UMIN-CTR Clinical Trial

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