Aortic Insufficiency
Conditions
Keywords
Aortic Insufficiency, Aortic Regurgitation
Brief summary
The HAART 200 Aortic Annuloplasty during Bicuspid Aortic Valve Reconstruction Trial is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART 200 bicuspid annuloplasty ring when used to surgically stabilize the aortic valve annulus in patients undergoing repair of bicuspid aortic valves (BAV) for predominant aortic insufficiency (AI).
Detailed description
Aortic valve disease is the most common valvular heart disease with approximately 200,000 patients per year undergoing conventional aortic valve replacement in North America and Europe. Around 60% of valves have Aortic Stenosis (AS) and 40% of have Aortic Insufficiency, which is the failure of the aortic valve to close completely during diastole, causing blood to flow from the aorta back into the left ventricle. Bicuspid valve morphology is present in a fourth to a third of patients coming to surgical intervention, and constitutes a very important subset. Several conditions are associated with bicuspid disease, including ascending aortic or root aneurysms in up to a third. Traditional management of aortic valve and root disease has been with aortic valve replacement, with or without root replacement (Bentall Procedure). However, as has been observed in patients with mitral valve repair, the option of maintaining one's reconstructed native valve versus a replacement, either bioprosthetic or mechanical, can have multiple benefits. The advantages of repair include: the avoidance of prosthetic valve related complications and structural degeneration with bioprosthetic valves over 10-15 years and elimination of the need for anticoagulation and related problems with mechanical valves in younger patients. The significantly lower rate of endocarditis after repair is a major impetus to increasing performance of BAV reconstruction. Thus, aortic valve repair currently is established as an excellent option for patients with BAV. However, with connective tissue disorders being an inherent feature of BAV, outcomes have been less stable long-term than for trileaflet repair, primarily because of late annular redilatation in BAV disease. Therefore, this study is designed to evaluate the safety and effectiveness of annular stabilization with a bicuspid annuloplasty ring in patients undergoing repair of a bicuspid aortic valve for predominant aortic insufficiency.
Interventions
DEVICEHAART 200 Aortic Valve Annuloplasty Device
Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
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
1. The subject is 18 years of age or older 2. The subject has bi-leaflet aortic valve morphology 3. The subject has documented aortic valve disease which may or may not include: * Aortic valve insufficiency * Ascending aortic or aortic root pathology * Other pathology of the ascending aorta that requires elective aortic replacement * Associated stable one or two vessel coronary disease requiring concomitant coronary bypass * Patients with recurrent severe AI (Grade 3 or 4) after prior bicuspid repair who are undergoing re-repair because of annular re-dilatation * All bicuspid annular and leaflet configurations will be included 4. The subject needs: * correction of BAV annular dilatation in patients with chronic AI and dilated annulus * restoration of a circular annular shape in patients with bicuspid valve and expansion of sinus to sinus dimensions * stabilization of annular geometry long-term in rare bicuspid valve patients with severe AI and minimal annular dilatation 5. The 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 6. The subject has reviewed and signed the written informed consent form 7. The subject agrees to return for all follow-up evaluations for the duration of the study (i.e. geographically stable)
Exclusion criteria
1. All patients will be excluded who require emergency surgery for any reason. 2. All the patients who have had a prior heart valve replacement 3. The subject's aortic valve morphology is not bicuspid. 4. The subject has active endocarditis 5. The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis 6. Heavily calcified BAV valves, calcified aortic roots, or porcelain aortas 7. Leukopenia with a White Blood Cell (WBC) of less than 3000 8. Acute anemia with a Hgb less than 9mg% 9. Platelet count less than 100,000 cells/mm3 10. History of a defined bleeding diathesis or coagulopathy or the subject refuses blood transfusions 11. Active infection requiring antibiotic therapy (if temporary illness, subjects may enroll 2-4 weeks after discontinuation of antibiotics) 12. Subjects in whom transesophageal echocardiography (TEE) is contraindicated 13. Low Ejection Fraction (EF) \< 35% 14. Life expectancy \< 1 year, or severe comorbidities, such as dialysis or severe Chronic Obstructive Pulmonary Disease (COPD) 15. 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 16. The subject is a minor, an illicit drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent 17. The subject is pregnant or lactating 18. Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA) 19. Myocardial Infarction (MI) within one month of trial inclusion 20. The subject has a known intolerance to titanium or polyester 21. The subject has documented unstable or \> 2 vessel coronary disease 22. 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 postprocedure | — |
| Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months | 6 months postprocedure | Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderately 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 | Baseline and 2 years | Aortic insufficiency assessed by transthoracic echocardiography 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 | 6 months postprocedure | 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 |
| NYHA Functional Capacity Classification | 2 years postprocedure | 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 |
