Systolic Heart FailureNCT02946853
Junctional AV Ablation in CRT-D: JAVA-CRT
A study testing Atrioventricular junctional (AVJ) ablation and Cardiac resynchronization therapy - defibrillator in people with Systolic Heart Failure and Atrial Fibrillation (Permanent), run by University of Rochester at 21 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Systolic Heart Failure, Atrial Fibrillation (Permanent)
- What is being tested?
- Atrioventricular junctional (AVJ) ablation and Cardiac resynchronization therapy - defibrillator
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 21 sitesUnited States
- Study dates
- 1 Oct 2016to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19008
Emory Healthcare
Atlanta, Georgia, 30308
Saint Alphonsus Regional Medical Center
Boise, Idaho, 83704
SUNY at Buffalo
Buffalo, New York, 14203
Lahey Clinic
Burlington, Massachusetts, 01805
University of Iowa
Iowa City, Iowa, 52242
Arkansas Cardiology
Little Rock, Arkansas, 72205
Catholic Medical Ctr/New England Heart-Vasc Inst
Manchester, New Hampshire, 03102
Northwell Hospital
New York, New York, 10075
Huntington Memorial Hospital
Pasadena, California, 91105
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19047
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Oregon Health & Science University
Portland, Oregon, 97239
Portland VA Medical Center
Portland, Oregon, 97239
University of Rochester Medical Center
Rochester, New York, 14642
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073
Kootenai Heart Clinics, LLC
Spokane, Washington, 99204
Multicare Institute for Research and Innovation
Tacoma, Washington, 98405
INOVA
Woodbridge, Virginia, 22191
University of Massachusetts-Worchester
Worcester, Massachusetts, 01655
About this study
Official title: 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).
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).
- Being tested
- Atrioventricular junctional (AVJ) ablation, Cardiac resynchronization therapy - defibrillator
- Keywords
- Atrial Fibrillation, CRT, AV Junction Ablation, LVESV
- Medical subject headings
- Heart Failure, Systolic, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrioventricular junctional (AVJ) ablationProcedure or surgery
RF energy delivery to AV node to create complete AV block
Cardiac resynchronization therapy - defibrillatorDevice
Also called CRT-D
Insertion of device capable of providing biventricular pacing and cardiac defibrillation
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: Atrioventricular junctional (AVJ) ablation; Device: Cardiac resynchronization therapy - defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study start1 Oct 2016
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systolic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Steinberg, University of Rochester
- Investigators
- Jonathan S Steinberg, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946853
- Sponsor's protocol ID
- RSRB00060626
- Status last verified
- Dec 2021
- First submitted
- 24 Oct 2016
- Last updated
- 25 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Junctional AV Ablation in CRT-D Patients With Atrial Fibrillation (JAVA-CRT Trial)
- ClinicalTrials.gov ID
- NCT02946853
- Acronym / sponsor ID
- RSRB00060626
- Keywords
- Atrial Fibrillation, CRT, AV Junction Ablation, LVESV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Posted 25 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT-D | Active comparator | Device: Cardiac resynchronization therapy - defibrillatorPatients 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 | Experimental | Procedure: Atrioventricular junctional (AVJ) ablation, Device: Cardiac resynchronization therapy - defibrillatorPatients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atrioventricular junctional (AVJ) ablationRF energy delivery to AV node to create complete AV block | Procedure or surgery | CRT-D and AVJ Ablation |
| Cardiac resynchronization therapy - defibrillatorAlso: CRT-DInsertion of device capable of providing biventricular pacing and cardiac defibrillation | Device | CRT-D, CRT-D and AVJ Ablation |
Primary outcome
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.
1 secondary outcome
Change in Left Ventricular Ejection Fraction (EF)
Time frame: Baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35043250Steinberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan S Steinberg, MD principal investigator
University of Rochester
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atrioventricular junctional (AVJ) ablation and Cardiac resynchronization therapy - defibrillator in people with Systolic Heart Failure and Atrial Fibrillation (Permanent), run by University of Rochester at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Reduction ≥ 15% in Left Ventricular End-systolic Volume (LVESV) (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02946853, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.