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Multicenter International Trial Ring AnnulopLasty (MITRAL)

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00727012
First received: July 29, 2008
Last updated: July 12, 2011
Last verified: July 2011
History of Changes
  Purpose

This clinical study is a multicenter, prospective non-randomized observational study without concurrent or matched controls in which 150 patients receiving an SJM® Rigid Saddle Ring will be included. The primary objective of the study is to demonstrate the effectiveness of the SJM® Rigid Saddle Ring when used in mitral valve repair procedures.


Condition Intervention
Mitral Valve Insufficiency
 Device: mitral valve repair (SJM® Rigid Saddle Ring)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter International Trial Ring AnnulopLasty

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Change in ERO (Effective Regurgitant Orifice) in cm2 calculated with PISA method at 6 months and at patient discharge compared to baseline (pre-operative). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • NYHA class [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse events rates [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 180
Study Start Date: June 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SJM® Rigid Saddle Ring
The SJM® Rigid Saddle Ring is an annuloplasty ring comprised of a titanium core surrounded by a double-velour, polyester fabric sewing cuff.
 Device: mitral valve repair (SJM® Rigid Saddle Ring)
mitral valve repair due to mitral degenerative or functional disease

  Eligibility

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

Inclusion Criteria:

  • Patient requiring a mitral valve repair due to mitral degenerative or functional disease (Note: Patients that underwent concomitant procedures, e.g. coronary artery bypass grafting, are eligible for this study);
  • Patient (or legal guardian) has signed a study specific informed consent form agreeing to the data collection and follow-up requirements;
  • Patients are at least 18 years old.

Exclusion Criteria:

  • Patient requires replacement of the aortic, tricuspid or pulmonary valve or has a pre-existing prosthetic valve;
  • Patient is pregnant or nursing;
  • Patient has active endocarditis;
  • Patient is actively participating in another study of an investigational drug or device;
  • Patients unavailable to follow-up visit (abroad residents, patients affected by neurological disorders...);
  • Patients who are intravenous drug abusers, alcohol abusers, prison inmates or unable to give informed consent;
  • Patients with a major non-cardiac evolving disease;
  • Patients with a life expectancy less than 1 year;
  • Patients are known to be noncompliant or are unlikely to complete the study;
  • Any case in which mitral annuloplasty rings are not indicated;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727012

Locations
Germany
University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Raffaele De Simone, Prof. Dr. University of Heidelberg
  More Information

No publications provided

Responsible Party: Prof. Dr. Raffaele De Simone, University of Heidelberg
ClinicalTrials.gov Identifier: NCT00727012     History of Changes
Other Study ID Numbers: CS06003RG
Study First Received: July 29, 2008
Last Updated: July 12, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by St. Jude Medical:
mitral valve
heart valve
valve repair
 valve disorder
valve disease
cardiac surgery

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

ClinicalTrials.gov processed this record on May 16, 2013