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

Sponsor

University of Arizona (Other)

Overall Status

Completed

CT.gov ID

NCT02848781

Collaborator

(none)

180

Enrollment

Locations

Arms

63.9

Actual Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Tachycardia (VT)	Device: Implantable Cardioverter Defibrillator (ICD) Procedure: Catheter Ablation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 30, 2015

Actual Primary Completion Date :

Mar 29, 2021

Actual Study Completion Date :

Mar 29, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ICD with Ablation Patient will receive an implantable cardioverter defibrillator (ICD) with catheter ablation and standard medical management.	Device: 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. Procedure: 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.
Active Comparator: ICD Only Patient will receive an implantable cardioverter defibrillator (ICD) and standard medical management.	Device: 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.
Active Comparator: 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.	Procedure: 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.

Arm

Intervention/Treatment

Experimental: ICD with Ablation

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

Device: 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.

Procedure: 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.

Active Comparator: ICD Only

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

Device: Implantable Cardioverter Defibrillator (ICD)

Active Comparator: 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.

Procedure: Catheter Ablation

Outcome Measures

Primary Outcome Measures

Freedom from recurrent VT, cardiovascular rehospitalization, and all-cause mortality [2 years]
The primary endpoint is a composite.

Secondary Outcome Measures

Freedom from recurrent VT [2 years]
Recurrent VT is defined as any appropriate ICD therapy (shock or ATP) or documented sustained monomorphic VT >30 seconds.
Freedom from cardiovascular rehospitalization [2 years]
Cardiovascular rehospitalization is defined as a hospital admission after the randomized procedure for heart failure, procedure-associated complication, or arrhythmia-related causes during the follow-up period.
Freedom from all-cause mortality [2 years]

Other Outcome Measures

Comparison of outcomes in ablation only registry with randomized patients [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banner University Medical Center Phoenix	Phoenix	Arizona	United States	85006
2	Fuwai Cardiovascular Hospital	Beijing		China
3	Huaxi Hospital	Chengdu		China
4	Guangdong General Hospital	Guangzhou		China
5	Sir Run Run Shaw Hospital	Hangzhou		China
6	Nanjing First Affiliated Hospital	Nanjing		China
7	PLA Shenyang General Hospital	Shenyang		China
8	Dokkyo Medical University, Saitama Medical Center	Saitama		Japan
9	Kyorin University Hospital	Tokyo		Japan
10	Tsukuba University	Tsukuba		Japan
11	Korea University	Seoul		Korea, Republic of
12	Taipei Veterans General Hospital	Taipei		Taiwan