Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial (PAUSE-SCD)

This is an interventional treatment trial for Ventricular Tachycardia (VT) focused on measuring Sudden Cardiac Death, ICD Therapy, VT Ablation Read More

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