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).

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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).

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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

Study is for people with:

Heart Failure

Estimated Enrollment:

26

Study ID:

NCT02946853

Recruitment Status:

Completed

Sponsor:

University of Rochester

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There are 20 Locations for this study

See Locations Near You

Arkansas Cardiology
Little Rock Arkansas, 72205, United States
Huntington Memorial Hospital
Pasadena California, 91105, United States
Emory Healthcare
Atlanta Georgia, 30308, United States
Saint Alphonsus Regional Medical Center
Boise Idaho, 83704, United States
University of Iowa
Iowa City Iowa, 52242, United States
Lahey Clinic
Burlington Massachusetts, 01805, United States
University of Massachusetts-Worchester
Worcester Massachusetts, 01655, United States
William Beaumont Hospital-Royal Oak
Royal Oak Michigan, 48073, United States
Catholic Medical Ctr/New England Heart-Vasc Inst
Manchester New Hampshire, 03102, United States
SUNY at Buffalo
Buffalo New York, 14203, United States
Northwell Hospital
New York New York, 10075, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
Portland VA Medical Center
Portland Oregon, 97239, United States
Abington Memorial Hospital
Abington Pennsylvania, 19008, United States
Drexel University College of Medicine
Philadelphia Pennsylvania, 19047, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15213, United States
INOVA
Woodbridge Virginia, 22191, United States
Kootenai Heart Clinics, LLC
Spokane Washington, 99204, United States
Multicare Institute for Research and Innovation
Tacoma Washington, 98405, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

26

Study ID:

NCT02946853

Recruitment Status:

Completed

Sponsor:


University of Rochester

How clear is this clinincal trial information?

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