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

Ventricular Tachycardia (VT) Clinical Trial

— PAUSE-SCD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02848781
• Other study ID #: STUDY00000272
• Status: Completed
• Phase: N/A
• Start date: November 30, 2015
• Est. completion date: March 29, 2021

Study information

• Verified date: March 2022
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 29, 2021
• Est. primary completion date: March 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia (VT)

Intervention

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.

Locations

Country	Name	City	State
China	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
Japan	Dokkyo Medical University, Saitama Medical Center	Saitama
Japan	Kyorin University Hospital	Tokyo
Japan	Tsukuba University	Tsukuba
Korea, Republic of	Korea University	Seoul
Taiwan	Taipei Veterans General Hospital	Taipei
United States	Banner University Medical Center Phoenix	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Countries where clinical trial is conducted

United States,  China,  Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of Outcomes in Ablation Only Registry With Randomized Patients		2 years
Primary	Freedom From Recurrent VT, Cardiovascular Rehospitalization, and All-cause Mortality	The primary endpoint is a composite.	2 years
Secondary	Freedom From Recurrent VT	Recurrent VT is defined as any appropriate ICD therapy (shock or ATP) or documented sustained monomorphic VT >30 seconds.	2 years
Secondary	Freedom From Cardiovascular Rehospitalization	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.	2 years
Secondary	Freedom From All-cause Mortality		2 years