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

Completed

• Conditions: Mitral Regurgitation

• Registration Number: NCT01617720
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-07
• Study First Submitted QC: 2012-06-10
• Study First Posted: 2012-06-12
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-29
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Ability of the Cardinal ring to reduce mitral valve regurgitation	30 day
• Percentage of patients in whom the size of the ring is adjusted	6 months
• Technical feasibility of adjustment.	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.	6 months

Trial Locations

Locations (2)

SANA Herzchirurgie; 🇩🇪 Stuttgart, Germany

Hospital San Rafaele; 🇮🇹 Milan, Italy