Clinical Evaluation of Cardiac Resynchronization Therapy With Implantable Cardioverter-defibrillator Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congestive Heart Failure (CHF)
- Sponsor
- ELA Medical, Inc.
- Status
- Approved For Marketing
- Last Updated
- 12 years ago
Overview
Brief Summary
This study provides a continued access registry for cardiac resynchronization therapy with defibrillation (CRT-D), which helps to resynchronize (coordinate) the rhythm of the heart by helping the left ventricle contract (pump blood) more uniformly, in patients with severe heart failure (New York Heart Association [NYHA] Class III or IV).
Quality of life, adverse events and device success will be analyzed and reported.
Detailed Description
ICDs have been shown to increase life expectancy substantially over various drug regimens in patients with life threatening ventricular arrhythmias. Furthermore, large scale studies of cardiac resynchronization therapy in ICD-indicated heart failure patients have demonstrated improvements in functional capacity and quality of life, without unacceptable increases in morbidity or mortality. This study provides a continued access registry for cardiac resynchronization therapy with defibrillation (CRT-D), which helps to resynchronize (coordinate) the rhythm of the heart by helping the left ventricle contract (pump blood) more uniformly, in patients with severe heart failure (NYHA Class III or IV). Quality of life, adverse events and device success will be analyzed and reported.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Accepted indication for ICD implant
- •Severe heart failure (NYHA Class III or IV) at the time of enrollment
- •May have pre-existing ICD, provided subject is on stable, optimal medical regime
- •Sinus rhythm with spontaneous QRS duration greater than or equal to 150 ms, or a QRS duration greater than or equal to 130 ms with an inter-ventricular mechanical delay (IVMD) greater than or equal to 40 ms
- •Left-ventricular ejection fraction (LVEF) of 35% or less
Exclusion Criteria
- •Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing
- •Any contraindication for ICD therapy
- •Currently implanted with a lead positioned in or through the coronary sinus
- •Hypertrophic or obstructive cardiomyopathy
- •Acute myocarditis
- •Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month
- •Recent or planned cardiac revascularization or coronary angioplasty
- •Correctable valvular disease that is the primary cause of heart failure
- •Mechanical tricuspid valve
- •Chronic atrial arrhythmia or cardioversion for atrial fibrillation within the past month, or paroxysmal atrial fibrillation requiring new pharmacologic therapy within the past month
Outcomes
Primary Outcomes
Not specified