UMIN-CTR Clinical Trial

Basic information
Public title	Histological Evaluation of Atrial Fibrillation Substrate Based on Atrial Septum Biopsy 2
Acronym	HEAL-AF Study 2
Scientific Title	Histological Evaluation of Atrial Fibrillation Substrate Based on Atrial Septum Biopsy 2
Scientific Title:Acronym	HEAL-AF Study 2
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the relationship between histological findings based on atrial biopsy and outcomes at 3 years post-atrial fibrillation ablation
Basic objectives2	Others
Basic objectives -Others	Histological evaluation of biopsy samples from the right atrium in patients with atrial fibrillation
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Relationship between histological findings based on atrial biopsy and outcomes at 3 years post-atrial fibrillation ablation
Key secondary outcomes	Histological evaluation of biopsy samples from the right atrium in patients with atrial fibrillation Relationship between histological and electrophysiological findings Relationship between histological findings and clinical factors Relationship between histological findings and gene expression

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 undergoing catheter ablation for atrial fibrillation between January 2021 and December 2022 2) Patients over 20 years old
Key exclusion criteria	1) Patients who are pregnant or who may become pregnant 2) Patients with thrombus in the left atrium 3) Other patients who are judged by the attending physician to be unable to participate in the study
Target sample size	300

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） 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（愛知）

Other administrative information
Date of disclosure of the study information	2021 Year 07 Month 26 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	No longer recruiting
Date of protocol fixation	2020 Year 10 Month 30 Day
Date of IRB	2020 Year 12 Month 07 Day
Anticipated trial start date	2021 Year 01 Month 08 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Recurrence of atrial tachyarrhythmias and cardiovascular events will be evaluated at 3, 6, 12, 24, and 36 months after ablation. Echocardiography and blood tests will also be performed at 12 and 36 months post-ablation.

Management information
Registered date	2021 Year 07 Month 23 Day
Last modified on	2022 Year 07 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050441