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

General Information

Age Group

Adult

Status

Active

Protocol Number

17-2757

Background Information

CRT-D helps coordinate the pumping action of your heart. When it works well, it can improve heart function, lessen heart failure symptoms, prevent hospitalization and decrease the risk of death. If CRT-D is partially or completely ineffective, the heart function may continue to deteriorate and lead to “heart failure” sumptoms. Atrial fibrillation may interfere with how well the CRT-D device works.

Atrial fibrillation (AF) is usually treated with medicines to try to slow down the fast and irregular heart rates associated with AF. The medicines used to accomplish this are known as beta-blockers and digozin. Other medicines that can help are called calcium blockers but they should not be used in patients with heart failure. The precise degree of slowing that is needed to optimize CRT-D is uncertain when atrial fibrillation is prese3nt, but medications may not always achieve this. The alternative is atriventricular jucntional (AVJ) ablation which permanently and effectively slows the heartbeat and eliminates the need to use the medications foot this purpose.

The purpose of this study is to test whether doing a procedure, called atriventricular junctional (AVJ) ablation, can improve the response of CRT-D in patients with atrial fibrillation. AVJ ablation is a procedure which will help to slow down your heart rhythm. This ablation disables the electrical system that connects the upper and lower chambers of the heart so rapid impulses that are characteristic of atrial fibrillation cannot be transmitted to the pumping chambers, a scenario that can interfere with proper delivery of CRT-D.

This study will compare two ways of approaching CRT-D treatmen tin patients who have atrial fibrillation.  If you are found t be eligible and agree to participate in this study, you will be randomly assigned to receive one of the following two treatments:

1. CRT-D device implantation or
2. CRT-D device implantation and AVJ ablation procedure of the elctrical pathway that transmits electricla signal between atria and ventricles to control your atrial fibrillation

JAVA-CRT trial is proposed as an unblinded randomized controlled longitudinal trial. At randomization subjects receiving CRT-D implantation for standard clinicla indications will be randomized 1:1 to undergo AVJ ablation or to be treated conventially without AVJ ablation. Subjects will be required to be on optimal medical therapy including maximally tolerated doses of beta-blockers and digoxin will be used for rate control of ventricular response. AVJ ablation will be performed at the time of CRT-D implantation. Programming of implantable devices will be by protocol and will intend to provide maximal CRT pacing with attention to rate cutoffs an denhanced features. Subjects will be excluded from the trial if ventricular rates at rest are >90 bpm despite optimal medical therapy or <50 bpm, or if they have heart block or symptomatic bradycardia that necessitates permanent pacing.

Offered At

Inova Center for Thrombosis Research and Drug Development
Inova Heart and Vascular Institute
3300 Gallows Road
Falls Church, VA 22042

Eligibility Information

  • Age > = 21 years on date of consent
  • Optimal pharmacologic therapy is defined by published guidelines from the American Heart Association and the American College of Cardiology
  • Existing infdication for CRT device with initial implant scheduled within 1 calendar month on or from date of randomization
  • Ischemic or nonischemic cardiomyopathy
  • LVEF<= 35% withink 12 calendar months prior to or on consent date by angiographic, radionuclide, or echocardiographic methods
  • NYHA class II-IV (ambulatory) on consent date
  • QRS >= 120 ms for LBBB and >= 150 ms for non-LBB patients within 1 calendar year prior to or on consent date
  • Continuous AF > 6 months when no further efforts to restore sinus rhythm are feasible or pursued

Ineligibility Information

  • Ventricular rate > 90 bpm at rest despite maximal medical therapy evidenced on 12-lead ECG within 1 calendar year prior to or on consent date
  • Ventricular rate < 50 bpm at rest evidenced on 12-;ead ECG within 1 calendar year prior to or on consent date
  • Heart block/symptomatic bradycardia that necessitates permanent pacing
  • Acute coronary syndrome or coronary artery bypass surgery or percutaneous coronaryartery bypass surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past 3 calendar months prior to consent
  • Enzyme-positive myocardial infarction within the past 3 calendar months prior to consent
  • Severe aortic or mitral valvular heart disease eligible for percutaneous or surgical repair/replacement procedures
  • Angiographic evidence of coronary disease that requires coronary revascularization and with likelihood of undergoing a CABG or PCIU in the next 3 calendar months following consent date
  • Prior surgical or percutaneous AF ablation procedure any time in the past
  • Prior AVJ ablation any time in the past
  • Any medical condition oikely to limit survival to < 1 year
  • Presence of ACC/AHA Stage D refractory Class IV symptoms listed for transplant or requiring inotropic support at time of consent
  • Contraindication to systematic anticoagulation
  • Renal failure requiring dialysis at time of consent
  • AF due to reversible cause e.g. hyperthroid state
  • Women who are pregnant or plan to become pregnant during the course of the trial - Note: Women of childbearing potential must have a negative pregnancy test within 7 days prior to randomization
  • Participation in other clinicla trials that will affect the objectives of this study
  • History of non-compliance to medical therapy
  • Participation in other clinical trials (observational/lead registries are allowed) with approval from the CDC
  • Inability or unwillingness to provide informed consent
  • Resides at such a distance from the enrolling site so travel to follow-up visits would be unusually difficult
  • Does not anticipate residing in the vicinity of the enrolling site for the duration of the trial
  • Short-lived AF or in sinus rhythm