Unique ID issued by UMIN | UMIN000035284 |
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Receipt number | R000040194 |
Scientific Title | Nagano Chuo Hospital Balloon Ablation Study |
Date of disclosure of the study information | 2018/12/27 |
Last modified on | 2023/12/08 12:07:50 |
Nagano Chuo Hospital Balloon Ablation Study
Hot and Ice Study
Nagano Chuo Hospital Balloon Ablation Study
Hot and Ice Study
Japan |
Atrial fibrillation
Cardiology |
Others
NO
To compare the efficacy of HotBalloon ablation and that of CryoBalloon ablation in patients with paroxysmal atrial fibrillation who undergoing pulmonary vein isolation.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Recurrence of any atrial fibrillation or atrial tachycardia by 12 months from ablation
1.touch-up rate by radio-frequency ablation
2.procedure time (From puncture start to sheath removal)
3.fluoroscopy time
4.complications rate by treatment (Period: 3 months)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
YES
2
Treatment
Maneuver |
HotBalloon ablation
Sheath:TRESWALTZ
Balloon:SATAKE HotBalloonCatheter(Injection volume:8~20ml)
CryoBalloon ablation
Sheath:FlexCath Advance Steerable Sheath
Balloon:Arctic Front Advance Cryo Balloon Catheter(Catheter size:28mm)
20 | years-old | <= |
Not applicable |
Male and Female
Patients with paroxysmal atrial fibrillation qualified to catheter ablation according to current standards
1. unsuitable anatomy of pulmonary vein or left atrium for balloon ablation
2. life expectancy < 12 months
3. difficult to follow up 12 months
200
1st name | Kono |
Middle name | |
Last name | Tsunesuke |
Nagano Chuo Hospital
Cardiology
380-0814
1570 Nishitsurugamachi,Nagano,380-0814,Japan
026-234-3211
hdc@healthcoop-nagano.or.jp
1st name | Daisuke |
Middle name | |
Last name | Yamagishi |
Nagano Chuo Hospital
Department of Heart Disease Center
380-0814
1570 Nishitsurugamachi,Nagano,380-0814,Japan
026-234-3211
hdc@healthcoop-nagano.or.jp
Nagano Chuo Hospital
Nagano Chuo Hospital
Other
Nagano Chuo Hospital IRB
1570 Nishitsurugamachi,Nagano,380-0814Japan
026-234-3211
mayumi.nakazawa@healthcoop-nagano.or.jp
NO
2018 | Year | 12 | Month | 27 | Day |
Unpublished
200
Delay expected |
Due to the time required to write the article, including statistical analysis, the publication of the results has been delayed.
We are currently on the verge of submitting the article and plan to do so soon.
No longer recruiting
2018 | Year | 11 | Month | 12 | Day |
2018 | Year | 11 | Month | 21 | Day |
2019 | Year | 01 | Month | 09 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 11 | Month | 01 | Day |
2022 | Year | 12 | Month | 28 | Day |
2023 | Year | 01 | Month | 31 | Day |
2018 | Year | 12 | Month | 17 | Day |
2023 | Year | 12 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040194
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