Last updated on June 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ventricular tachycardia
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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