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Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study (MAARS)

Primary Purpose

Mitral Valve Regurgitation

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Adjustable Annuloplasty Ring

About this trial

This is an interventional treatment trial for Mitral Valve Regurgitation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Herz - und Gefäß-Klinik GmbH Bad Neustadt
University Leipzig
Hospital San Raffaele
Leids Universitair Medisch Centrum
Erasmus MC, Universitair Medisch Centrum Rotterdam

Outcomes

Primary Outcome Measures

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

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.

Full Information

NCT ID

NCT00554151

First Posted

November 2, 2007

Last Updated

February 1, 2019

Sponsor

Abbott Medical Devices

1. Study Identification

Unique Protocol Identification Number

NCT00554151

Brief Title

Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study

Acronym

MAARS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Abbott Medical Devices

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mitral Valve Regurgitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

55 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Adjustable Annuloplasty Ring

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Time Frame

30 days, 90 days, 6 months and 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: