Unique ID issued by UMIN | UMIN000018901 |
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Receipt number | R000021873 |
Scientific Title | The safety and efficacy of radiofrequency ablation and cryoablation in patients with atrial fibrillation (AF) under anticoagulant therapy with apixaban |
Date of disclosure of the study information | 2015/09/03 |
Last modified on | 2017/09/29 12:35:34 |
The safety and efficacy of radiofrequency ablation and cryoablation in patients with atrial fibrillation (AF) under anticoagulant therapy with apixaban
The safety and efficacy of radiofrequency ablation and cryoablation in patients with atrial fibrillation (AF) under anticoagulant therapy with apixaban(J-HIT Study)
The safety and efficacy of radiofrequency ablation and cryoablation in patients with atrial fibrillation (AF) under anticoagulant therapy with apixaban
The safety and efficacy of radiofrequency ablation and cryoablation in patients with atrial fibrillation (AF) under anticoagulant therapy with apixaban(J-HIT Study)
Japan |
atrial fibrillation
Cardiology |
Others
NO
Comparing radiofrequency ablation and cryoablation in patients with AF taking apixaban, and demonstrate the safety and efficacy of both therapies.
Safety,Efficacy
Composite of major bleedings and thromboembolism during perioperative period and within 4 weeks after the surgery.
Recurrence of AF during the follow-up period (because the presence or absence of recurrence may be associated with the development of embolic events), non-major bleeding, pericardial effusions not requiring drainage.
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Active
2
Treatment
Medicine | Maneuver |
Apixaban_radiofrequency ablation
Apixaban_cryoablation
20 | years-old | <= |
85 | years-old | >= |
Male and Female
1)Patients who are indicated for catheter ablation for drug-resistant non-valvular paroxysmal AF in the Japanese Heart Rhythm Society Guidelines
2)Patients who undergo the first catheter ablation while taking apixaban
3)Patients of age between 20 and 85 years
4)Patients for whom consent for participation in this study have been obtained in writing
Patients with a history of hypersensitivity to the components of apixaban.
Patients with clinically significant bleeding symptoms.
Patients with blood clotting defect and liver disease at clinically significant bleeding risk.
260
1st name | |
Middle name | |
Last name | Kenzo Hirao |
Tokyo Medical and Dental University
Heart Rhythm Center
1-5-45, Yushima, Bunkyo-ku, Tokyo
03-5803-5231
0160.cvm@tmd.ac.jp
1st name | |
Middle name | |
Last name | Atsuhiko Yagishita |
Tokyo Medical and Dental University
Department of Advanced technology in medicine
1-5-45, Yushima, Bunkyo-ku, Tokyo
03-5803-5231
atsuhikoyagishita.cvm@tmd.ac.jp
Tokyo Medical and Dental University
Bristol-Myers Squibb
Profit organization
NO
さいたま赤十字病院(埼玉県)、土浦協同病院(茨城県)、横須賀共済病院(神奈川県)、武蔵野赤十字病院(東京都)
2015 | Year | 09 | Month | 03 | Day |
Unpublished
No longer recruiting
2015 | Year | 06 | Month | 30 | Day |
2015 | Year | 09 | Month | 03 | Day |
2015 | Year | 09 | Month | 03 | Day |
2017 | Year | 09 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021873
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