Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study

NCT00554151 | Completed DMC

• 1 other identifier: MAARS CIP Version 5
• Study Type: interventional
• Target: 55
• Locations: 3 countries
• Sites: 5

Brief Summary

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

Conditions

Mitral Valve Regurgitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

Adjustable Annuloplasty Ring DEVICE

The investigational device is intended for use in the treatment of mitral valve regurgitation.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (5)

Herz - und Gefäß-Klinik GmbH Bad Neustadt

Bad Neustadt an der Saale, Saale, 97615, Germany

Location

University Leipzig

Leipzig, Germany

Location

Hospital San Raffaele

Milan, 20132, Italy

Location

Leids Universitair Medisch Centrum

Leiden, Netherlands

Location

Erasmus MC, Universitair Medisch Centrum Rotterdam

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 2007
• First Posted: November 6, 2007
• Study Start: July 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2010
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

NL (2); DE (2); IT (1)