Aortic Regurgitation
Conditions
Keywords
Aortic Insufficiency, Aortic Regurgitation, Aortic Valve Repair
Brief summary
This investigation is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically repair a leaking 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. Therefore, potentially aortic valve repair is a good option for patients with AR or AI.
Interventions
Implantation of 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
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is 50 years old or older * The subject has a tricuspid aortic valve morphology * Patients with documented severe aortic insufficiency with aortic annular dilation without severe concomitant aortic stenosis * Patients referred to center for documented moderate to severe Chronic aortic regurgitation (AR) associated with annular dilatation with or without cusp prolapse of one, two, or all three leaflets * Patients with or without Sinotubular Junction (STJ) dilatation or aortic root aneurysms * Patients who are free of coronary disease or those with evidence of minor stable (1-2 vessel) coronary disease * Subject is willing to comply with specified follow-up evaluations, including transesophageal echocardiography if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve * The subject has signed the written informed consent * The subject agrees to return for all follow-up evaluations for the duration of the study (i.e. geographically stable * The subject is New York Hospital Association (NYHA) class II or III
Exclusion criteria
* The subject has preexisting valve prosthesis in the atrial, the mitral, pulmonary, and/or tricuspid position * The subject requires an additional valve replacement * The subject's aortic valve morphology is not tricuspid * The subject has active endocarditis * Heavily calcified valves * Valvular retraction with severely reduced mobility * The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis * The subject requires a repair of the mitral or tricuspid valve with the use of an annuloplasty device * 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 * Non elective presentation * Low Ejection Fraction (EF) EF \< 40% * Life expectancy \< 1 year * Rheumatic disease * The subject has severe leaflet fenestration or leaflets damaged by endocarditis * 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 * This patient will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up * The subject has not signed and dated the study informed consent * Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA) * Myocardial infarction (MI) within one month of trial inclusion * Have a known intolerance to titanium or polyester * Sole therapy for correction for patients with aortic root aneurysm * Subjects requiring simultaneous cardiac procedures * The subject has asymptomatic AR and a left ventricular ejection fraction (LVEF) \> 50%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Outcome Measure: Event-free Survival | 1 month postprocedure | Event-free survival is defined as survival free from device-related death |
| Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure | 6 months postprocedure | Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+) |
| Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure | 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+) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Peak Gradient - Change From Baseline | Baseline, 6 months postprocedure | Transthoracic echocardiography parameter |
| Mean Gradient - Change From Baseline | Baseline, 6 months postprocedure | Transthoracic echocardiography parameter |
| LV Mass - Change From Baseline | Baseline, 6 months postprocedure | Left ventricular mass. Transthoracic echocardiography parameter. |
| LVID Diastole - Change From Baseline | Baseline, 6 months postprocedure | Left ventricular internal dimension. 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 * 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. |
| LV Diastolic Volume - Change From Baseline | Baseline, 6 months postprocedure | Left ventricular diastolic volume. Transthoracic echocardiography parameter. |
| LV Systolic Volume - Change From Baseline | Baseline, 6 months postprocedure | Left ventricular systolic volume. Transthoracic echocardiography parameter. |
| LVEF - Change From Baseline | Baseline, 6 months postprocedure | Left ventricular ejection fraction. Transthoracic echocardiography parameter. |
| Cardiac Output - Change From Baseline | Baseline, 6 months postprocedure | Stroke volume x heart rate. Transthoracic echocardiography parameter. |
| Cardiac Index - Change From Baseline | Baseline, 6 months postprocedure | Hemodynamic parameter computed as cardiac output divided by body surface area |
| LVID Systole - Change From Baseline | Baseline, 6 months postprocedure | Left ventricular internal dimension. Transthoracic echocardiography parameter. |
| Actuarial Freedom From Clinical Cardiovascular Events | 1 month postprocedure | Freedom 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 |
| Event-free Survival | 6 months postprocedure | Event-free survival is defined as survival free from device-related death |
Countries
Belgium, 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 device for aortic valve repair | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Extended Study Phase (2 Years) | Adverse Event | 2 |
