The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance

NCT ID: NCT01732835

Last Updated: 2017-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-11-30

Brief Summary

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.

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.

Conditions

Aortic Insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HAART 300 Annuloplasty Device

Implantation of HAART 300 Annuloplasty Device for aortic valve repair

Group Type: EXPERIMENTAL

HAART 300 Annuloplasty Device

Intervention Type: DEVICE

Implantation of HAART 300 Annuloplasty Device for aortic valve repair

Interventions

HAART 300 Annuloplasty Device

Implantation of HAART 300 Annuloplasty Device for aortic valve repair

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biostable Science & Engineering

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dominico Mazzitelli, MD

Role: PRINCIPAL_INVESTIGATOR

Munchen Heart Center

Locations

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

Klinik und Poliklinik für Herz- und Gefäßchirurgie

Hamburg, , Germany

Hannover Medical School (MHH)

Hanover, , Germany

Munchen Heart Center

München, , Germany

Klinikum Nürnberg Süd

Nuremberg, , Germany

Countries

Czechia; Germany

Other Identifiers

TP-01-022

Identifier Type: -

Identifier Source: org_study_id