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CompletedNCT02946853Updated Jan 25, 2022Results posted

Junctional AV Ablation in CRT-D: JAVA-CRT

An interventional study of Atrioventricular junctional (AVJ) ablation and Cardiac resynchronization therapy - defibrillator in Systolic Heart Failure and Atrial Fibrillation (Permanent), sponsored by University of Rochester. Completed at 21 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2022-01-25.

Sponsored by University of Rochester · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • Systolic Heart Failure
  • Atrial Fibrillation (Permanent)

Keywords

  • Atrial Fibrillation
  • CRT
  • AV Junction Ablation
  • LVESV
03

In context

Heart Failure, Systolic

231 studies on the registry are indexed under Heart Failure, Systolic; 50 are open to participants now.

This study's enrollment of 26 is below the median of 60 across 164 interventional studies indexed under Heart Failure, Systolic.

Browse Heart Failure, Systolic studies →

Lead sponsor

University of Rochester is the lead sponsor of 728 studies on the registry; 115 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • 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

  • Experimental
    CRT-D and AVJ Ablation

    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

  • ProcedureAtrioventricular junctional (AVJ) ablation

    RF energy delivery to AV node to create complete AV block

  • DeviceCardiac resynchronization therapy - defibrillator

    Insertion of device capable of providing biventricular pacing and cardiac defibrillation

    Also known as: CRT-D

06

What researchers measure

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.

    Time frame: Baseline to 6 months

Secondary outcomes

  1. Change in Left Ventricular Ejection Fraction (EF)

    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.

    Time frame: Baseline to 6 months

Other outcomes

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

    Percent change in left ventricular end-diastolic volume (LVEDV) by study arm.

    Time frame: Baseline to 6 months

  2. Number of Patients With Heart Failure Hospitalizations

    Number of patients with heart failure hospitalizations in each arm of the study.

    Time frame: Baseline to 6 months

  3. Number of Patients With Implantable Cardioverter-defibrillator Delivered Inappropriate Therapy

    Number of patients with implantable cardioverter-defibrillator delivered inappropriate therapy in each arm of the study

    Time frame: Baseline to 6 months

  4. Number of Patients With Implantable Cardioverter-defibrillator Delivered Appropriate Therapy for VT or VF

    Number of patients with implantable cardioverter-defibrillator delivered appropriate therapy treatment by ICD for VT/VF in each arm of the study.

    Time frame: Baseline to 6 months

  5. Percentage of Biventricular Pacing

    Amount of time that CRT is delivered

    Time frame: At 6 months

  6. Kansas City Cardiomyopathy Questionnaire

    Scoring scale from 0 to 100. Higher scores represent better quality of life.

    Time frame: Baseline and 6 months

  7. Number of Participants With Episodes of Ventricular Fibrillation Following AV Junctional Ablation as Detected on ICD

    Episodes of ventricular fibrillation following AV junctional ablation as detected on ICD in each arm of the study.

    Time frame: Baseline to one month

07

Results

Posted Jan 25, 2022
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.

Participant flow

Participant flow — Overall Study
MilestoneCRT-DCRT-D and AVJ Ablation
Started1313
Completed1213
Not completed10

Outcome measures

PrimaryNumber 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.

Time frame:
Baseline to 6 months
Reported as:
Count of participants · Participants
Number of Patients With Reduction ≥ 15% in Left Ventricular End-systolic Volume (LVESV)
ParticipantsCRT-DCRT-D and AVJ Ablation
Number of Patients With Reduction ≥ 15% in Left Ventricular End-systolic Volume (LVESV)56
Statistical analysis
  • CRT-D vs CRT-D and AVJ Ablation · Regression, Logistic · p = 1.00 · Odds ratio (or): 1.00 · 95% CI 0.14 to 7.21
SecondaryChange in Left Ventricular Ejection Fraction (EF)

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.

Time frame:
Baseline to 6 months
Reported as:
Mean · percentage
Change in Left Ventricular Ejection Fraction (EF)
percentageCRT-DCRT-D and AVJ Ablation
Change in Left Ventricular Ejection Fraction (EF)-7.0 ± 11.8-8.6 ± 9.1
Statistical analysis
  • CRT-D vs CRT-D and AVJ Ablation · Wilcoxon (Mann-Whitney) · p = 0.974 · Mean difference (net): -1.0
Other pre-specifiedPercent Change in Left Ventricular End-diastolic Volume (LVEDV)

Percent change in left ventricular end-diastolic volume (LVEDV) by study arm.

Time frame:
Baseline to 6 months
Reported as:
Mean · % change in volume
Percent Change in Left Ventricular End-diastolic Volume (LVEDV)
% change in volumeCRT-DCRT-D and AVJ Ablation
Percent Change in Left Ventricular End-diastolic Volume (LVEDV)-1.1 ± 23.7-3.5 ± 13.2
Statistical analysis
  • CRT-D vs CRT-D and AVJ Ablation · Wilcoxon (Mann-Whitney) · p = 1.00 · Mean difference (net): 0.5
Other pre-specifiedNumber of Patients With Heart Failure Hospitalizations

Number of patients with heart failure hospitalizations in each arm of the study.

