Unique ID issued by UMIN | UMIN000043392 |
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Receipt number | R000049543 |
Scientific Title | COmparing New strategy Targeting aRrhythmogenic substrate Of Lasting-A trial Fibrillation (CONTROL-AF) Study |
Date of disclosure of the study information | 2021/06/01 |
Last modified on | 2022/02/18 19:52:46 |
The Randomized Controlled Trial Evaluating Utility of Catheter Ablation Us ing New Strategy Targeting Arrhythmogenic Substrate in Atrial Fibrillation Patients
(CONTROL-AF)
CONTROL-AF
COmparing New strategy Targeting aRrhythmogenic substrate Of Lasting-A trial Fibrillation (CONTROL-AF) Study
CONTROL-AF
Japan |
atrial fibrillation
Cardiology |
Others
NO
To evaluated the utility of new ablation strategy targeting arrhythmogenic substrate (CARTO FINDER, and ExTRa mapping) in reduce recurrent atrial tachyarrhythmias after procedure.
Efficacy
Atrial arrhythmia recurrence beyond 90 days after catheter ablation for atrial fibrillation
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
YES
2
Treatment
Device,equipment |
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.
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.
21 | years-old | <= |
90 | years-old | >= |
Male and Female
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
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
80
1st name | Satoshi |
Middle name | |
Last name | Shizuta |
Kyoto University Hospital
Department of Cardiovascular Medicine
606-8507
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
075-751-4254
shizuta@kuhp.kyoto-u.ac.jp
1st name | Tetsuma |
Middle name | |
Last name | Kawaji |
Mitsubishi Kyoto Hospital
Department of Cardiology
615-8087
1 Katsura Gosho-cho, Nishikyo-ku, Kyoto
075-381-2111
kawaji@kuhp.kyoto-u.ac.jp
Kyoto University Hospital
Operation Cost Grant 021010
Other
Mitsubisi Kyoto Hospital
Kyoto University Graduate School of Medicine and Faculty of Medicine, Ethics Committee
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Kyoto, Kyoto
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
NO
三菱京都病院(京都)、京都大学医学部附属病院(京都)
2021 | Year | 06 | Month | 01 | Day |
Unpublished
Open public recruiting
2021 | Year | 06 | Month | 01 | Day |
2021 | Year | 04 | Month | 13 | Day |
2021 | Year | 06 | Month | 01 | Day |
2027 | Year | 04 | Month | 01 | Day |
2021 | Year | 02 | Month | 19 | Day |
2022 | Year | 02 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049543
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