Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study (MAARS)

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00554151
First received: November 2, 2007
Last updated: June 20, 2011
Last verified: February 2010
  Purpose

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


Condition Intervention
Mitral Valve Regurgitation
Device: Adjustable Annuloplasty Ring

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study (MAARS) for Treatment of Patients With Mitral Valve Regurgitation in Open Surgical Repair

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 30 days, 90 days, 6 months and 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 55
Study Start Date: July 2007
Study Completion Date: April 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Adjustable Annuloplasty Ring
    The investigational device is intended for use in the treatment of mitral valve regurgitation.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554151

Locations
Germany
Herz - und Gefäß-Klinik GmbH Bad Neustadt
Bad Neustadt, Saale, Germany, 97615
University Leipzig
Leipzig, Germany
Italy
Hospital San Raffaele
Milano, Italy, 20132
Netherlands
Leids Universitair Medisch Centrum
Leiden, Netherlands
Erasmus MC, Universitair Medisch Centrum Rotterdam
Rotterdam, Netherlands
Sponsors and Collaborators
St. Jude Medical
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
  More Information

No publications provided

Responsible Party: Vicki Bebeau, St. Jude Medical, Inc.
ClinicalTrials.gov Identifier: NCT00554151     History of Changes
Other Study ID Numbers: MAARS CIP Version 5
Study First Received: November 2, 2007
Last Updated: June 20, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: Ethics Commission

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014