| Initial Study Phase (6 Months) | Death | 1 |
Baseline characteristics
| Characteristic | HAART 300 Annuloplasty Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 68.1 years STANDARD_DEVIATION 9.3 |
| Aortic Valvular Regurgitation 0 | 0 participants |
| Aortic Valvular Regurgitation 1+ | 0 participants |
| Aortic Valvular Regurgitation 2+ | 6 participants |
| Aortic Valvular Regurgitation 3+ | 7 participants |
| Aortic Valvular Regurgitation 4+ | 3 participants |
| Cardiac index | 3.41 l/min/m^2 STANDARD_DEVIATION 0.9 |
| Cardiac output | 6.77 l/min STANDARD_DEVIATION 1.6 |
| Gender Female | 3 Participants |
| Gender Male | 13 Participants |
| Left ventricular ejection fraction (LVEF) | 53.2 % STANDARD_DEVIATION 6.7 |
| Left ventricular internal dimension (LVID) diastole | 5.44 cm STANDARD_DEVIATION 0.6 |
| Left ventricular (LV) mass | 260.0 g STANDARD_DEVIATION 57.1 |
| LV diastolic volume | 180.7 ml STANDARD_DEVIATION 50.2 |
| LVID systole | 4.09 cm STANDARD_DEVIATION 0.76 |
| LV systolic volume | 84.7 ml STANDARD_DEVIATION 25.4 |
| Mean gradient | 6.8 mm Hg STANDARD_DEVIATION 3 |
| NYHA Classification I | 0 participants |
| NYHA Classification II | 10 participants |
| NYHA Classification III | 6 participants |
| NYHA Classification IV | 0 participants |
| Peak gradient | 13.3 mm Hg STANDARD_DEVIATION 6.2 |
| Region of Enrollment Belgium | 1 participants |
| Region of Enrollment Czech Republic | 2 participants |
| Region of Enrollment Germany | 13 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 16 |
| serious Total, serious adverse events | 8 / 16 |
Outcome results
Primary
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure
Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
Time frame: 2 years postprocedure (extended follow-up)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure | 0 | 2 participants |
| HAART 300 Annuloplasty Device | Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure | 1+ | 7 participants |
| HAART 300 Annuloplasty Device | Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure | 2+ | 2 participants |
| HAART 300 Annuloplasty Device | Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure | 3+ | 0 participants |
| HAART 300 Annuloplasty Device | Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure | 4+ | 0 participants |
Primary
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure
Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
Time frame: 6 months postprocedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure | 0 | 2 participants |
| HAART 300 Annuloplasty Device | Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure | 1+ | 9 participants |
| HAART 300 Annuloplasty Device | Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure | 2+ | 3 participants |
| HAART 300 Annuloplasty Device | Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure | 3+ | 1 participants |
| HAART 300 Annuloplasty Device | Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure | 4+ | 0 participants |
Primary
Primary Safety Outcome Measure: Event-free Survival
Event-free survival is defined as survival free from device-related death
Time frame: 1 month postprocedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HAART 300 Annuloplasty Device | Primary Safety Outcome Measure: Event-free Survival | 100 percentage of participants |
Primary
Primary Safety Outcome Measure: Event-free Survival
Event-free survival is defined as survival free from device-related death
Time frame: 2 years postprocedure (extended follow-up)
Population: Extended follow-up participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HAART 300 Annuloplasty Device | Primary Safety Outcome Measure: Event-free Survival | 100 percentage of participants |
Secondary
Actuarial Freedom From Clinical Cardiovascular Events
Freedom 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
Time frame: 2 years postprocedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HAART 300 Annuloplasty Device | Actuarial Freedom From Clinical Cardiovascular Events | 81.5 percentage of implant procedures |
Secondary
Actuarial Freedom From Clinical Cardiovascular Events
Freedom 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
Time frame: 1 month postprocedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HAART 300 Annuloplasty Device | Actuarial Freedom From Clinical Cardiovascular Events | 100 percentage of implant procedures |
Secondary
Cardiac Index - Change From Baseline
Hemodynamic parameter computed as cardiac output divided by body surface area
Time frame: Baseline, 2 years postprocedure (extended follow-up)
Population: Both baseline and 2-year measure available for 5 of 11 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Cardiac Index - Change From Baseline | -0.22 l/min/m^2 | Standard Deviation 0.18 |
Secondary
Cardiac Index - Change From Baseline
Hemodynamic parameter computed as cardiac output divided by body surface area
Time frame: Baseline, 6 months postprocedure
Population: Both baseline and 6-month measure available for 7 of 15 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Cardiac Index - Change From Baseline | -0.40 l/min/m^2 | Standard Deviation 0.8 |
Secondary
Cardiac Output - Change From Baseline
Stroke volume x heart rate. Transthoracic echocardiography parameter.
