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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01617720

Acronym

MITRAFIT

Enrollment

Registered

2012-06-12

Start date

2012-05-31

Completion date

2016-06-30

Last updated

2021-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Regurgitation

Keywords

mitral, valve, annuloplasty, mitral regurgitation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
• Percentage of patients in whom the size of the ring is adjusted	6 months	—
• Ability of the Cardinal ring to reduce mitral valve regurgitation	30 day	—
• 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	—

Countries

Germany, Italy

Outcome results