The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance

Biostable Science & Engineering68 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Insufficiency

Interventions

HAART 300 Annuloplasty DeviceDEVICE

Implantation of HAART 300 Annuloplasty Device for aortic valve repair

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Institute of Clinical and Experimental Medicine

Prague, Czechia

German Heart Center

Berlin, Germany

Uniklinik Köln

Cologne, Germany

Klinik für Herz und Gefässchirurgie

Freiburg im Breisgau, Germany

Outcomes

Primary Outcomes

Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure

Time frame: 6 months

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

Secondary Outcomes

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

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

Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure

Time frame: 2 years

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

Data from ClinicalTrials.gov

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