UMIN-CTR Clinical Trial

Basic information
Public title	The Randomized Controlled Trial Evaluating Utility of Catheter Ablation Us ing New Strategy Targeting Arrhythmogenic Substrate in Atrial Fibrillation Patients (CONTROL-AF)
Acronym	CONTROL-AF
Scientific Title	COmparing New strategy Targeting aRrhythmogenic substrate Of Lasting-A trial Fibrillation (CONTROL-AF) Study
Scientific Title:Acronym	CONTROL-AF
Region	Japan

Condition
Condition	atrial fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluated the utility of new ablation strategy targeting arrhythmogenic substrate (CARTO FINDER, and ExTRa mapping) in reduce recurrent atrial tachyarrhythmias after procedure.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Atrial arrhythmia recurrence beyond 90 days after catheter ablation for atrial fibrillation
Key secondary outcomes	Atrial fibrillation termination rate Atrial fibrillation-free survival, atrial tachycardia-free survival Procedure detail (procedure time, ablation number, ablation region) Adverse events Atrial arrhythmia recurrence beyond 90 days after repeat procedures The difference of results compared between the different ExTRa-guide ablation in combined data with ROTATE study Study results compared with matched historical control

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Patients received CARTO FINDER-guided ablation or ExTRa mapping-guided ablation. In FINDER group, atrial sites of focal activation pattern were ablated, and electrical cardiversion was performed when sinus restoration was not obtained in 15 minutes after injection of Nifekalant 0.3mg/kg.
Interventions/Control_2	In ExTRa group, atrial sites of high %NP (%NP >35% for the first 20 pts., and %NP >35% and LVZ <0.5mV for the next 20 pts) were ablated, and electrical car diversion was performed when sinus restand electrical cardiversion was performed when sinus restoration was not obtained in 15 minutes after injection of Nifekalant 0.3mg/kg.
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	21 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	First time ablation procedure for persistent atrial fibrillation Patients who can be followed for at least 1-year after procedure Patients from who we get written informed consent
Key exclusion criteria	Patients whose atrial fibrillation was restored after only pulmonay veins isolation Patients who received ablation procedure or MAZE procedure for for atrial fibrillation before enrollment
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Shizuta
Organization	Kyoto University Hospital
Division name	Department of Cardiovascular Medicine
Zip code	606-8507
Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL	075-751-4254
Email	shizuta@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Tetsuma Middle name Last name Kawaji
Organization	Mitsubishi Kyoto Hospital
Division name	Department of Cardiology
Zip code	615-8087
Address	1 Katsura Gosho-cho, Nishikyo-ku, Kyoto
TEL	075-381-2111
Homepage URL
Email	kawaji@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Hospital
Institute
Department

Funding Source
Organization	Operation Cost Grant 021010
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kyoto University Graduate School of Medicine and Faculty of Medicine, Ethics Committee
Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Kyoto, Kyoto
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-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	三菱京都病院（京都）、京都大学医学部附属病院(京都)

Other administrative information
Date of disclosure of the study information	2021 Year 06 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	2021 Year 06 Month 01 Day
Date of IRB	2021 Year 04 Month 13 Day
Anticipated trial start date	2021 Year 06 Month 01 Day
Last follow-up date	2027 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 02 Month 19 Day
Last modified on	2022 Year 02 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049543