HAART Model 300 Annuloplasty Ring

Biostable Science & Engineering18 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Regurgitation

Interventions

HAART 300 Annuloplasty DeviceDEVICE

Implantation of device for aortic valve repair

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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%

Locations (4)

University Hospital Gasthuisberg

Leuven, Belgium

Institut klinicke a experimantalni mediciny

Prague, Czechia

German Heart Institute

Berlin, Germany

German Heart Center Munich

Munich, Germany

Outcomes

Primary Outcomes

Primary Safety Outcome Measure: Event-free Survival

Event-free survival is defined as survival free from device-related death

Time frame: 1 month postprocedure

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)

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

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)

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 * 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

Implant Procedure Success

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 2 years postprocedure (extended follow-up)

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

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

Event-free Survival

Event-free survival is defined as survival free from device-related death

Time frame: 6 months postprocedure

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

New York Heart Association (NYHA) Functional Capacity Classification

Time frame: 2 years postprocedure (extended follow-up)

Peak Gradient - Change From Baseline

Transthoracic echocardiography parameter

Time frame: Baseline, 6 months postprocedure

Peak Gradient - Change From Baseline

Transthoracic echocardiography parameter