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

Edwards Lifesciences45 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Mitral Regurgitation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (2)

SANA Herzchirurgie

Stuttgart, Germany

Hospital San Rafaele

Milan, Italy

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.

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)

Time frame: 6 months

• The occurrence of serious device related adverse events in all patients.

Time frame: 6 months

Data from ClinicalTrials.gov

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