UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035940 |
|---|---|
| Receipt number | R000038895 |
| Scientific Title | 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 | 2019/04/01 |
| Last modified on | 2024/10/11 16:00:51 |
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Basic information
Public title
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
Scientific Title
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
Region
| Japan |
Condition
Condition
Persistent atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness and safety of catheter ablation to the left atrial low potential area added to pulmonary venous isolation in patients with persistent atrial fibrillation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
One-year recurrence rate of atrial fibrillation following the first session of catheter ablation
Key secondary outcomes
Atrial fibrillation recurrence rate after the last ablation
Death (cause of death)
Symptomatic cerebral infarction
Ablation-related complications
Hemorrhagic complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Group A: Pulmonary vein isolation
Interventions/Control_2
Group B: Pulmonary vein isolation with low voltage area ablation
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 with initial ablation for persistent atrial fibrillation and left atrial low voltage area
Key exclusion criteria
Left atrial diameter 55 mm or more
History of cardiac surgery
Valvular atrial fibrillation
Maintenance dialysis
Contraindication of ablation
Contraindication of anticoagulation therapy
Stroke, transient cerebral ischemic attack, systemic embolism in the past 6 months
Atrial fibrillation due to treatable factors
Pregnancy or possible pregnancy
Other cases the doctor considers inappropriate
Target sample size
340
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Sakata |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka
TEL
06-6879-3631
yasushisk@cardiology.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shungo |
| Middle name | |
| Last name | Hikoso |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka
TEL
06-6879-3631
Homepage URL
hikoso@cardiology.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Osaka University 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
0662108289
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）、特定医療法人渡辺医学会桜橋渡辺病院（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
| 2019 | Year | 04 | Month | 01 | 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
340
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
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 10 | Month | 11 | Day |
Date trial data considered complete
| 2024 | Year | 10 | Month | 11 | Day |
Date analysis concluded
| 2024 | Year | 10 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 19 | Day |
Last modified on
| 2024 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038895
