Junctional AV Ablation in CRT-D: JAVA-CRT

NCT02946853 | Completed Results DMC

• 1 other identifier: RSRB00060626
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 21

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).

Conditions

Systolic Heart Failure; Atrial Fibrillation (Permanent)

Keywords

Atrial Fibrillation; CRT; AV Junction Ablation; LVESV

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Reduction ≥ 15% in Left Ventricular End-systolic Volume (LVESV)

  Number of patients with reduction ≥ 15% in left ventricular end-systolic volume (LVESV) in each arm of the study.

  Baseline to 6 months

Secondary Outcomes (1)

• Change in Left Ventricular Ejection Fraction (EF)

  Baseline to 6 months

Other Outcomes (7)

• Percent Change in Left Ventricular End-diastolic Volume (LVEDV)

  Baseline to 6 months

• Number of Patients With Heart Failure Hospitalizations

  Baseline to 6 months

• Number of Patients With Implantable Cardioverter-defibrillator Delivered Inappropriate Therapy

  Baseline to 6 months

Study Arms (2)

CRT-D

ACTIVE COMPARATOR

Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D).

Device: Cardiac resynchronization therapy - defibrillator

CRT-D and AVJ Ablation

EXPERIMENTAL

Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation.

Procedure: Atrioventricular junctional (AVJ) ablation; Device: Cardiac resynchronization therapy - defibrillator

Interventions

Atrioventricular junctional (AVJ) ablation PROCEDURE

RF energy delivery to AV node to create complete AV block

CRT-D and AVJ Ablation

Cardiac resynchronization therapy - defibrillator DEVICE

Insertion of device capable of providing biventricular pacing and cardiac defibrillation

Also known as: CRT-D

CRT-D; CRT-D and AVJ Ablation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (21)

Arkansas Cardiology

Little Rock, Arkansas, 72205, United States

Location

Huntington Memorial Hospital

Pasadena, California, 91105, United States

Location

Emory Healthcare

Atlanta, Georgia, 30308, United States

Location

Saint Alphonsus Regional Medical Center

Boise, Idaho, 83704, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

University of Massachusetts-Worchester

Worcester, Massachusetts, 01655, United States

Location

William Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Catholic Medical Ctr/New England Heart-Vasc Inst

Manchester, New Hampshire, 03102, United States

Location

SUNY at Buffalo

Buffalo, New York, 14203, United States

Location

Northwell Hospital

New York, New York, 10075, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Portland VA Medical Center

Portland, Oregon, 97239, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19008, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19047, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

INOVA

Woodbridge, Virginia, 22191, United States

Location

Kootenai Heart Clinics, LLC

Spokane, Washington, 99204, United States

Location

Multicare Institute for Research and Innovation

Tacoma, Washington, 98405, United States

Location

Related Publications (1)

• Steinberg JS, Gorcsan J, Mazur A, Jain SK, Rashtian M, Greer GS, Zarraga I, Vloka M, Cook MM, Salam T, Mountantonakis S, Beck H, Silver J, Aktas M, Henrikson C, Schaller RD, Epstein AE, McNitt S, Schleede S, Peterson D, Goldenberg I, Zareba W. Junctional AV ablation in patients with atrial fibrillation undergoing cardiac resynchronization therapy (JAVA-CRT): results of a multicenter randomized clinical trial pilot program. J Interv Card Electrophysiol. 2022 Aug;64(2):519-530. doi: 10.1007/s10840-021-01116-6. Epub 2022 Jan 18.

  PMID: 35043250 DERIVED

MeSH Terms

Conditions

Heart Failure, Systolic; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study results were hampered by difficulty meeting the sample size targets, resulting in lower than planned power and precision. In addition, the trial did not have a study arm without any intervention (either CRT or AVJA) so that "untreated" patients could be compared to each intervention group. Hard clinical endpoints including hospitalization, death and ICD events were too infrequent to make meaningful comparisons.

Results Point of Contact

• Title: Dr. Jonathan Steinberg
• Organization: University of Rochester

jsteinberg@summithealth.com

9734364155

Study Officials

• Jonathan S Steinberg, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine - Cardiology

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: October 27, 2016
• Study Start: October 1, 2016
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: January 25, 2022
• Results First Posted: January 25, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)