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

Not Applicable

Recruiting

• Conditions: ventricular tachycardia

• Registration Number: JPRN-UMIN000024264
• Lead Sponsor: niversity of Tsukuba

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-03
• Study Completion: 2022-01-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

1)Any history of debilitating stroke with neurologic deficit 2)ST elevation MI or previous cardiac surgery within 60 days prior to enrollment 3)Patient is pregnant or nursing 4)Patient has chronic NYHA class IV heart failure 5)Patient has incessant VT necessitating immediate treatment 6)Patient has VT/VF thought to be from channelopathies 7)Limited life expectancy (less than one year) 8)Patient has current class IV angina 9)Recent CABG or PCI (< 45 days) 10)Patient is currently participating in another investigational drug or device study 11)Patient is unable or unwilling to cooperate with the study procedures 12)Known presence of intracardiac thrombi 13)Prosthetic mitral or aortic valve or mitral or aortic valvular heart disease requiring immediate surgical intervention 14)Major contraindication to anticoagulation therapy or coagulation disorder 15)Left Ventricular Ejection Fraction < 15% 16)Patient has had a previous ablation procedure for VT, excluding remote (> 3 months) outflow tract tachycardia 17)Patient has GFR < 30 mL/min/1.73m2 18)Patient has peripheral vascular disease that precludes LV access 19)Patient is thought to have idiopathic outflow VT as only VT 20)Patient has a PVC or VT induced cardiomyopathy that is expected to resolve with ablation and will not require an ICD 21)Patient has reversible cause of VT 22)Patient does not meet criteria for ICD or CRT-D

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint is defined as freedom from any ICD therapy, including ATP or shocks and all-cause mortality through a period of 2 years after the procedure (ablation) or randomization (standard medical therapy).