Time frame: Baseline, 6 months postprocedure
Population: Both baseline and 6-month measure available for 7 of 15 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Cardiac Output - Change From Baseline | -0.73 l/min | Standard Deviation 1.55 |
Secondary
Cardiac Output - Change From Baseline
Stroke volume x heart rate. Transthoracic echocardiography parameter.
Time frame: Baseline, 2 years postprocedure (extended follow-up)
Population: Both baseline and 2-year measure available for 5 of 11 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Cardiac Output - Change From Baseline | -0.36 l/min | Standard Deviation 0.34 |
Secondary
Event-free Survival
Event-free survival is defined as survival free from device-related death
Time frame: 6 months postprocedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HAART 300 Annuloplasty Device | Event-free Survival | 100 percentage of participants |
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 * 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.
Time frame: 2 years postprocedure (extended follow-up)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HAART 300 Annuloplasty Device | Implant Procedure Success | 87.5 percentage of implant procedures |
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 * 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.
Time frame: discharge or 14 days postprocedure, whichever comes first
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HAART 300 Annuloplasty Device | Implant Procedure Success | 100 percentage of implant procedures |
Secondary
LV Diastolic Volume - Change From Baseline
Left ventricular diastolic volume. Transthoracic echocardiography parameter.
Time frame: Baseline, 6 months postprocedure
Population: Both baseline and 6-month measure available for 7 of 15 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LV Diastolic Volume - Change From Baseline | -49.9 ml | Standard Deviation 64.2 |
Secondary
LV Diastolic Volume - Change From Baseline
Left ventricular diastolic volume. Transthoracic echocardiography parameter.
Time frame: Baseline, 2 years postprocedure (extended follow-up)
Population: Both baseline and 2-year measure available for 5 of 11 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LV Diastolic Volume - Change From Baseline | -75.4 ml | Standard Deviation 74.3 |
Secondary
LVEF - Change From Baseline
Left ventricular ejection fraction. Transthoracic echocardiography parameter.
Time frame: Baseline, 6 months postprocedure
Population: Both baseline and 6-month measure available for 7 of 15 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LVEF - Change From Baseline | 5.13 percentage of blood volume | Standard Deviation 6.53 |
Secondary
LVEF - Change From Baseline
Left ventricular ejection fraction. Transthoracic echocardiography parameter.
Time frame: Baseline, 2 years postprocedure (extended follow-up)
Population: Both baseline and 2-year measure available for 5 of 11 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LVEF - Change From Baseline | 12.20 percentage of blood volume | Standard Deviation 9.57 |
Secondary
LVID Diastole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Time frame: Baseline, 6 months postprocedure
Population: Both baseline and 6-month measure available for 8 of 15 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LVID Diastole - Change From Baseline | -0.52 cm | Standard Deviation 0.61 |
Secondary
LVID Diastole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Time frame: Baseline, 2 years postprocedure (extended follow-up)
Population: Both baseline and 2-year measure available for 7 of 11 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LVID Diastole - Change From Baseline | -0.33 cm | Standard Deviation 0.82 |
Secondary
LVID Systole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Time frame: Baseline, 2 years postprocedure (extended follow-up)
Population: Both baseline and 2-year measure available for 3 of 11 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LVID Systole - Change From Baseline | 0.03 cm | Standard Deviation 1.09 |
Secondary
LVID Systole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Time frame: Baseline, 6 months postprocedure
Population: Both baseline and 6-month measure available for 5 of 15 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LVID Systole - Change From Baseline | -0.75 cm | Standard Deviation 0.68 |
Secondary
LV Mass - Change From Baseline
Left ventricular mass. Transthoracic echocardiography parameter.
