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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Aortic Regurgitation
- Sponsor
- Biostable Science & Engineering
- Enrollment
- 18
- Locations
- 4
- Primary Endpoint
- Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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%)
Outcomes
Primary Outcomes
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure
Time Frame: 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+)
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure
Time Frame: 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 Safety Outcome Measure: Event-free Survival
Time Frame: 2 years postprocedure (extended follow-up)
Event-free survival is defined as survival free from device-related death
Secondary Outcomes
- Event-free Survival(6 months postprocedure)
- LVID Systole - Change From Baseline(Baseline, 2 years postprocedure (extended follow-up))
- LV Diastolic Volume - Change From Baseline(Baseline, 2 years postprocedure (extended follow-up))
- New York Heart Association (NYHA) Functional Capacity Classification(2 years postprocedure (extended follow-up))
- Peak Gradient - Change From Baseline(Baseline, 2 years postprocedure (extended follow-up))
- Mean Gradient - Change From Baseline(Baseline, 2 years postprocedure (extended follow-up))
- Implant Procedure Success(2 years postprocedure (extended follow-up))
- Actuarial Freedom From Clinical Cardiovascular Events(2 years postprocedure)
- LVID Diastole - Change From Baseline(Baseline, 2 years postprocedure (extended follow-up))
- LV Mass - Change From Baseline(Baseline, 2 years postprocedure (extended follow-up))
- LV Systolic Volume - Change From Baseline(Baseline, 2 years postprocedure (extended follow-up))
- LVEF - Change From Baseline(Baseline, 2 years postprocedure (extended follow-up))
- Cardiac Output - Change From Baseline(Baseline, 2 years postprocedure (extended follow-up))
- Cardiac Index - Change From Baseline(Baseline, 2 years postprocedure (extended follow-up))