Clinical Trial: Study on Safety and Performance of Medtentia Mitral Valve Repair System in Surgical Repair of Mitral Regurgitation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of the Safety and Performance of the Medtentia Mitral Valve Repair System When Used in Adults Undergoing Mitral Valve Repair Surgery

Brief Summary: The purpose of the trial is to demonstrate the safety, performance and implantability of the Medtentia Annuloplasty Ring (MAR) during mitral valve repair surgery. In addition, the trial aims to demonstrate that the MAR fulfills the requirements for mitral valve annuloplasty rings.

Detailed Summary:
Sponsor: Medtentia International Ltd Oy

Current Primary Outcome:

  • All cause mortality [ Time Frame: At hospital discharge after surgery ]
    To evaluate the safety of using the MAR and its accessories for mitral valve repair surgery, in terms of survival from surgery to hospital discharge
  • Change in mitral regurgitation from baseline to three months as measured by trans thoracic ECHO (echocardiography) [ Time Frame: 3 months after surgery ]
    Success will be defined as an improvement in at least 2 degrees in mitral regurgitation class as described in the ACC/AHA Guidelines for the Management of Patients with Valvular Heart Disease


Original Primary Outcome:

  • All cause mortality [ Time Frame: 30 days after surgery ]
    To demonstrate the safety of the MAR and accessories when used during mitral valve repair surgery, in terms of freedom from death at 30 days
  • Procedure success [ Time Frame: during surgery ]
    To demonstrate the device and procedural success of the MAR and accessories during mitral valve surgery


Current Secondary Outcome:

  • All cause mortality [ Time Frame: At 30 days, 3 months, 6 months,1 year, 1,5 years and 2 years after surgery ]
  • Occurrence frequency and timing of treatment-emergent major adverse cardiac events [ Time Frame: From surgery to end of study (2 years) ]
    Defined as stroke and clinically significant myocardial infarction
  • Mitral regurgitation as seen in trans esophageal ECHO performed during surgery before and after annuloplasty [ Time Frame: During surgery before and after the implantation ]
  • Mitral regurgitation measured with trans thoracic ECHO [ Time Frame: From 3 months until end of study (2 years) ]
  • Occurrence, nature and frequency of treatment-emergent AEs, in particular severe SADEs [ Time Frame: From surgery until end of study (2 years) ]


Original Secondary Outcome:

Information By: Medtentia International Ltd Oy

Dates:
Date Received: August 30, 2012
Date Started: June 2011
Date Completion:
Last Updated: December 21, 2016
Last Verified: December 2016