Junctional AV Ablation in CRT-D: JAVA-CRT

December 31, 2021 updated by: Jonathan Steinberg, University of Rochester

Junctional AV Ablation in CRT-D Patients With Atrial Fibrillation (JAVA-CRT Trial)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: CRT-D
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
Insertion of device capable of providing biventricular pacing and cardiac defibrillation
Other Names:
  • CRT-D
EXPERIMENTAL: CRT-D and AVJ Ablation
Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation.
Device: Cardiac resynchronization therapy - defibrillator
Insertion of device capable of providing biventricular pacing and cardiac defibrillation
Other Names:
  • CRT-D
Procedure: Atrioventricular junctional (AVJ) ablation
RF energy delivery to AV node to create complete AV block

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Left Ventricular Ejection Fraction (EF)
Time Frame: 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.
Baseline to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Left Ventricular End-diastolic Volume (LVEDV)
Time Frame: Baseline to 6 months
Percent change in left ventricular end-diastolic volume (LVEDV) by study arm.
Baseline to 6 months
Number of Patients With Heart Failure Hospitalizations
Time Frame: Baseline to 6 months
Number of patients with heart failure hospitalizations in each arm of the study.
Baseline to 6 months
Number of Patients With Implantable Cardioverter-defibrillator Delivered Inappropriate Therapy
Time Frame: Baseline to 6 months
Number of patients with implantable cardioverter-defibrillator delivered inappropriate therapy in each arm of the study
Baseline to 6 months
Number of Patients With Implantable Cardioverter-defibrillator Delivered Appropriate Therapy for VT or VF
Time Frame: Baseline to 6 months
Number of patients with implantable cardioverter-defibrillator delivered appropriate therapy treatment by ICD for VT/VF in each arm of the study.
Baseline to 6 months
Percentage of Biventricular Pacing
Time Frame: At 6 months
Amount of time that CRT is delivered
At 6 months
Kansas City Cardiomyopathy Questionnaire
Time Frame: Baseline and 6 months
Scoring scale from 0 to 100. Higher scores represent better quality of life.
Baseline and 6 months
Number of Participants With Episodes of Ventricular Fibrillation Following AV Junctional Ablation as Detected on ICD
Time Frame: Baseline to one month
Episodes of ventricular fibrillation following AV junctional ablation as detected on ICD in each arm of the study.
Baseline to one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ACTUAL)

August 31, 2020

Study Completion (ACTUAL)

August 31, 2020

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

October 25, 2016

First Posted (ESTIMATE)

October 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 25, 2022

Last Update Submitted That Met QC Criteria

December 31, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSRB00060626

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Systolic Heart Failure

Clinical Trials on Cardiac resynchronization therapy - defibrillator

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe