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

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

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

Study Overview

• Status: Completed
• Conditions: Mitral Regurgitation

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Germany
  • Stuttgart, Germany, 70174
    • SANA Herzchirurgie
• Italy
  • Milan, Italy, 20132
    • Hospital San Rafaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are candidate for mitral valve repair, with our without concomitant procedures.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• 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.	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)	6 months
• The occurrence of serious device related adverse events in all patients.		6 months

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• 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; Principal Investigator: Patrik Nataf, Prof, MD, Bichat Hospital, Paris, France; Principal Investigator: Volkmar Falk, Prof, MD, Zurich University, Zurich, Switzerland

Publications and helpful links

General Publications

• Sundermann 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: June 7, 2012
• First Submitted That Met QC Criteria: June 10, 2012
• First Posted (Estimate): June 12, 2012

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: mitral regurgitation; valve; mitral; annuloplasty
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: VC1-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No