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Completed

NCT Number: NCT01617720

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.

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SANA Herzchirurgie, Stuttgart, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. • Ability of the Cardinal ring to reduce mitral valve regurgitation

    Time frame: 30 day

  2. • Percentage of patients in whom the size of the ring is adjusted

    Time frame: 6 months

  3. • Technical feasibility of adjustment.

    Time frame: 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)

  4. • The occurrence of serious device related adverse events in all patients.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

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

Acronym: MITRAFIT

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 12, 2012
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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