HAART Model 300 Annuloplasty Ring

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biostable Science & Engineering
ClinicalTrials.gov Identifier:
NCT01400841
First received: July 21, 2011
Last updated: July 8, 2013
Last verified: July 2013
  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:
    Device: HAART 300 Annuloplasty Device
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Biostable Science & Engineering

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: July 8, 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
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases

ClinicalTrials.gov processed this record on October 21, 2014