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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035940
Receipt No. 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 2019/08/22

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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
Email 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
Email hikoso@cardiology.med.osaka-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine
Institute
Department

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
Email 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)

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
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 Open public recruiting
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 19 Day
Last modified on
2019 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038895

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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