NL-OMON31130
Completed
Not Applicable
Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study - MARRS
MitralSolutions, Inc.0 sites20 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- MitralSolutions, Inc.
- Enrollment
- 20
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males or females aged \*18 to \*75 years. ;Patients with \*Grade 2\+ mitral regurgitation by pre\-operative Trans\-Thoracic Echo assessment.;Candidate for cardiopulmonary bypass. ;A Left Ventricular Ejection Fraction \*40%. ;Able and willing to comply with all study requirements, including the required study follow\-up visits. ;Able and willing to give consent and follow study instructions. ;Female patients of childbearing potential (not surgically sterilized or more than one year postmenopausal), with a negative pregnancy test (serum beta\-hCG) within 24 hours prior to mitral valve surgery.
Exclusion Criteria
- •Any previous cardiac surgery.;Any interventional cardiology procedure within six months prior to study to include all patients that have had a drug eluting stent (DES) implanted within 6 months. ;Evidence of an acute Myocardial Infarction (MI) within 7 days of the intended treatment with the investigational device.;Prior mitral valve surgery or valvuloplasty or currently implanted prosthetic valve.
- •Restricted mobility of the mitral apparatus that results in a valvular area less than 3\.0 cm2\.;Recent or evolving bacterial endocarditis or patients under current antibiotic therapy.;Patients with ICD\*s.;Any angiographic or clinical evidence that the investigator feels would place the patient at increased risk with the placement of the device or concurrent medical condition with a life expectancy of less than 12 months.;Patients who are immunocompromised or with autoimmune diseases.;Patients suffering from renal insufficiency (Creatinine \>2\.5 mg/dL) or patients with chronic renal failure undergoing dialysis.;Co\-morbid conditions that place the subject at an unacceptable surgical risk (e.g. sever chronic obstructive pulmonary disease, hepatic failure, immunosuppressive abnormalities, haematological abnormalities).;Significant mitral annular calcification.;Use of Coumadin, IIbIIIa inhibitors, Clopidigrel (Plavix) or other anti\-coagulants within (5\) five days prior to surgery. ;Participation in any study involving an investigational drug or device within the past month, or ongoing participation in a study with an investigational device.
- •Intolerance or hypersensitivity to anaesthetics.;Patients in whom transesophageal echo/Doppler is contraindicated.;History of bleeding diathesis or coagulopathy.;History of stroke within the prior 6 months.;Subjects to undergo concomitant cardiac surgical repair or replacement other than CABG (3 vessels or less) and mitral annuloplasty. Excluded concomitant procedures are: aortic valve replacement, tricuspid repair or replacement, left ventricular remodelling surgery and congenital repair.;Patients with a Euroscore \>10\.
Outcomes
Primary Outcomes
Not specified
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