UMIN-CTR Clinical Trial
| 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 | 2024/10/09 17:25:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Roderick |
| Middle name | |
| Last name | Tung |
Organization
University of Chicago
Division name
Heart Rhythm Center
Zip code
60637
Address
5758 Maryland Ave Chicago, IL, 60637
TEL
+1-773-702-5988
rtung@bsd.uchicago.edu
Public contact
Name of contact person
| 1st name | Akihiko |
| Middle name | |
| Last name | Nogami |
Organization
University of Tsukuba
Division name
Cardiovascular Division, Faculty of Medicine
Zip code
3058575
Address
Faculty of Medicine
TEL
0298533143
Homepage URL
anogami@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
University of Tsukuba, Faculty of Medicine
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel
029-853-3227
anogami@md.tsukuba.ac.jp
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
https://www.clinicaltrials.gov; Unique identifier: NCT02848781.
Publication of results
Published
Result
URL related to results and publications
https://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.122.060039?rfr_dat=cr_pub++0pubmed&url_v
Number of participants that the trial has enrolled
180
Results
Among patients with cardiomyopathy of varied causes, early catheter ablation performed at the time of ICD implantation significantly reduced the composite primary outcome of VT recurrence, cardiovascular hospitalization, or death. These findings were driven by a reduction in ICD therapies.
Results date posted
| 2024 | Year | 10 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 05 | Month | 04 | Day |
Baseline Characteristics
We conducted an international, multicenter, randomized controlled trial enrolling 180 patients with cardiomyopathy and monomorphic VT with an indication for ICD implantation to assess the role of early, first-line ablation therapy. A total of 121 patients were randomly assigned (1:1) to ablation plus an ICD versus conventional medical therapy plus an ICD. Patients who refused ICD (n=47) were followed in a prospective registry after stand-alone ablation treatment. The primary outcome was a composite end point of VT recurrence, cardiovascular hospitalization, or death.
Participant flow
Randomly assigned patients had a mean age of 55 years (interquartile range, 46?64) and left ventricular ejection fraction of 40% (interquartile range, 30%?49%); 81% were male. The underlying heart disease was ischemic cardiomyopathy in 35%, nonischemic cardiomyopathy in 30%, and arrhythmogenic cardiomyopathy in 35%. Ablation was performed a median of 2 days before ICD implantation (interquartile range, 5 days before to 14 days after). At 31 months, the primary outcome occurred in 49.3% of the ablation group and 65.5% in the control group (hazard ratio, 0.58 [95% CI, 0.35?0.96]; P=0.04). The observed difference was driven by a reduction in VT recurrence in the ablation arm (hazard ratio, 0.51 [95%CI, 0.29?0.90]; P=0.02). A statistically significant reduction in both ICD shocks (10.0% versus 24.6%; P=0.03) and antitachycardia pacing (16.2% versus 32.8%; P=0.04) was observed in patients who underwent ablation compared with control. No differences in cardiovascular hospitalization (32.0% versus. 33.7%; hazard ratio, 0.82 [95% CI, 0.43?1.56]; P=0.55) or mortality (8.9% versus 8.8%; hazard ratio, 1.40 [95% CI, 0.38?5.22]; P=0.62]) were observed. Ablation-related complications occurred in 8.3% of patients.
Adverse events
Adverse Events
There were 5 (8.3%) procedural-related complications in the ablation group: 2 patients who underwent a retrograde approach sustained a type B aortic dissection (managed conservatively) and aortic leaflet prolapse (requiring surgical repair). A right ventricular puncture without sequelae occurred during epicardial access in 1 patient, and another patient had a left ventricular perforation during ablation that was managed with a pericardial drain and transfusion. Last, a delayed pericardial effusion, 47 days after ablation, occurred in 1 patient.
Outcome measures
Randomly assigned patients had a mean age of 55 years (interquartile range, 46?64) and left ventricular ejection fraction of 40% (interquartile range, 30%?49%); 81% were male. The underlying heart disease was ischemic cardiomyopathy in 35%, nonischemic cardiomyopathy in 30%, and arrhythmogenic cardiomyopathy in 35%. Ablation was performed a median of 2 days before ICD implantation (interquartile range, 5 days before to 14 days after). At 31 months, the primary outcome occurred in 49.3% of the ablation group and 65.5% in the control group (hazard ratio, 0.58 [95% CI, 0.35?0.96]; P=0.04). The observed difference was driven by a reduction in VT recurrence in the ablation arm (hazard ratio, 0.51 [95%CI, 0.29?0.90]; P=0.02). A statistically significant reduction in both ICD shocks (10.0% versus 24.6%; P=0.03) and antitachycardia pacing (16.2% versus 32.8%; P=0.04) was observed in patients who underwent ablation compared with control. No differences in cardiovascular hospitalization (32.0% versus. 33.7%; hazard ratio, 0.82 [95% CI, 0.43?1.56]; P=0.55) or mortality (8.9% versus 8.8%; hazard ratio, 1.40 [95% CI, 0.38?5.22]; P=0.62]) were observed. Ablation-related complications occurred in 8.3% of patients.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 01 | Day |
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
| 2024 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027857
