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

This study is currently recruiting participants.
Verified June 2012 by Valtech Cardio Ltd
Sponsor:
Information provided by (Responsible Party):
Valtech Cardio Ltd
ClinicalTrials.gov Identifier:
NCT01617720
First received: June 7, 2012
Last updated: June 10, 2012
Last verified: June 2012
  Purpose

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


Condition
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)
  Eligibility

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.

Criteria

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 ClinicalTrials.gov identifier: NCT01617720

Contacts
Contact: Francesco Maisano, Dr. 39-02-26437111 francesco.maisano@hsr.it

Locations
Germany
SANA Herzchirurgie Recruiting
Stuttgart, Germany, 70174
Contact: Markus Czesla, Dr. MD         
Italy
Hospital San Rafaele Recruiting
Milan, Italy, 20132
Contact: Francesco Maisano, Dr. MD         
Sponsors and Collaborators
Valtech Cardio Ltd
Investigators
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
ClinicalTrials.gov 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
valve
annuloplasty
mitral regurgitation

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014