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

Edwards Lifesciences

Status: Completed

Conditions: Mitral Regurgitation

Study type: Observational

Funder types: Industry

Identifiers

NCT01617720

VC1-2

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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