Time frame:
Baseline to 6 months
Reported as:
Number · participants
Number of Patients With Heart Failure Hospitalizations
participantsCRT-DCRT-D and AVJ Ablation
Number of Patients With Heart Failure Hospitalizations11
Statistical analysis
  • CRT-D vs CRT-D and AVJ Ablation · Fisher Exact · p = 1.00 · Odds ratio (or): 1.00 · 95% CI 0.1 to 84.4
Other pre-specifiedNumber of Patients With Implantable Cardioverter-defibrillator Delivered Inappropriate Therapy

Number of patients with implantable cardioverter-defibrillator delivered inappropriate therapy in each arm of the study

Time frame:
Baseline to 6 months
Reported as:
Number · participants
Number of Patients With Implantable Cardioverter-defibrillator Delivered Inappropriate Therapy
participantsCRT-DCRT-D and AVJ Ablation
Number of Patients With Implantable Cardioverter-defibrillator Delivered Inappropriate Therapy00
Statistical analysis
  • CRT-D vs CRT-D and AVJ Ablation · Fisher Exact · p = 1.00 · Odds ratio (or): 1.00
Other pre-specifiedNumber of Patients With Implantable Cardioverter-defibrillator Delivered Appropriate Therapy for VT or VF

Number of patients with implantable cardioverter-defibrillator delivered appropriate therapy treatment by ICD for VT/VF in each arm of the study.

Time frame:
Baseline to 6 months
Reported as:
Count of participants · Participants
Number of Patients With Implantable Cardioverter-defibrillator Delivered Appropriate Therapy for VT or VF
ParticipantsCRT-DCRT-D and AVJ Ablation
Number of Patients With Implantable Cardioverter-defibrillator Delivered Appropriate Therapy for VT or VF10
Statistical analysis
  • CRT-D vs CRT-D and AVJ Ablation · Fisher Exact · p = 1.00 · Odds ratio (or): 0 · 95% CI 0.00 to 42.00
Other pre-specifiedPercentage of Biventricular Pacing

Amount of time that CRT is delivered

Time frame:
At 6 months
Reported as:
Mean · % BiV pacing
Percentage of Biventricular Pacing
% BiV pacingCRT-DCRT-D and AVJ Ablation
Percentage of Biventricular Pacing77.1 ± 26.397.7 ± 3.6
Statistical analysis
  • CRT-D vs CRT-D and AVJ Ablation · Wilcoxon (Mann-Whitney) · p = 0.005 · Mean difference (final values): 20.6
Other pre-specifiedKansas City Cardiomyopathy Questionnaire

Scoring scale from 0 to 100. Higher scores represent better quality of life.

Time frame:
Baseline and 6 months
Reported as:
Mean · score on a scale
Kansas City Cardiomyopathy Questionnaire
score on a scaleCRT-DCRT-D and AVJ Ablation
Baseline56.6 ± 17.661.9 ± 26.9
6 months69.1 ± 20.381.3 ± 18.2
Statistical analysis
  • CRT-D vs CRT-D and AVJ Ablation · Wilcoxon (Mann-Whitney) · p = 0.565 · Median difference (final values): 23.7
Other pre-specifiedNumber of Participants With Episodes of Ventricular Fibrillation Following AV Junctional Ablation as Detected on ICD

Episodes of ventricular fibrillation following AV junctional ablation as detected on ICD in each arm of the study.

Time frame:
Baseline to one month
Reported as:
Number · participants
Number of Participants With Episodes of Ventricular Fibrillation Following AV Junctional Ablation as Detected on ICD
participantsCRT-DCRT-D and AVJ Ablation
Number of Participants With Episodes of Ventricular Fibrillation Following AV Junctional Ablation as Detected on ICD10
Statistical analysis
  • CRT-D vs CRT-D and AVJ Ablation · Fisher Exact · p = 1.00 · Odds ratio (or): 0 · 95% CI 0.0 to 42.0

Adverse events

Collected over Baseline to 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CRT-D1/13 (7.7%)1/13 (7.7%)0/13 (0%)
CRT-D and AVJ Ablation0/13 (0%)1/13 (7.7%)0/13 (0%)
Most frequent serious events
Most frequent serious events
EventCRT-DCRT-D and AVJ Ablation
Hospitalization with heart failureCardiac disorders1/131/13

Baseline characteristics

Age, Continuous
Age, Continuous(years)CRT-DCRT-D and AVJ AblationTotal
Mean72 (66 to 78)73 (65 to 81)73 (65 to 81)
Sex: Female, Male
Sex: Female, Male(Participants)CRT-DCRT-D and AVJ AblationTotal
Female347
Male10919
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)CRT-DCRT-D and AVJ AblationTotal
Caucasian111324
Region of Enrollment
Region of Enrollment(participants)CRT-DCRT-D and AVJ AblationTotal
United States131326
LV End Systolic Volume
LV End Systolic Volume(cc)CRT-DCRT-D and AVJ AblationTotal
Mean115 ± 29121 ± 39118 ± 30
08

Study locations

21 sites
  • 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
09

References and documents

Publications

  • 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. PubMed 35043250 ↗

Study documents

  • Protocol and statistical analysis plan · Sep 26, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02946853
Lead sponsor
University of Rochester
Responsible party
Jonathan Steinberg (Professor of Medicine - Cardiology, University of Rochester) — Principal investigator
First posted
Oct 27, 2016
Start date
Oct 1, 2016
Primary completion
Aug 31, 2020
Completion
Aug 31, 2020
Results posted
Jan 25, 2022
Last update
Jan 25, 2022

Study contacts

Jonathan S Steinberg, MD
principal investigator · University of Rochester

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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