (NYHA) Functional Capacity Classification at 6 Months | II | 13 participants |
| HAART 300 Annuloplasty Device | New York Heart Association (NYHA) Functional Capacity Classification at 6 Months | III | 0 participants |
| HAART 300 Annuloplasty Device | New York Heart Association (NYHA) Functional Capacity Classification at 6 Months | IV | 0 participants |
Secondary
Peak Gradient - Change From Baseline
Transthoracic echocardiography parameter
Time frame: Baseline and 2 years
Population: Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Peak Gradient - Change From Baseline | 5.9 mm Hg | Standard Deviation 10.7 |
Secondary
Peak Gradient - Change From Baseline
Transthoracic echocardiography parameter
Time frame: Baseline and 6 months
Population: Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Peak Gradient - Change From Baseline | 5.3 mm Hg | Standard Deviation 6.7 |
Secondary
Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HAART 300 Annuloplasty Device | Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure | 97.6 percentage of participants |