| Left Ventricular (LV) Mass - Change From Baseline | Baseline and 6 months | Left ventricular mass. Transthoracic echocardiography parameter. |
| LV Mass - Change From Baseline | Baseline and 2 years | 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 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. |
| LVID Diastole - Change From Baseline | Baseline and 2 years | Left ventricular internal dimension. Transthoracic echocardiography parameter. |
| 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. |
| Left Ventricular Ejection Fraction (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 |
| Left Ventricular Internal Dimension (LVID) Diastole - Change From Baseline | Baseline and 6 months | Left ventricular internal dimension. Transthoracic echocardiography parameter. |
| Actuarial Freedom From Clinical Cardiovascular Events | 6 months postprocedure | Freedom 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 |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 . | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 2-year Extended Follow-up | Adverse Event | 1 |
| 6-month Primary Endpoint | Adverse Event | 1 |
| 6-month Primary Endpoint | Did not receive device | 4 |
Baseline characteristics
| Characteristic | Aortic Valve Repair |
|---|---|
| Age, Continuous | 44.4 years STANDARD_DEVIATION 11.3 |
| Age, Customized 18-29 | 3 Participants |
| Age, Customized 30-39 | 2 Participants |
| Age, Customized 40-49 | 6 Participants |
| Age, Customized 50-59 | 4 Participants |
| Age, Customized 60-69 | 1 Participants |
| Aortic Insufficiency 0 | 1 Participants |
| Aortic Insufficiency 1+ | 3 Participants |
| Aortic Insufficiency 2+ | 2 Participants |
| Aortic Insufficiency 3+ | 5 Participants |
| Aortic Insufficiency 4+ | 3 Participants |
| Aortic Insufficiency Grade not available | 2 Participants |
| Cardiac index | 3.88 l/min/m^2 STANDARD_DEVIATION 1.16 |
| Cardiac output | 7.926 l/min STANDARD_DEVIATION 2.365 |
| Left ventricular ejection fraction (LVEF) | 53.86 percentage of blood volume STANDARD_DEVIATION 8.76 |
| Left ventricular internal dimension (LVID) diastole | 5.408 cm STANDARD_DEVIATION 0.952 |
| Left ventricular (LV) mass | 288.62 g STANDARD_DEVIATION 90.23 |
| LV diastolic volume | 144.5 ml STANDARD_DEVIATION 57.6 |
| LVID systole | 3.527 cm STANDARD_DEVIATION 0.793 |
| LV systolic volume | 69.1 ml STANDARD_DEVIATION 36.6 |
| Mean gradient | 13.4 mm Hg STANDARD_DEVIATION 12.9 |
| New York Heart Association (NYHA) Functional Capacity I | 3 Participants |
| New York Heart Association (NYHA) Functional Capacity II | 13 Participants |
| New York Heart Association (NYHA) Functional Capacity III | 0 Participants |
| New York Heart Association (NYHA) Functional Capacity IV | 0 Participants |
| Peak gradient | 25.5 mm Hg STANDARD_DEVIATION 22.3 |
| Region of Enrollment Germany | 16 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 16 / 16 |
| serious Total, serious adverse events | 8 / 16 |
Outcome results
Primary
Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months
Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderately Severe (3+), or Severe (4+)
Time frame: 6 months postprocedure
Population: Participants with an echocardiogram evaluable for this measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aortic Valve Repair | Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months | 0 | 5 Participants |
| Aortic Valve Repair | Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months | 1+ | 6 Participants |
| Aortic Valve Repair | Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months | 2+ | 4 Participants |
| Aortic Valve Repair | Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months | 3+ | 0 Participants |
| Aortic Valve Repair | 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 postprocedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aortic Valve Repair | 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 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 postprocedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aortic Valve Repair | Actuarial Freedom From Clinical Cardiovascular Events | 87.5 percentage of participants |
Secondary
Actuarial Freedom From Clinical Cardiovascular Events
Freedom 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
Time frame: 2 years postprocedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aortic Valve Repair | Actuarial Freedom From Clinical Cardiovascular Events | 81.2 percentage of participants |
Secondary
Aortic Insufficiency (AI) at 2 Years
Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
Time frame: Baseline and 2 years
Population: Participants with an echocardiogram evaluable for this measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aortic Valve Repair | Aortic Insufficiency (AI) at 2 Years | 0 | 2 Participants |
| Aortic Valve Repair | Aortic Insufficiency (AI) at 2 Years | 1+ | 11 Participants |
| Aortic Valve Repair | Aortic Insufficiency (AI) at 2 Years | 2+ | 1 Participants |
| Aortic Valve Repair | Aortic Insufficiency (AI) at 2 Years | 3+ | 0 Participants |
| Aortic Valve Repair | 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 |
|---|---|---|---|
| Aortic Valve Repair | Cardiac Index - Change From Baseline | -1.09 l/min/m^2 | Standard Deviation 1.28 |
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 |
|---|---|---|---|
| Aortic Valve Repair | Cardiac Index - Change From Baseline | -0.50 l/min/m^2 | Standard Deviation 1.5 |
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 |
|---|---|---|---|
| Aortic Valve Repair | Cardiac Output - Change From Baseline | -0.932 l/min | Standard Deviation 2.979 |
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 |
|---|---|---|---|
| Aortic Valve Repair | Cardiac Output - Change From Baseline | -2.145 l/min | Standard Deviation 2.679 |
Secondary
Implant Procedure Success
Success 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.
