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

Mitral Regurgitation Clinical Trial

— MITRAFIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617720
• Other study ID #: VC1-2
• Status: Completed
• Start date: May 2012
• Est. completion date: June 2016

Study information

• Verified date: October 2021
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Locations

Country	Name	City	State
Germany	SANA Herzchirurgie	Stuttgart
Italy	Hospital San Rafaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Germany,  Italy, 

References & Publications (1)

Sündermann 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Ability of the Cardinal ring to reduce mitral valve regurgitation		30 day
Primary	• Percentage of patients in whom the size of the ring is adjusted		6 months
Primary	• 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
Primary	• The occurrence of serious device related adverse events in all patients.		6 months