UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063253 |
|---|---|
| Receipt number | R000072399 |
| Scientific Title | Long-term Follow-up Study of SUPPRESS-AF: Efficacy and Safety of Low-voltage Guided Ablation for Recurrence Prevention Compared to Pulmonary Vein Isolation Alone in Patients with Persistent Atrial Fibrillation |
| Date of disclosure of the study information | 2026/10/14 |
| Last modified on | 2026/10/13 12:24:51 |
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Basic information
Public title
Long-term Follow-up Study of SUPPRESS-AF: Efficacy and Safety of Low-voltage Guided Ablation for Recurrence Prevention Compared to Pulmonary Vein Isolation Alone in Patients with Persistent Atrial Fibrillation
Acronym
SUPPRESS AF Long-term Follow-up Study
Scientific Title
Long-term Follow-up Study of SUPPRESS-AF: Efficacy and Safety of Low-voltage Guided Ablation for Recurrence Prevention Compared to Pulmonary Vein Isolation Alone in Patients with Persistent Atrial Fibrillation
Scientific Title:Acronym
SUPPRESS AF Long-term Follow-up Study
Region
| Japan |
Condition
Condition
Persistent atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the long-term effects of catheter ablation targeting left atrial low-voltage areas in addition to pulmonary vein isolation on atrial fibrillation recurrence and clinical outcomes in patients with persistent atrial fibrillation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Three-year recurrence rate of atrial fibrillation following the first catheter ablation procedure among 341 patients with left atrial low-voltage areas.
Key secondary outcomes
Five-year incidence of all-cause mortality, hospitalization for heart failure, symptomatic ischemic stroke, and bleeding events following the first catheter ablation procedure in the overall cohort, as well as the five-year recurrence rate of atrial fibrillation following the first catheter ablation procedure among 341 patients with left atrial low-voltage areas.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients enrolled in the SUPPRESS-AF study who underwent their first catheter ablation for persistent atrial fibrillation and were eligible for participation in the long-term follow-up study under the ethics committee-approved consent procedures.
Key exclusion criteria
No additional exclusion criteria are specified for this long-term follow-up study.
Target sample size
1347
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Sakata |
Organization
The University of Osaka Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka
TEL
06-6879-3640
yasushisk@cardiology.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Sotomi |
Organization
The University of Osaka Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka
TEL
06-6879-3640
Homepage URL
yohei.sotomi@cardiology.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, The University of Osaka Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Johnson and 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
Osaka University Research Review Committee
Address
Yamadaoka 2-2, Suita, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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
大阪大学医学部附属病院（大阪府）、大阪警察病院（大阪府）、大阪急性期・総合医療センター（大阪府）、大阪労災病院（大阪府）、関西労災病院（兵庫県）、桜橋渡辺未来医療病院（大阪府）、八尾市立病院（大阪府）、大阪医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 14 | 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
| 2026 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a long-term observational follow-up study of patients enrolled in SUPPRESS-AF, a multicenter randomized controlled trial.
Management information
Registered date
| 2026 | Year | 10 | Month | 13 | Day |
Last modified on
| 2026 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072399