Time frame: discharge or 14 days postprocedure, whichever comes first
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aortic Valve Repair | Implant Procedure Success | 100 percentage of participants |
Secondary
Left Ventricular Ejection Fraction (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 |
|---|---|---|---|
| Aortic Valve Repair | Left Ventricular Ejection Fraction (LVEF) - Change From Baseline | 4.21 percentage of blood volume | Standard Deviation 10.02 |
Secondary
Left Ventricular Ejection Fraction (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 |
|---|---|---|---|
| Aortic Valve Repair | Left Ventricular Ejection Fraction (LVEF) - Change From Baseline | 0.00 percentage of blood volume | Standard Deviation 8.83 |
Secondary
Left Ventricular Internal Dimension (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 |
|---|---|---|---|
| Aortic Valve Repair | Left Ventricular Internal Dimension (LVID) Diastole - Change From Baseline | -0.306 cm | Standard Deviation 0.843 |
Secondary
Left Ventricular (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 |
|---|---|---|---|
| Aortic Valve Repair | Left Ventricular (LV) Mass - Change From Baseline | -53.98 g | Standard Deviation 76.21 |
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 |
|---|---|---|---|
| Aortic Valve Repair | LV Diastolic Volume - Change From Baseline | 26.9 ml | Standard Deviation 40.9 |
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 |
|---|---|---|---|
| Aortic Valve Repair | LV Diastolic Volume - Change From Baseline | 2.8 ml | Standard Deviation 41.3 |
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 |
|---|---|---|---|
| Aortic Valve Repair | LVID Diastole - Change From Baseline | -0.455 cm | Standard Deviation 1.023 |
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 |
|---|---|---|---|
| Aortic Valve Repair | LVID Systole - Change From Baseline | 0.030 cm | Standard Error 0.531 |
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 |
|---|---|---|---|
| Aortic Valve Repair | LVID Systole - Change From Baseline | -0.700 cm | Standard Deviation 1.108 |
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 |
|---|---|---|---|
| Aortic Valve Repair | LV Mass - Change From Baseline | -78.84 g | Standard Deviation 88 |
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 |
|---|---|---|---|
| Aortic Valve Repair | LV Systolic Volume - Change From Baseline | 1.3 ml | Standard Deviation 25.8 |
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 |
|---|---|---|---|
| Aortic Valve Repair | LV Systolic Volume - Change From Baseline | 7.9 ml | Standard Deviation 24.9 |
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 |
|---|---|---|---|
| Aortic Valve Repair | Mean Gradient - Change From Baseline | 1.2 mm Hg | Standard Deviation 13.3 |
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 |
|---|---|---|---|
| Aortic Valve Repair | Mean Gradient - Change From Baseline | 2.4 mm Hg | Standard Deviation 8.8 |
Secondary
New York Heart Association (NYHA) Functional Capacity Classification
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 postprocedure
Population: Participants with an evaluation of this measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aortic Valve Repair | New York Heart Association (NYHA) Functional Capacity Classification | I | 15 Participants |
| Aortic Valve Repair | New York Heart Association (NYHA) Functional Capacity Classification | II | 0 Participants |
| Aortic Valve Repair | New York Heart Association (NYHA) Functional Capacity Classification | III | 0 Participants |
| Aortic Valve Repair | New York Heart Association (NYHA) Functional Capacity Classification | IV | 0 Participants |
Secondary
NYHA Functional Capacity Classification
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 postprocedure
Population: Participants with an evaluation of this measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aortic Valve Repair | NYHA Functional Capacity Classification | III | 0 Participants |
| Aortic Valve Repair | NYHA Functional Capacity Classification | IV | 0 Participants |
| Aortic Valve Repair | NYHA Functional Capacity Classification | I | 14 Participants |
| Aortic Valve Repair | NYHA Functional Capacity Classification | II | 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 |
|---|---|---|---|
| Aortic Valve Repair | Peak Gradient - Change From Baseline | 1.4 mm Hg | Standard Deviation 16.3 |
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 |
|---|---|---|---|
| Aortic Valve Repair | Peak Gradient - Change From Baseline | 1.1 mm Hg | Standard Deviation 22.4 |
Secondary
Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aortic Valve Repair | Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure. | 100 percentage of participants |