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