UMIN-CTR Clinical Trial

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

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

Objectives
Narrative objectives1	To evaluate histology of the atrium in patients with atrial fibrillation
Basic objectives2	Others
Basic objectives -Others	histological evaluation
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Relationship between atrial histology and recurrence rate at 3 years after catheter ablation for atrial fibrillation
Key secondary outcomes	Relationship between histological findings and electrophysiological data Relationship between atrial histology and cardiovascular event rate at 3 years after catheter ablation for atrial fibrillation

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	Patients undergoing catheter ablation for atrial fibrillation and/or left atrial macroreentrant atrial tachycardia Patients undergoing trans-esophageal echocardiography before ablation procedure Patient undergoing atrial fibrillation ablation under general anesthesia or deep sedation Patients undergoing bipolar voltage mapping in the atria during ablation procedure
Key exclusion criteria	Pregnant woman Patients in whom thrombus was identified in the left atrium Patients in whom trans-esophageal echocardiography would be impossible Patients with a history of open-heart surgery
Target sample size	100

Research contact person
Name of lead principal investigator	1st name TAKANORI Middle name Last name YAMAGUCHI
Organization	Saga University Hospital
Division name	Cardiovascular Medicine
Zip code	849-8501
Address	5-1-1 Nabeshima,Saga
TEL	0952-34-2443
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	Cardiovascular Medicine
Zip code	849-8501
Address	5-1-1 Nabeshima,Saga
TEL	0952-34-2443
Homepage URL
Email	takanori@cc.saga-u.ac.jp

Sponsor
Institute	Saga University Hospital
Institute
Department

Funding Source
Organization	Saga University Hospital
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	5-1-1 Nabeshima,Saga
Tel	0952-34-3400
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） 東京大学医学部付属病院循環器内科（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）

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 16 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	100
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 02 Month 20 Day
Date of IRB	2020 Year 04 Month 06 Day
Anticipated trial start date	2020 Year 06 Month 04 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

Cohort study April 6,2020-December 31,2022 Patients undergoing catheter ablation for atrial fibrillation and/or left atrial macroreentrant atrial tachycardia Patients undergoing trans-esophageal echocardiography before ablation procedure Patient undergoing atrial fibrillation ablation under general anesthesia or deep sedation Patients undergoing bipolar voltage mapping in the atria during ablation procedure

Management information
Registered date	2020 Year 06 Month 16 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=R000046506