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Trial record 1 of 1 for:    Cardinal Mitrafit
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MITRAFIT- Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS) (MITRAFIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 7, 2012
First Posted Date June 12, 2012
Last Update Posted Date June 30, 2016
Study Start Date May 2012
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 10, 2012)
  • • 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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01617720 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MITRAFIT- Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)
Official Title MITRAFIT Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who are candidate for mitral valve repair, with our without concomitant procedures.
Condition Mitral Regurgitation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Sündermann SH, Czesla M, Kempfert J, Walther T, Nataf P, Raanani E, Jacobs S, Alfieri O, Maisano F, Falk V. Results of mitral valve repair with an adjustable annuloplasty ring 2 years after implantation. Heart Vessels. 2017 Jul;32(7):843-849. doi: 10.1007/s00380-016-0934-7. Epub 2016 Dec 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 10, 2012)
45
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany,   Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01617720
Other Study ID Numbers VC1-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Edwards Lifesciences
Study Sponsor Edwards Lifesciences
Collaborators Not Provided
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
PRS Account Edwards Lifesciences
Verification Date June 2016