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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046658
Receipt No. R000051750
Scientific Title Follow-Up study of paTients UndeRgoing cathEter ablation for Atrial Fibrillation: evaluation of long-term outcomes and predictive factors based on genetic predisposition
Date of disclosure of the study information 2022/01/17
Last modified on 2022/01/17

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Basic information
Public title Follow-Up study of paTients UndeRgoing cathEter ablation for Atrial Fibrillation: evaluation of long-term outcomes and predictive factors based on genetic predisposition

Acronym FUTURE-AF Study
Scientific Title Follow-Up study of paTients UndeRgoing cathEter ablation for Atrial Fibrillation: evaluation of long-term outcomes and predictive factors based on genetic predisposition

Scientific Title:Acronym FUTURE-AF Study
Region
Japan

Condition
Condition atrial fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate whether genetic markers or genetic risk scores for atrial fibrillation predict the incidence of cardiovascular events and recurrence of atrial fibrillation at 36 months after atrial fibrillation ablation in a Japanese population
Basic objectives2 Others
Basic objectives -Others Cross-sectional evaluation of the association of single-nucleotide polymorphisms with clinical background and electrophysiological factors.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Association between genetic markers or genetic risk scores and cardiovascular events at 36 months post catheter ablation
Key secondary outcomes Association between genetic markers or genetic risk scores and atrial fibrillation recurrence at 36 months post catheter ablation

Association between genetic markers or genetic risk scores and implantation of cardiac devices at 36 months post catheter ablation

Association between genetic markers or genetic risk scores and clinical backgrounds

Association between genetic markers or genetic risk scores and echocardiographic data

Association between genetic markers or genetic risk scores and electrocardiographic findings

Association between genetic markers or genetic risk scores and electrophysiological findings

Association of genetic markers, genetic risk scores with clinical scores such as CHADS2 score, CHA2DS2-Vasc score, HASBLED score and comparison of the performance between the scores

Genome-wide association analysis using study participants as atrial fibrillation cases

Association of blood biomarkers with genetic markers and genetic risk scores

Association between blood biomarkers and atrial tachyarrhythmia recurrence rate at 36 months post catheter ablation

Association between blood biomarkers and cardiovascular events at 36 months post catheter ablation

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 (1) Patients who undergo radiofrequency catheter ablation for atrial fibrillation during the period from the approval of the ethical review of clinical research to December 31, 2026.
(2) Age 20 years or older
Key exclusion criteria Patients who are judged by the attending physician to be unsuitable for participation in the study
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name TAKANORI
Middle name
Last name YAMAGUCHI
Organization Saga University Hospital
Division name Department of Cardiovascular Medicine
Zip code 849-8501
Address 5-1-1Nabeshima,Saga
TEL 0952342443
Email takanori@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name TAKANORI
Middle name
Last name YAMAGUCHI
Organization Saga University Hospital
Division name Department of Cardiovascular Medicine
Zip code 849-8501
Address 5-1-1Nabeshima,Saga
TEL 0952342443
Homepage URL
Email takanori@cc.saga-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Saga University
Institute
Department

Funding Source
Organization Department of Cardiovascular Medicine, Saga University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization CLINICAL RESEARCH CENTER,SAGA UNIVERSITY HOSPITAL
Address 5-1-1Nabeshima,Saga
Tel 0952343400
Email kenkyu-shinsei@ml.cc.saga-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 大分大学医学部循環器内科・臨床検査診断学講座(大分)
佐賀県医療センター好生館循環器内科(佐賀)
嬉野医療センター循環器内科(佐賀)
済生会二日市病院循環器内科(福岡)
東京大学医学部附属病院循環器内科(東京)
理化学研究所生命医科学研究センター(神奈川)
国立長寿医療研究センターメディカルゲノムセンター(愛知)
京都大学医学部附属病院循環器内科(京都)
県立広島病院循環器内科(広島)
三菱京都病院心臓内科(京都)
医療法人札幌ハートセンター札幌心臓血管クリニック循環器内科(北海道)

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 17 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
2021 Year 06 Month 29 Day
Date of IRB
2021 Year 08 Month 20 Day
Anticipated trial start date
2021 Year 09 Month 01 Day
Last follow-up date
2026 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The incidence of cardiovascular events and recurrence of atrial fibrillation will be evaluated at 36 months post catheter ablation

Management information
Registered date
2022 Year 01 Month 17 Day
Last modified on
2022 Year 01 Month 17 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051750

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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