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

This study has been completed.
Information provided by (Responsible Party):
Valtech Cardio Ltd Identifier:
First received: June 7, 2012
Last updated: June 29, 2016
Last verified: June 2016
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 ]
  • • Percentage of patients in whom the size of the ring is adjusted [ Time Frame: 6 months ]
  • • Technical feasibility of adjustment. [ Time Frame: 6 months ]
    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 ]

Enrollment: 45
Study Start Date: May 2012
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 identifier: NCT01617720

SANA Herzchirurgie
Stuttgart, Germany, 70174
Hospital San Rafaele
Milan, Italy, 20132
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

Publications automatically indexed to this study by Identifier (NCT Number):
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 29, 2016

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 27, 2017