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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024264
Receipt No. 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 2017/02/03

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Basic information
Public title Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial
Acronym PAUSE-SCD
Scientific Title Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial
Scientific Title:Acronym PAUSE-SCD
Region
Japan Asia(except Japan) North America

Condition
Condition ventricular tachycardia
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 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).
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 ICD with medical management
Interventions/Control_2 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
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Roderick Tung
Organization University of Chicago
Division name Heart Rhythm Center
Zip code
Address 5758 Maryland Ave Chicago, IL, 60637
TEL +1-773-702-5988
Email rtung@bsd.uchicago.edu

Public contact
Name of contact person
1st name
Middle name
Last name Akihiko Nogami
Organization University of Tsukuba
Division name Cardiovascular Division, Faculty of Medicine
Zip code
Address 1-1-1 Tennodai, Tsukuba, 305-8575, Japan
TEL 029-853-3143
Homepage URL
Email akihiko-ind@umin.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Medtronic
Johnson & Johnson
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 03 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 02 Month 03 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 03 Day
Last modified on
2017 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027857

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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