Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study (MAARS) for Treatment of Patients With Mitral Valve Regurgitation in Open Surgical Repair

Abbott Medical Devices5 sites in 3 countries55 target enrollmentJuly 2007

ConditionsMitral Valve Regurgitation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mitral Valve Regurgitation
Sponsor: Abbott Medical Devices
Enrollment: 55
Locations: 5
Primary Endpoint: Safety: Freedom from major adverse events (MAE)at 30 days. Performance: Technical success rate of implantation of the investigation device.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Evaluation of the technical feasibility and safety of the Mitral Adjustable Annuloplasty Ring.

Detailed Description

Establish the technical feasibility and safety of implantation of the investigation device, adjustment of the investigational device post-implantation, and the ability of the investigational device to reduce mitral valve regurgitation.

Registry

clinicaltrials.gov

Start Date

July 2007

End Date

April 2010

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Eligibility Criteria

Inclusion Criteria

•Males or females aged greater or equal to 18 to less than or equal to age
•Patients with indications to undergo mitral valve repair consistent with ACC/AHA recommendations; including greater or equal to 2+ regurgitation by pre-operative TEE or TTE assessment.
•Candidate for cardiopulmonary bypass.
•A Left Ventricular Ejection Fraction greater or equal to 40%.
•Able and willing to comply with all study requirements, including the required study follow-up visits.
•Able and willing to five 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 cm
•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.

Outcomes

Primary Outcomes

Safety: Freedom from major adverse events (MAE)at 30 days. Performance: Technical success rate of implantation of the investigation device.

Time Frame: 30 days, 90 days, 6 months and 1 year

Secondary Outcomes

Ability to adjust the investigational device post-ring implantation after the patient has been weaned from CPB. MR reduction to <2+ post procedure, at post operative hospital discharge, at 30 days, at 6 months and one year.(30 days, 90 days, 6 months and 1 year)