MITRAFIT- Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)
NCT ID: NCT01617720
Last Updated: 2021-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
45 participants
OBSERVATIONAL
2012-05-31
2016-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Congenital malformations with lack of valvular tissue
* Severe valvular calcifications
* Evolving bacterial endocarditis
* Known Sensitivity to Nickel or Chromium
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Edwards Lifesciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ottavio Alfieri, Prof, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital San Raffaele, Milan, Italy
Nicolas Doll, Prof, MD
Role: PRINCIPAL_INVESTIGATOR
SANA Herzchirurgie Stuttgart , Germany
Ehud Raanani, Prof, MD
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Patrik Nataf, Prof, MD
Role: PRINCIPAL_INVESTIGATOR
Bichat Hospital, Paris, France
Volkmar Falk, Prof, MD
Role: PRINCIPAL_INVESTIGATOR
Zurich University, Zurich, Switzerland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
SANA Herzchirurgie
Stuttgart, , Germany
Hospital San Rafaele
Milan, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VC1-2
Identifier Type: -
Identifier Source: org_study_id