Status
Conditions
Treatments
About
This trial is a randomized study of the MitraClip device in heart failure patients with clinically significant functional mitral regurgitation. A hierarchical composite of all-cause mortality and recurrent heart failure hospitalizations is hypothesized to occur at a lower rate with the use of the MitraClip device in addition to optimal standard medical therapy compared to optimal standard of care therapy alone.
Full description
This study is a clinical evaluation of the safety and effectiveness of the MitraClip System in the treatment of clinically significant functional mitral regurgitation in patients with chronic heart failure. The objective was to further study the safety and effectiveness of the MitraClip System for the treatment of clinically significant functional mitral regurgitation in New York Heart Association Functional Class III or IV chronic heart failure patients.
Due to lower than expected recruitment rate, Abbott Vascular sponsorship of the trial was terminated early.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Mitral regurgitation is primarily due to degenerative disease of the mitral valve apparatus (Degenerative mitral regurgitation), as determined by transesophageal echocardiography
Status 1 heart transplant or prior orthotopic heart transplantation
Introduction of a new heart failure drug class within the last 4 weeks prior to randomization
Cardiovascular hospitalization within the last 2 weeks immediately prior to randomization
Evidence of acute coronary syndrome, transient ischemic attack or stroke within 90 days prior to randomization
Any percutaneous cardiovascular intervention, carotid surgery, cardiovascular surgery or atrial fibrillation ablation within 90 days prior to randomization
Implant of any rhythm management device (i.e., pacemaker, Cardiac Resynchronization Therapy with or without cardioverter-defibrillator (CRT or CRT-D), or Implantable Cardioverter Defibrillator (ICD) within 90 days prior to randomization, or revision of any implanted rhythm management device within 90 days prior to randomization
Need for any cardiovascular surgery
Mitral valve surgery is considered a therapeutic option for the subject
Renal replacement therapy
Uncontrolled hypertension (i.e., BP >180 mmHg systolic and/or >105 mmHg diastolic) or hypotension (i.e., BP <90 mmHg systolic)
Unstable angina pectoris as judged by the investigator, other clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias
6MWT distance >450 meters
Mitral Valve Area (MVA) by planimetry <4.0 cm2; if MVA by planimetry is not measurable, pressure half-time measurement is acceptable; MVA must be confirmed by the Echocardiography Core Laboratory
Leaflet anatomy which may preclude MitraClip device implantation, proper device positioning on the leaflets, or sufficient reduction in mitral regurgitation that may include:
Presence of an IVC filter in the femoral vein that would interfere with the delivery catheter, or ipsilateral deep vein thrombosis (DVT) is present
Contraindication to transseptal catheterization
Subjects in whom transesophageal echocardiography is contraindicated
Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated)
Presence of any of the following:
Active infections requiring current antibiotic therapy
Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
Severe right ventricular failure or severe tricuspid regurgitation
History of bleeding diathesis or coagulopathy or subject who refuses blood transfusions
Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to randomization and be adherent to an accepted method of contraception
Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the investigator
Currently participating in another therapeutic or interventional heart failure trial, or in any trial of an unapproved drug or device (Subjects participating in observational studies or registries may be considered as eligible)
Subject belongs to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures
Primary purpose
Allocation
Interventional model
Masking
42 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal