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

Completed · Not applicable

Conditions studied: Ventricular Tachycardia (VT)

In brief

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.

Key facts

Study ID

NCT02848781

Run by

University of Arizona

People needed

180

Starts

2015-11-30

Expected to finish

2021-03-29

Last updated by the study team

2022-12-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner University Medical Center Phoenix — Phoenix, Arizona, United States
• Fuwai Cardiovascular Hospital — Beijing, China
• Huaxi Hospital — Chengdu, China
• Guangdong General Hospital — Guangzhou, China
• Sir Run Run Shaw Hospital — Hangzhou, China
• Nanjing First Affiliated Hospital — Nanjing, China
• PLA Shenyang General Hospital — Shenyang, China
• Dokkyo Medical University, Saitama Medical Center — Saitama, Japan
• Kyorin University Hospital — Tokyo, Japan
• Tsukuba University — Tsukuba, Japan
• Korea University — Seoul, South Korea
• Taipei Veterans General Hospital — Taipei, Taiwan

Full record on ClinicalTrials.gov

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