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

NCT ID: NCT02848781

Last Updated: 2022-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2021-03-29

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.

Detailed Description

Subjects who meet inclusion/exclusion criteria will be entered into the randomized trial. Randomization will be 1:1 between control group and ablation group. Those randomized to the control group will receive ICD therapy and routine drug therapy (including antiarrhythmic drugs as indicated). Subjects randomized to the ablation group will receive ablation therapy plus ICD for ventricular tachycardia. Patients that refuse ICD therapy and undergo ablation only will be enrolled in a prospective registry.

Follow-up will be performed prior to hospital discharge for incision check and device interrogation as is standard of care. In addition, routine device and clinical follow-up will be scheduled at 1, 3, 6, 12, 18, and 24 months. Electrocardiography (ECG) will be performed pre-implant and prior to hospital discharge. Echocardiography (TTE) will be performed pre-implant and at 12 and 24 months.

Patients that refuse ICD implantation will not be randomized and will be approached for inclusion into a registry if they undergo catheter ablation without an ICD. Basic demographics and medical history will be collected from registry subjects upon enrollment. Registry subjects will receive follow-up for routine clinical care every 6 months to check on their overall status.

120 subjects will be randomized. An additional 60 subjects will enrolled into the registry.

As of the time protocol revision C changes were made (07Nov2016), 33 subjects have been randomized. There has not been any preliminary or interim analysis of any data at this point. The study-sponsor has not had any access to any clinical follow-up for the patients enrolled to date.

Conditions

Ventricular Tachycardia (VT)

Keywords

Sudden Cardiac Death; ICD Therapy; VT Ablation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ICD with Ablation

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

Group Type: EXPERIMENTAL

Implantable Cardioverter Defibrillator (ICD)

Intervention Type: 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.

Catheter Ablation

Intervention Type: 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.

ICD Only

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

Group Type: ACTIVE_COMPARATOR

Implantable Cardioverter Defibrillator (ICD)

Intervention Type: 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.

Ablation Only (Registry)

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.

Group Type: ACTIVE_COMPARATOR

Catheter Ablation

Intervention Type: 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.

Interventions

Implantable Cardioverter Defibrillator (ICD)

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.

Intervention Type: DEVICE

Catheter Ablation

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roderick Tung, MD

Role: STUDY_DIRECTOR

University of Chicago

Locations

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

Countries

United States; China; Japan; South Korea; Taiwan

References

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.

Reference Type: DERIVED

PMID: 35507499 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31698933 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00000272

Identifier Type: -

Identifier Source: org_study_id