None listed
Conditions
Interventions
Surgicall implanted device.
Sponsors
MitralSolutions, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Freedom from device related major adverse events (MAE) at 30 days. Performance: Technical success rate of implantation of the investigational device. | — |
Secondary
| Measure | Time frame |
|---|---|
| Performance: Ability to adjust the investigational device post-ring implantation after the patient has been weaned from CPB MR reduction post-procedure at post-operative hospital discharge, 30 days and at 90 days | — |
Countries
Netherlands
Outcome results
None listed