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

NCT02848781 | Completed Results

• 1 other identifier: STUDY00000272
• Study Type: interventional
• Target: 180
• Locations: 5 countries
• Sites: 12

Brief Summary

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.

Conditions

Ventricular Tachycardia (VT)

Keywords

Sudden Cardiac Death; ICD Therapy; VT Ablation

Outcome Measures

Primary Outcomes (1)

• Freedom From Recurrent VT, Cardiovascular Rehospitalization, and All-cause Mortality

  The primary endpoint is a composite.

  2 years

Secondary Outcomes (3)

• Freedom From Recurrent VT

  2 years

• Freedom From Cardiovascular Rehospitalization

  2 years

• Freedom From All-cause Mortality

  2 years

Other Outcomes (1)

• Comparison of Outcomes in Ablation Only Registry With Randomized Patients

  2 years

Study Arms (3)

ICD with Ablation

EXPERIMENTAL

Patient will receive an implantable cardioverter defibrillator (ICD) with catheter ablation and standard medical management.

Device: Implantable Cardioverter Defibrillator (ICD); Procedure: Catheter Ablation

ICD Only

ACTIVE COMPARATOR

Patient will receive an implantable cardioverter defibrillator (ICD) and standard medical management.

Device: Implantable Cardioverter Defibrillator (ICD)

Ablation Only (Registry)

ACTIVE COMPARATOR

The registry will enroll patients who refuse an implantable cardioverter defibrillator (ICD) and are thus not randomized. This arm will assess the efficacy of catheter ablation in the absence of background ICD therapy.

Procedure: Catheter Ablation

Interventions

Implantable Cardioverter Defibrillator (ICD) DEVICE

An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.

ICD Only; ICD with Ablation

Catheter Ablation PROCEDURE

Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm.

Ablation Only (Registry); ICD with Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (12)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Fuwai Cardiovascular Hospital

Beijing, China

Location

Huaxi Hospital

Chengdu, China

Location

Guangdong General Hospital

Guangzhou, China

Location

Sir Run Run Shaw Hospital

Hangzhou, China

Location

Nanjing First Affiliated Hospital

Nanjing, China

Location

PLA Shenyang General Hospital

Shenyang, China

Location

Dokkyo Medical University, Saitama Medical Center

Saitama, Japan

Location

Kyorin University Hospital

Tokyo, Japan

Location

Tsukuba University

Tsukuba, Japan

Location

Korea University

Seoul, South Korea

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Related Publications (2)

• Tung R, Xue Y, Chen M, Jiang C, Shatz DY, Besser SA, Hu H, Chung FP, Nakahara S, Kim YH, Satomi K, Shen L, Liang E, Liao H, Gu K, Jiang R, Jiang J, Hori Y, Choi JI, Ueda A, Komatsu Y, Kazawa S, Soejima K, Chen SA, Nogami A, Yao Y; PAUSE-SCD Investigators. First-Line Catheter Ablation of Monomorphic Ventricular Tachycardia in Cardiomyopathy Concurrent With Defibrillator Implantation: The PAUSE-SCD Randomized Trial. Circulation. 2022 Jun 21;145(25):1839-1849. doi: 10.1161/CIRCULATIONAHA.122.060039. Epub 2022 May 4.

  PMID: 35507499 DERIVED

• Kheiri B, Barbarawi M, Zayed Y, Hicks M, Osman M, Rashdan L, Kyi HH, Bachuwa G, Hassan M, Stecker EC, Nazer B, Bhatt DL. Antiarrhythmic Drugs or Catheter Ablation in the Management of Ventricular Tachyarrhythmias in Patients With Implantable Cardioverter-Defibrillators: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Circ Arrhythm Electrophysiol. 2019 Nov;12(11):e007600. doi: 10.1161/CIRCEP.119.007600. Epub 2019 Nov 8.

  PMID: 31698933 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular; Death, Sudden, Cardiac

Interventions

Defibrillators, Implantable; Catheter Ablation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants; Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Rodrick Tung, MD
• Organization: College of Medicine - Phoenix

rodricktung@arizona.edu

602-521-3090

Study Officials

• Roderick Tung, MD

  University of Chicago

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: July 28, 2016
• Study Start: November 30, 2015
• Primary Completion: March 29, 2021
• Study Completion: March 29, 2021
• Last Updated: December 14, 2022
• Results First Posted: December 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6); JP (3); US (1); KR (1); TW (1)