Study on Safety and Performance of Medtentia Mitral Valve Repair System in Surgical Repair of Mitral Regurgitation
Study on Safety and Performance of Medtentia Mitral Valve Repair System in Surgical Repair of Mitral Regurgitation
The purpose of the trial is to demonstrate the safety and performance 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.
The purpose of this study is to evaluate the safety and performance of the MAR in patients
 with mitral regurgitation requiring either isolated mitral valve annuloplasty or mitral valve
 annuloplasty concomitantly with any of the following, either individually or in combination:

 -  Tricuspid valve repair

 -  Coronary artery bypass grafting (CABG)

 -  Valve resection and chordae repair

 -  Correction of atrial septal defect

 -  Correction of patent foramen ovale

 -  Ablation therapy for atrial defibrillation
Inclusion criteria:

 Eligible patients must meet all the following inclusion criteria:

 1. Signed Informed Consent Form.

 2. Male or female aged ≥18 to ≤ 85 years on the day of screening. Females of childbearing
 potential (not surgically sterilized or more than one year post-menopausal) must have
 a negative pregnancy test (serum beta-human chorionic gonadotropin (beta-hCG) or
 urine) within 24 hours prior to mitral valve surgery.

 3. Patient must meet one of the following indications for mitral repair surgery according
 to the European Society of Cardiology (ESC) and the American Heart Association (AHA)
 guidelines, and must have consented to have such surgery before undergoing the
 informed consent process for this study.

 -  Symptomatic patient with chronic severe primary mitral regurgitation (MR), left
 ventricle ejection fraction (LVEF) > 30% and left ventricle end systolic diameter
 (LVESD) < 55 mm or

 -  Asymptomatic patient with chronic severe primary MR who either:

 -  Has LV dysfunction (LVEF ≤ 60 % and/or LVESD ≥ 40 mm or

 -  Has a preserved LV function (LVEF> 60% and LVESD < 40 mm) together with a
 likelihood of a successful and durable repair of > 95 % and an expected
 mortality rate of < 1% or

 -  Has a flail leaflet and LVESD ≥ 40 mm together with a high likelihood of
 durable repair and a low surgical risk or

 -  Has a new onset of atrial fibrillation or pulmonary hypertension (systolic
 pulmonary pressure > 50 mm Hg at rest) or

 -  Asymptomatic patient with chronic moderate or severe primary MR who is to undergo
 cardiac surgery for another indication when the mitral valve (MV) repair can be
 performed concomitantly

 -  Patient with chronic severe or moderate secondary MR and an LVEF > 30 % who is
 undergoing CABG concomitantly

 4. Patient must have a life expectancy of more than 24 months at the time of screening,
 assuming they undergo mitral valve annuloplasty.

 5. Patient must have a mitral valve diameter corresponding to MAR size 26 - 40 and
 leaflet thickness (smallest helix height - largest helix height) for which an
 appropriate MAR ring is available.

 6. Patient must be able and willing to attend all scheduled visits and comply with all
 study procedures.

 Exclusion criteria:

 Eligible patients must not meet any of the following exclusion criteria:

 1. Have had previous cardiac surgery, including but not limited to any of the following:
 minimally invasive surgery, mitral valve surgery or valvuloplasty, implantation of a
 prosthetic heart valve or cardiac defibrillator.

 2. Have ejection fraction below 30%.

 3. Plan to have any concomitant cardiac surgery or procedure other than CABG, tricuspid
 valve repair, correction of atrial septal defect, closure of auricular appendage,
 correction of patent foramen ovale and/or ablation therapy for correction of atrial
 fibrillation performed with the mitral valve repair, which may also include leaflet
 resection and chordae replacement.

 4. Have any structural hindrance or heart abnormality that would make use of the MAR
 technically infeasible, such as a mitral valve of an unusual size or leaflet thickness
 for which a suitable MAR is not available, or an obstruction or other abnormality that
 blocks positioning of the MAR. (Final determination to be made during surgery).

 5. Show evidence of having had an acute myocardial infarction (MI) within the 30 days
 preceding the mitral valve repair surgery.

 6. Have a history of stroke within the preceding 12 months or have had any stroke that is
 not completely clinically resolved and/or significant carotid artery disease (subjects
 with carotid stenosis ≥50% and/or ulceration).

 7. Have recent or evolving bacterial endocarditis or be undergoing antibiotic therapy.

 8. Have restricted mobility of the mitral apparatus that results in a valvular area less
 than 3.0 cm2.

 9. Be in need of annular decalcification.

 10. 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, such as:
 severe chronic obstructive pulmonary disease (COPD); hepatic failure;
 immunosuppressive abnormalities or other immunological deficiencies including being
 immunocompromised or having an autoimmune disease; chronic renal failure requiring
 dialysis; hematological abnormalities including a history of bleeding diathesis or
 coagulopathy; being unable to follow the locally recommended anticoagulant regimen; an
 intolerance or hypersensitivity to anesthetics; cancer that requires further
 radiation, chemotherapy or surgical treatment.

 11. Have a contraindication to trans-esophageal echocardiography (TEE)/ Doppler.

 12. 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.

 13. Be currently or have in the preceding 30 days participated in any other study
 involving an investigational drug or device.

 14. 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.