MITRAFIT- Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)

This study is currently recruiting participants.
Verified June 2012 by Valtech Cardio Ltd
Information provided by (Responsible Party):
Valtech Cardio Ltd Identifier:
First received: June 7, 2012
Last updated: June 10, 2012
Last verified: June 2012

This Study is designed to observe the clinical outcomes of patients requiring mitral repair that were treated with the CE certified Cardinal System.

Mitral Regurgitation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: MITRAFIT Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)

Further study details as provided by Valtech Cardio Ltd:

Primary Outcome Measures:
  • • Ability of the Cardinal ring to reduce mitral valve regurgitation [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  • • Percentage of patients in whom the size of the ring is adjusted [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • • Technical feasibility of adjustment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The ability of the surgeon to adjust the Cardinal ring when required, will be measured on a scale of 1-3 (1- successfull, 3- unsuccessful)

  • • The occurrence of serious device related adverse events in all patients. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: May 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who are candidate for mitral valve repair, with our without concomitant procedures.


Inclusion Criteria:

  • Age > 18 years
  • Patient is a candidate for mitral valve repair, with our without concomitant procedures.
  • Subject is willing to give informed consent for collection of his/her clinical data.

Exclusion Criteria:

  • Severe organic lesions with retracted chordae
  • Congenital malformations with lack of valvular tissue
  • Severe valvular calcifications
  • Evolving bacterial endocarditis
  • Known Sensitivity to Nickel or Chromium
  Contacts and Locations
Please refer to this study by its identifier: NCT01617720

Contact: Francesco Maisano, Dr. 39-02-26437111

SANA Herzchirurgie Recruiting
Stuttgart, Germany, 70174
Contact: Markus Czesla, Dr. MD         
Hospital San Rafaele Recruiting
Milan, Italy, 20132
Contact: Francesco Maisano, Dr. MD         
Sponsors and Collaborators
Valtech Cardio Ltd
Principal Investigator: Ottavio Alfieri, Prof, MD Hospital San Raffaele, Milan, Italy
Principal Investigator: Nicolas Doll, Prof, MD SANA Herzchirurgie Stuttgart , Germany
Principal Investigator: Ehud Raanani, Prof, MD Sheba medical center, Israel
Principal Investigator: Patrik Nataf, Prof, MD Bichat Hospital, Paris, France
Principal Investigator: Volkmar Falk, Prof, MD Zurich University, Zurich, Switzerland
  More Information

No publications provided

Responsible Party: Valtech Cardio Ltd Identifier: NCT01617720     History of Changes
Other Study ID Numbers: VC1-2
Study First Received: June 7, 2012
Last Updated: June 10, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Valtech Cardio Ltd:
mitral regurgitation

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases processed this record on April 17, 2014