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OpenTrials
Completed

NCT Number: NCT00727012

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Heidelberg

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

mitral valve repair (SJM® Rigid Saddle Ring)

Device

mitral valve repair due to mitral degenerative or functional disease

Primary outcomes

  1. 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

  2. NYHA class

    Time frame: 6 months

Secondary outcomes

  1. adverse events rates

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: MITRAL

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 1, 2008
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.