Junctional AV Ablation in CRT-D: JAVA-CRT

Completed · Not applicable

Conditions studied: Systolic Heart Failure, Atrial Fibrillation (Permanent)

In brief

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).

Key facts

Study ID

NCT02946853

Run by

University of Rochester

People needed

26

Starts

2016-10-01

Expected to finish

2020-08-31

Last updated by the study team

2022-01-25

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arkansas Cardiology — Little Rock, Arkansas, United States
• Huntington Memorial Hospital — Pasadena, California, United States
• Emory Healthcare — Atlanta, Georgia, United States
• Saint Alphonsus Regional Medical Center — Boise, Idaho, United States
• University of Iowa — Iowa City, Iowa, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• University of Massachusetts-Worchester — Worcester, Massachusetts, United States
• William Beaumont Hospital-Royal Oak — Royal Oak, Michigan, United States
• Catholic Medical Ctr/New England Heart-Vasc Inst — Manchester, New Hampshire, United States
• SUNY at Buffalo — Buffalo, New York, United States
• Northwell Hospital — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Portland VA Medical Center — Portland, Oregon, United States
• Abington Memorial Hospital — Abington, Pennsylvania, United States
• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• INOVA — Woodbridge, Virginia, United States
• Kootenai Heart Clinics, LLC — Spokane, Washington, United States
• Multicare Institute for Research and Innovation — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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