Clinical trial NCT00554151: Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study
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
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Valve Regurgitation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2007-11-06
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Safety: Freedom from major adverse events (MAE)at 30 days. Performance: Technical success rate of implantation of the investigation device.
timeFrame: 30 days, 90 days, 6 months and 1 year
Secondary outcomes:
measure: 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.
timeFrame: 30 days, 90 days, 6 months and 1 year
Other outcomes:
Locations:
city: Bad Neustadt
country: Germany
facility: Herz - und Gefäß-Klinik GmbH Bad Neustadt
state: Saale
city: Leipzig
country: Germany
facility: University Leipzig
city: Milano
country: Italy
facility: Hospital San Raffaele
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
city: Rotterdam
country: Netherlands
facility: Erasmus MC, Universitair Medisch Centrum Rotterdam
Study officials:
affiliation: University Leipzig Germany
name: A. Franka Borger, Prof. MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus MC, Universitair Medisch Centrum Rotterdam
name: A.P. Kappetein, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Leids Universitair Medisch Centrum Lieden
name: R.J.M. Klautz, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Herz-und Gefäß-Klinik GmbH Bad Neustadt
name: Anno Diegeler, Prof, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital San Rafaele
name: Ottavio Alfieri, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References: