HAART Model 300 Annuloplasty Ring

Not Applicable

Completed

Conditions: Aortic Regurgitation

Interventions: Device: HAART 300 Annuloplasty Device

Registration Number: NCT01400841

Lead Sponsor: Biostable Science & Engineering

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 18

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%

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HAART 300 Annuloplasty Device	HAART 300 Annuloplasty Device	Implantation of HAART 300 Annuloplasty Device for aortic valve repair

Primary Outcome Measures

Name	Time	Method
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+)
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 Safety Outcome Measure: Event-free Survival	2 years postprocedure (extended follow-up)	Event-free survival is defined as survival free from device-related death

Secondary Outcome Measures

Name	Time	Method
Event-free Survival	6 months postprocedure	Event-free survival is defined as survival free from device-related death
LVID Systole - Change From Baseline	Baseline, 2 years postprocedure (extended follow-up)	Left ventricular internal dimension. Transthoracic echocardiography parameter.
LV Diastolic Volume - Change From Baseline	Baseline, 2 years postprocedure (extended follow-up)	Left ventricular diastolic volume. Transthoracic echocardiography parameter.
New York Heart Association (NYHA) Functional Capacity Classification	2 years postprocedure (extended follow-up)	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, 2 years postprocedure (extended follow-up)	Transthoracic echocardiography parameter
Mean Gradient - Change From Baseline	Baseline, 2 years postprocedure (extended follow-up)	Transthoracic echocardiography parameter
Implant Procedure Success	2 years postprocedure (extended follow-up)	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.
Actuarial Freedom From Clinical Cardiovascular Events	2 years postprocedure	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
LVID Diastole - Change From Baseline	Baseline, 2 years postprocedure (extended follow-up)	Left ventricular internal dimension. Transthoracic echocardiography parameter.
LV Mass - Change From Baseline	Baseline, 2 years postprocedure (extended follow-up)	Left ventricular mass. Transthoracic echocardiography parameter.
LV Systolic Volume - Change From Baseline	Baseline, 2 years postprocedure (extended follow-up)	Left ventricular systolic volume. Transthoracic echocardiography parameter.
LVEF - Change From Baseline	Baseline, 2 years postprocedure (extended follow-up)	Left ventricular ejection fraction. Transthoracic echocardiography parameter.
Cardiac Output - Change From Baseline	Baseline, 2 years postprocedure (extended follow-up)	Stroke volume x heart rate. Transthoracic echocardiography parameter.
Cardiac Index - Change From Baseline	Baseline, 2 years postprocedure (extended follow-up)	Hemodynamic parameter computed as cardiac output divided by body surface area

Trial Locations

Locations (4): University Hospital Gasthuisberg
🇧🇪
Leuven, Belgium
German Heart Institute
🇩🇪
Berlin, Germany
German Heart Center Munich
🇩🇪
Munich, Germany
Institut klinicke a experimantalni mediciny
🇨🇿
Prague, Czech Republic