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

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ClinicalTrials.gov Identifier: NCT01617720
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

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

Condition or disease
Mitral Regurgitation

Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MITRAFIT Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)
Study Start Date : May 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016



Primary Outcome Measures :
  1. • Ability of the Cardinal ring to reduce mitral valve regurgitation [ Time Frame: 30 day ]
  2. • Percentage of patients in whom the size of the ring is adjusted [ Time Frame: 6 months ]
  3. • 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)

  4. • The occurrence of serious device related adverse events in all patients. [ Time Frame: 6 months ]


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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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617720


Locations
Germany
SANA Herzchirurgie
Stuttgart, Germany, 70174
Italy
Hospital San Rafaele
Milan, Italy, 20132
Sponsors and Collaborators
Edwards Lifesciences
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01617720     History of Changes
Other Study ID Numbers: VC1-2
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016

Keywords provided by Edwards Lifesciences:
mitral
valve
annuloplasty
mitral regurgitation

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