Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study

Not Applicable

Completed

• Conditions: Mitral Valve Regurgitation

• Registration Number: NCT00554151
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-11-02
• Study First Submitted QC: 2007-11-02
• Study First Posted: 2007-11-06
• Primary Completion: 2009-03
• Study Completion: 2010-04
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (5)

University Leipzig; 🇩🇪 Leipzig, Germany

Leids Universitair Medisch Centrum; 🇳🇱 Leiden, Netherlands

Herz - und Gefäß-Klinik GmbH Bad Neustadt; 🇩🇪 Bad Neustadt, Saale, Germany

Hospital San Raffaele; 🇮🇹 Milano, Italy

Erasmus MC, Universitair Medisch Centrum Rotterdam; 🇳🇱 Rotterdam, Netherlands