Time frame: Baseline, 6 months postprocedure
Population: Both baseline and 6-month measure available for 8 of 15 participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LV Mass - Change From Baseline | -53.4 g | Standard Deviation 57.1 |
Secondary
LV Mass - Change From Baseline
Left ventricular mass. Transthoracic echocardiography parameter.
Time frame: Baseline, 2 years postprocedure (extended follow-up)
Population: Both baseline and 2-year measure available for 6 of 11 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LV Mass - Change From Baseline | -23.3 g | Standard Deviation 72 |
Secondary
LV Systolic Volume - Change From Baseline
Left ventricular systolic volume. Transthoracic echocardiography parameter.
Time frame: Baseline, 2 years postprocedure (extended follow-up)
Population: Both baseline and 2-year measure available for 5 of 11 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LV Systolic Volume - Change From Baseline | -48.4 ml | Standard Deviation 38.2 |
Secondary
LV Systolic Volume - Change From Baseline
Left ventricular systolic volume. Transthoracic echocardiography parameter.
Time frame: Baseline, 6 months postprocedure
Population: Both baseline and 6-month measure available for 7 of 15 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | LV Systolic Volume - Change From Baseline | -30.6 ml | Standard Deviation 30.2 |
Secondary
Mean Gradient - Change From Baseline
Transthoracic echocardiography parameter
Time frame: Baseline, 6 months postprocedure
Population: Baseline measure not available for 1 of 15 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Mean Gradient - Change From Baseline | 2.6 mm Hg | Standard Deviation 2.7 |
Secondary
Mean Gradient - Change From Baseline
Transthoracic echocardiography parameter
Time frame: Baseline, 2 years postprocedure (extended follow-up)
Population: Baseline measure not available for 1 of 11 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Mean Gradient - Change From Baseline | 4.8 mm Hg | Standard Deviation 4.8 |
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: 2 years postprocedure (extended follow-up)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HAART 300 Annuloplasty Device | New York Heart Association (NYHA) Functional Capacity Classification | I | 8 participants |
| HAART 300 Annuloplasty Device | New York Heart Association (NYHA) Functional Capacity Classification | II | 3 participants |
| HAART 300 Annuloplasty Device | New York Heart Association (NYHA) Functional Capacity Classification | III | 0 participants |
| HAART 300 Annuloplasty Device | New York Heart Association (NYHA) Functional Capacity Classification | IV | 0 participants |
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: NYHA evaluation not done on 1 of 15 participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HAART 300 Annuloplasty Device | New York Heart Association (NYHA) Functional Capacity Classification | I | 11 participants |
| HAART 300 Annuloplasty Device | New York Heart Association (NYHA) Functional Capacity Classification | II | 3 participants |
| HAART 300 Annuloplasty Device | New York Heart Association (NYHA) Functional Capacity Classification | III | 0 participants |
| HAART 300 Annuloplasty Device | New York Heart Association (NYHA) Functional Capacity Classification | IV | 0 participants |
Secondary
Peak Gradient - Change From Baseline
Transthoracic echocardiography parameter
Time frame: Baseline, 2 years postprocedure (extended follow-up)
Population: Baseline measure not available for 1 of 11 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Peak Gradient - Change From Baseline | 10.1 mm Hg | Standard Deviation 9.4 |
Secondary
Peak Gradient - Change From Baseline
Transthoracic echocardiography parameter
Time frame: Baseline, 6 months postprocedure
Population: Baseline measure not available for 1 of 15 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Peak Gradient - Change From Baseline | 4.9 mm Hg | Standard Deviation 5.6 |