Heart Failure Clinical Trial
Junctional AV Ablation in CRT-D: JAVA-CRT
Summary
Cardiac resynchronization therapy (CRT) is a demonstrably effective device intervention for patients with heart failure with reduced ejection fraction and specific indication. However, many patients with heart failure (HF) are unable to maintain sinus rhythm and approximately 30-36% of CRT patients are in atrial fibrillation (AF).
Full Description
This study is designed to evaluate if patients with AF indicated for CRT will have significant reduction in left ventricular end-systolic volume when randomized to atrioventricular junction (AVJ) ablation. In this study, subjects will be randomized to receive CRT-D or CRT-D with AVJ ablation. Randomization will be stratified by enrolling center (1:1 ratio).
Eligibility Criteria
Inclusion Criteria:
Optimal pharmacologic therapy is defined by published guidelines from the American Heart Association and the American College of Cardiology
Initial implantation of CRT-D or prior implantation of CRT-D within one year
Ischemic or nonischemic cardiomyopathy
LVEF ≤ 35%
NYHA class II-IV (ambulatory)
QRS ≥ 120 ms for LBBB and ≥ 150 ms for non-LBBB patients
Continuous AF > 3 months when no further efforts to restore sinus rhythm are feasible or pursued
Exclusion Criteria:
Ventricular rate > 110 bpm at rest despite maximal medical therapy
Ventricular rate < 50 bpm at rest
Heart block/symptomatic bradycardia that necessitates permanent pacing
Acute coronary syndrome or coronary artery bypass surgery within 12 weeks
Severe aortic or mitral valvular heart disease
Prior AVJ ablation
Any medical condition likely to limit survival to < 1 year
Patients with ACC/AHA Stage D refractory Class IV symptoms listed for transplant or requiring inotropic support
Contraindication to systematic anticoagulation
Renal failure requiring dialysis
AF due to reversible cause e.g. hyperthyroid state
Pregnancy
Participation in other clinical trials that will affect the objectives of this study
History of non-compliance to medical therapy
Inability or unwillingness to provide informed consent
Patients with short-lived AF or those in sinus rhythm are ineligible
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There are 20 Locations for this study
Little Rock Arkansas, 72205, United States
Pasadena California, 91105, United States
Atlanta Georgia, 30308, United States
Boise Idaho, 83704, United States
Iowa City Iowa, 52242, United States
Burlington Massachusetts, 01805, United States
Worcester Massachusetts, 01655, United States
Royal Oak Michigan, 48073, United States
Manchester New Hampshire, 03102, United States
Buffalo New York, 14203, United States
New York New York, 10075, United States
Rochester New York, 14642, United States
Portland Oregon, 97239, United States
Portland Oregon, 97239, United States
Abington Pennsylvania, 19008, United States
Philadelphia Pennsylvania, 19047, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15213, United States
Woodbridge Virginia, 22191, United States
Spokane Washington, 99204, United States
Tacoma Washington, 98405, United States
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