The HAART 300 Annuloplasty Ring Extended Safety and Performance Trial Used in Surgical Repair of the Aortic Valve

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biostable Science & Engineering
ClinicalTrials.gov Identifier:
NCT01732835
First received: November 20, 2012
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Aortic Insufficiency
Device: HAART 300 Annuloplasty Ring

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HAART 300 Trial Extended Safety and Performance

Further study details as provided by Biostable Science & Engineering:

Primary Outcome Measures:
  • Survival defined as survival free from all cause death at 6 months post procedure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: December 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01732835

Locations
Czech Republic
Institute of Clinical and Experimental Medicine
Prague, Czech Republic, 140 21
Germany
German Heart Center
Berlin, Germany, 80636
Klinik für Herz und Gefässchirurgie
Freiburg, Germany, 79106
Klinik und Poliklinik für Herz- und Gefäßchirurgie
Hamburg, Germany, 20246
Hannover Medical School (MHH)
Hannover, Germany, 30625
Uniklinik Köln
Köln, Germany, 50937
Munchen Heart Center
Munchen, Germany
Klinikum Nürnberg Süd
Nürnberg, Germany, 90471
Sponsors and Collaborators
Biostable Science & Engineering
Investigators
Principal Investigator: Dominico Mazzitelli, MD Munchen Heart Center
  More Information

No publications provided

Responsible Party: Biostable Science & Engineering
ClinicalTrials.gov Identifier: NCT01732835     History of Changes
Other Study ID Numbers: TP-01-022
Study First Received: November 20, 2012
Last Updated: June 9, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biostable Science & Engineering:
Aortic Insufficiency (AI) Aortic Regurgitation (AR)

Additional relevant MeSH terms:
Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014