Study on Safety and Performance of Medtentia Mitral Valve Repair System in Surgical Repair of Mitral Regurgitation
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The purpose of the trial is to demonstrate the safety, performance and implantability of the Medtentia Annuloplasty Ring (MAR) during mitral valve repair surgery. In addition, the trial aims to demonstrate that the MAR fulfills the requirements for mitral valve annuloplasty rings.
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Ages Eligible for Study:
18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Informed consent form signed by the subjects.
Candidate for mitral repair surgery according to European guidelines from the European Society of Cardiology (ESC)/US guideline from the American Heart Association (AHA).
Technically feasible potential candidate for MAR implantation (appropriate ring size confirmed and selected during surgery).
Life expectancy more than 24 months.
Subjects able to attend all scheduled visits and comply with all study procedures.
Any previous cardiac surgery.
Have ejection fraction below 30%
Subjects to undergo concomitant cardiac repair or replacement other than CABG, tricuspid valve repair and ablation therapy for correction of atrial fibrillation.
Have any structural hindrance that would make use of the MAR technically infeasible
Evidence of acute MI within 30 days of the intended mitral valve surgery .
History of stroke within the last 12 months or stroke that has caused major neurological dysfunction and/or significant carotid artery disease (subjects with carotid stenosis ≥50% and/or ulceration).
Recent or evolving bacterial endocarditis or subjects under antibiotic therapy.
Restricted mobility of the mitral apparatus that results in a valvular area less than 3.0 cm2.
Be in need of annular decalcification.
Have any comorbidities or conditions that would be a contraindication to open heart surgery or that would place the patient at an unacceptable surgical risk.
Subjects in whom transoesophageal ECHO/Doppler is contraindicated.
Have any recent psychiatric disorder, including drug or alcohol abuse, that in the Investigator's opinion could impair the patient's compliance with study procedures.
Be currently or have in the preceding 30 days participated in any other study involving an investigational drug or device.
Be an employee of the investigational site directly affiliated with this study, the sponsor or the clinical research organization or have an immediate family member who is.