HAART Model 300 Annuloplasty Ring - Full Text View

Purpose

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

Condition	Intervention
Aortic Regurgitation	Device: HAART 300 Annuloplasty Device

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Further study details as provided by Biostable Science & Engineering:

Primary Outcome Measures:

Primary Study Objective is to evaluate the safety and efficacy of the HAART model 300 annuloplasty ring in subjects with predominant aortic regurgitation [ Time Frame: Immediate Post-op, 1, 3 and 6 months post-op ] [ Designated as safety issue: Yes ]

Enrollment:	16
Study Start Date:	January 2012
Study Completion Date:	April 2013
Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Aortic Regurgitation

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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 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 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 LVEF > 50%

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400841

Locations

Belgium
University Hospital Gasthuisberg
Leuven, Belgium, B-3000
Czech Republic
Institut klinicke a experimantalni mediciny
Prague, Czech Republic, 1958/9
Germany
German Heart Institute
Berlin, Germany, 13353
German Heart Center Munich
Munich, Germany, 80636

Sponsors and Collaborators

Biostable Science & Engineering

Investigators

Principal Investigator:

Christof Stamm, M.D.

German Heart Institute Berlin

More Information

No publications provided

Responsible Party:	Biostable Science & Engineering
ClinicalTrials.gov Identifier:	NCT01400841 History of Changes
Other Study ID Numbers:	BSE 300
Study First Received:	July 21, 2011
Last Updated:	April 22, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biostable Science & Engineering:

Aortic Insufficiency, Aortic Regurgitation, Aortic Valve Repair

Additional relevant MeSH terms:

Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013