Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study (MAARS)

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

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

Study Overview

• Status: Completed
• Conditions: Mitral Valve Regurgitation
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Leipzig, Germany
    • University Leipzig
  • Saale
    • Bad Neustadt, Saale, Germany, 97615
      • Herz - und Gefäß-Klinik GmbH Bad Neustadt
• Italy
  • Milano, Italy, 20132
    • Hospital San Raffaele
• Netherlands
  • Leiden, Netherlands
    • Leids Universitair Medisch Centrum
  • Rotterdam, Netherlands
    • Erasmus MC, Universitair Medisch Centrum Rotterdam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males or females aged greater or equal to 18 to less than or equal to age 75.
• 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 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 repair or replacement other than CABG (less than or equal to 3 vessels) mitral annuloplasty, tricuspid valve repair and ablation therapy for correction of atrial fibrillation. Excluded concomitant procedures are: aortic valve replacement, LV remodeling, surgery and congenital repair.
• Patients with Euroscore > 10.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety: Freedom from major adverse events (MAE)at 30 days. Performance: Technical success rate of implantation of the investigation device.	30 days, 90 days, 6 months and 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: A. Franka Borger, Prof. MD, University Leipzig Germany; Principal Investigator: A.P. Kappetein, Dr., Erasmus MC, Universitair Medisch Centrum Rotterdam; Principal Investigator: R.J.M. Klautz, Dr., Leids Universitair Medisch Centrum Lieden; Principal Investigator: Anno Diegeler, Prof, MD, Herz-und Gefäß-Klinik GmbH Bad Neustadt; Principal Investigator: Ottavio Alfieri, Prof, MD, Hospital San Rafaele

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: November 2, 2007
• First Submitted That Met QC Criteria: November 2, 2007
• First Posted (Estimate): November 6, 2007

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: MAARS CIP Version 5