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

July 29, 2008
July 12, 2011
June 2008
November 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00727012 on ClinicalTrials.gov Archive Site
adverse events rates [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Multicenter International Trial Ring AnnulopLasty
Multicenter International Trial Ring AnnulopLasty

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mitral Valve Insufficiency
Device: mitral valve repair (SJM® Rigid Saddle Ring)
mitral valve repair due to mitral degenerative or functional disease
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.
Intervention: Device: mitral valve repair (SJM® Rigid Saddle Ring)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
November 2010
November 2010   (final data collection date for primary outcome measure)

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;
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00727012
CS06003RG
No
Prof. Dr. Raffaele De Simone, University of Heidelberg
St. Jude Medical
Not Provided
Principal Investigator: Raffaele De Simone, Prof. Dr. Heidelberg University
St. Jude Medical
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP