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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
  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
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: NCT00727012

Locations
Germany
University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Raffaele De Simone, Prof. Dr. Heidelberg University
  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
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases

ClinicalTrials.gov processed this record on November 27, 2014