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Clinical Trials/NCT01617720
NCT01617720
Completed
Not Applicable

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

Edwards Lifesciences2 sites in 2 countries45 target enrollmentMay 2012
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ConditionsMitral Regurgitation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mitral Regurgitation
Sponsor
Edwards Lifesciences
Enrollment
45
Locations
2
Primary Endpoint
• Ability of the Cardinal ring to reduce mitral valve regurgitation
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
June 2016
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Edwards Lifesciences
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

• 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

Study Sites (2)

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