Unique ID issued by UMIN | UMIN000024264 |
---|---|
Receipt number | R000027857 |
Scientific Title | Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial |
Date of disclosure of the study information | 2016/10/03 |
Last modified on | 2020/10/06 10:47:16 |
Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial
PAUSE-SCD
Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial
PAUSE-SCD
Japan | Asia(except Japan) | North America |
ventricular tachycardia
Cardiology |
Others
NO
1) To assess the incidence of sudden cardiac death and impact of ICD therapy in Asia, which has not been studied in randomized trials based in the US and Europe.
2) To explore the impact of preemptive VT ablation in patients at risk for sudden death
Efficacy
The primary efficacy endpoint is defined as freedom from any ICD therapy, including ATP or shocks and all-cause mortality through a period of 2 years after the procedure (ablation) or randomization (standard medical therapy).
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Maneuver |
ICD with medical management
ICD with catheter ablation. Main strategy is scar-based ablation with targeting of late potentials defined as low voltage potentials with fractionated, split, or delayed components
18 | years-old | <= |
Not applicable |
Male and Female
1) Patient is receiving a new ICD or 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.
2) 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 EP Study, inducible MMVT during NIPS Study.
*Inducible MMVT is defined as MMVT > 30 seconds or requiring electrical termination ( ATP or cardioversion)
3) Patient has EF < 50% or RV dysfunction
4) Patient has a cardiomyopathy with structural heart disease of any cause
5) 18 years of age or older
6) Patient has been informed of the nature of the study and has agreed to its provisions and provided written informed consent approved by the Institutional Review Board.
1) Any history of debilitating stroke with neurologic deficit
2) ST elevation MI or previous cardiac surgery within 60 days prior to enrollment
3) Patient is pregnant or nursing
4) Patient has chronic NYHA class IV heart failure
5) Patient has incessant VT necessitating immediate treatment
6) Patient has VT/VF thought to be from channelopathies
7) Limited life expectancy (less than one year)
8) Patient has current class IV angina
9) Recent CABG or PCI (< 45 days)
10) Patient is currently participating in another investigational drug or device study
11) Patient is unable or unwilling to cooperate with the study procedures
12) Known presence of intracardiac thrombi
13) Prosthetic mitral or aortic valve or mitral or aortic valvular heart disease requiring immediate surgical intervention
14) Major contraindication to anticoagulation therapy or coagulation disorder
15) Left Ventricular Ejection Fraction < 15%
16) Patient has had a previous ablation procedure for VT, excluding remote (> 3 months) outflow tract tachycardia
17) Patient has GFR < 30 mL/min/1.73m2
18) Patient has peripheral vascular disease that precludes LV access
19) Patient is thought to have idiopathic outflow VT as only VT
20) Patient has a PVC or VT induced cardiomyopathy that is expected to resolve with ablation and will not require an ICD
21) Patient has reversible cause of VT
22) Patient does not meet criteria for ICD or CRT-D
120
1st name | Roderick |
Middle name | |
Last name | Tung |
University of Chicago
Heart Rhythm Center
60637
5758 Maryland Ave Chicago, IL, 60637
+1-773-702-5988
rtung@bsd.uchicago.edu
1st name | Akihiko |
Middle name | |
Last name | Nogami |
University of Tsukuba
Cardiovascular Division, Faculty of Medicine
3058575
Faculty of Medicine
0298533143
anogami@md.tsukuba.ac.jp
University of Tsukuba
Medtronic
Johnson & Johnson
Profit organization
University of Tsukuba, Faculty of Medicine
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
029-853-3227
anogami@md.tsukuba.ac.jp
NO
2016 | Year | 10 | Month | 03 | Day |
Unpublished
Enrolling by invitation
2016 | Year | 02 | Month | 03 | Day |
2016 | Year | 10 | Month | 19 | Day |
2016 | Year | 10 | Month | 19 | Day |
2022 | Year | 01 | Month | 01 | Day |
2016 | Year | 10 | Month | 03 | Day |
2020 | Year | 10 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027857
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