Junctional AV Ablation in CRT-D: JAVA-CRT

Not Applicable

Completed

• Conditions: Atrial Fibrillation (Permanent); Systolic Heart Failure
• Interventions: Device: Cardiac resynchronization therapy - defibrillator; Procedure: Atrioventricular junctional (AVJ) ablation

• Registration Number: NCT02946853
• Lead Sponsor: University of Rochester

Brief 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).

Detailed 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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-27
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Results First Submitted: 2021-07-20
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-31
• Last Update Submitted: 2021-12-31
• Results First Posted: 2022-01-25
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRT-D	Cardiac resynchronization therapy - defibrillator	Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D).
CRT-D and AVJ Ablation	Atrioventricular junctional (AVJ) ablation	Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation.
CRT-D and AVJ Ablation	Cardiac resynchronization therapy - defibrillator	Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Reduction ≥ 15% in Left Ventricular End-systolic Volume (LVESV)	Baseline to 6 months	Number of patients with reduction ≥ 15% in left ventricular end-systolic volume (LVESV) in each arm of the study.

Secondary Outcome Measures

Name	Time	Method
Change in Left Ventricular Ejection Fraction (EF)	Baseline to 6 months	Change in left ventricular ejection fraction from baseline to 6 months. Units are expressed in percent and change may vary from -20% to 20%. More negative numbers are desired representing improvement from baseline to 6 months.

Trial Locations

Locations (21)

Arkansas Cardiology; 🇺🇸 Little Rock, Arkansas, United States

Huntington Memorial Hospital; 🇺🇸 Pasadena, California, United States

SUNY at Buffalo; 🇺🇸 Buffalo, New York, United States

Emory Healthcare; 🇺🇸 Atlanta, Georgia, United States

University of Massachusetts-Worchester; 🇺🇸 Worcester, Massachusetts, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

Portland VA Medical Center; 🇺🇸 Portland, Oregon, United States

Multicare Institute for Research and Innovation; 🇺🇸 Tacoma, Washington, United States

Drexel University College of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States

Kootenai Heart Clinics, LLC; 🇺🇸 Spokane, Washington, United States

Northwell Hospital; 🇺🇸 New York, New York, United States

Abington Memorial Hospital; 🇺🇸 Abington, Pennsylvania, United States

Lahey Clinic; 🇺🇸 Burlington, Massachusetts, United States

Saint Alphonsus Regional Medical Center; 🇺🇸 Boise, Idaho, 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

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

INOVA; 🇺🇸 Woodbridge, Virginia, United States