Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial

  • STATUS
    Recruiting
  • End date
    Feb 22, 2023
  • participants needed
    180
  • sponsor
    University of Chicago
Updated on 22 January 2021
Investigator
Roderick Tung, MD
Primary Contact
Dokkyo Medical University, Saitama Medical Center (9.6 mi away) Contact
+10 other location

Summary

The current standard of care for ventricular tachycardia (VT) includes the use of medicine called anti-arrhythmic drugs (AADs) and Implantable Cardioverter Defibrillator (ICD) therapy. These treatments are used to terminate the irregular heartbeats and bring the heart back to a normal rhythm. Catheter ablation is a procedure used to eliminate (damage) the heart cells causing the arrhythmia. Patients eligible for this may benefit from an ablation procedure in addition to an ICD to treat their VT condition or risk of developing VT. This study aims to show that treating VT with catheter ablation, if performed preemptively at the time of ICD implantation, will reduce subsequent recurrent VT, ICD shocks, and lead to improved survival.

Description

Subjects who meet inclusion/exclusion criteria will be entered into the randomized trial. Randomization will be 1:1 between control group and ablation group. Those randomized to the control group will receive ICD therapy and routine drug therapy (including antiarrhythmic drugs as indicated). Subjects randomized to the ablation group will receive ablation therapy plus ICD for ventricular tachycardia. Patients that refuse ICD therapy and undergo ablation only will be enrolled in a prospective registry.

Follow-up will be performed prior to hospital discharge for incision check and device interrogation as is standard of care. In addition, routine device and clinical follow-up will be scheduled at 1, 3, 6, 12, 18, and 24 months. Electrocardiography (ECG) will be performed pre-implant and prior to hospital discharge. Echocardiography (TTE) will be performed pre-implant and at 12 and 24 months.

Patients that refuse ICD implantation will not be randomized and will be approached for inclusion into a registry if they undergo catheter ablation without an ICD. Basic demographics and medical history will be collected from registry subjects upon enrollment. Registry subjects will receive follow-up for routine clinical care every 6 months to check on their overall status.

120 subjects will be randomized. An additional 60 subjects will enrolled into the registry.

As of the time protocol revision C changes were made (07Nov2016), 33 subjects have been randomized. There has not been any preliminary or interim analysis of any data at this point. The study-sponsor has not had any access to any clinical follow-up for the patients enrolled to date.

Details
Condition Tachycardia, Ventricular tachycardia, Fast Heart Rate (Tachycardia)
Treatment catheter ablation, Implantable Cardioverter Defibrillator (ICD)
Clinical Study IdentifierNCT02848781
SponsorUniversity of Chicago
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient is receiving a new implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy device (CRT-D) implant that has study required programing capabilities and is appropriate for remote monitoring. Patient who has received the ICD / CRT-D within 90 days of enrollment can also be enrolled
Patient who has a high risk of ICD shock as shown by documented Monomorphic VT (MMVT) by one or more of the following
Spontaneous MMVT
Inducible MMVT during electrophysiology study
Inducible MMVT during noninvasive programmed stimulation study Inducible MMVT is defined as MMVT > 30 seconds or requiring electrical termination (ATP or cardioversion)
Patient has ejection fraction < 50% or right ventricular dysfunction
Patient has a cardiomyopathy with structural heart disease of any cause

Exclusion Criteria

Any history of debilitating stroke with neurologic deficit
ST-segment elevation myocardial infarction or previous cardiac surgery within 60 days prior to enrollment
Patient is pregnant or nursing
Patient has chronic New York Heart Association (NYHA) class IV heart failure
Patient has incessant VT necessitating immediate treatment
Patient has ventricular tachycardia/ventricular fibrillation thought to be from channelopathies
Limited life expectancy (less than one year)
Patient has current class IV angina
Recent coronary artery bypass graft or percutaneous coronary intervention (< 45 days)
Patient is currently participating in another investigational drug or device study
Known presence of intracardiac thrombi
Prosthetic mitral or aortic valve or mitral or aortic valvular heart disease requiring immediate surgical intervention
Major contraindication to anticoagulation therapy or coagulation disorder
Left Ventricular Ejection Fraction < 15%
Patient has had a previous ablation procedure for VT, excluding remote (> 3 months) outflow tract tachycardia
Patient has glomerular filtration rate (GFR) < 30 mL/min/1.73m2
Patient has peripheral vascular disease that precludes left ventricular access
Patient is thought to have idiopathic outflow VT as only VT
Patient has a premature ventricular contraction (PVC) or VT induced cardiomyopathy that is expected to resolve with ablation and will not require an ICD
Patient has reversible cause of VT
Patient does not meet criteria for ICD or CRT-D
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