Clinical trial NCT02848781: Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial
Official title: PAUSE-SCD: Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia (VT)
Keywords: Sudden Cardiac Death
ICD Therapy
VT Ablation
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Freedom From Recurrent VT, Cardiovascular Rehospitalization, and All-cause Mortality
timeFrame: 2 years
Secondary outcomes:
measure: Freedom From Recurrent VT
timeFrame: 2 years
measure: Freedom From Cardiovascular Rehospitalization
timeFrame: 2 years
measure: Freedom From All-cause Mortality
timeFrame: 2 years
Other outcomes:
measure: Comparison of Outcomes in Ablation Only Registry With Randomized Patients
timeFrame: 2 years
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center Phoenix
state: Arizona
city: Beijing
country: China
facility: Fuwai Cardiovascular Hospital
city: Chengdu
country: China
facility: Huaxi Hospital
city: Guangzhou
country: China
facility: Guangdong General Hospital
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
city: Nanjing
country: China
facility: Nanjing First Affiliated Hospital
city: Shenyang
country: China
facility: PLA Shenyang General Hospital
city: Saitama
country: Japan
facility: Dokkyo Medical University, Saitama Medical Center
city: Tokyo
country: Japan
facility: Kyorin University Hospital
city: Tsukuba
country: Japan
facility: Tsukuba University
city: Seoul
country: Korea, Republic of
facility: Korea University
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: University of Chicago
name: Roderick Tung, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.