Unique ID issued by UMIN | UMIN000019449 |
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Receipt number | R000022454 |
Scientific Title | Effect of Extensive Ablation on Recurrence in Patients with Persistent Atrial Fibrillation Treated with Pulmonary Vein Isolation -a Multicenter, Randomized, Open-Label, Non-Inferiority Study- |
Date of disclosure of the study information | 2015/10/22 |
Last modified on | 2023/10/15 18:08:58 |
Effect of Extensive Ablation on Recurrence in Patients with Persistent Atrial Fibrillation Treated with Pulmonary Vein Isolation -a Multicenter, Randomized, Open-Label, Non-Inferiority Study-
Effect of Extensive Ablation on Recurrence in Patients with Persistent Atrial Fibrillation Treated with Pulmonary Vein Isolation (EARNEST-PVI)
Effect of Extensive Ablation on Recurrence in Patients with Persistent Atrial Fibrillation Treated with Pulmonary Vein Isolation -a Multicenter, Randomized, Open-Label, Non-Inferiority Study-
Effect of Extensive Ablation on Recurrence in Patients with Persistent Atrial Fibrillation Treated with Pulmonary Vein Isolation (EARNEST-PVI)
Japan |
Persistent atrial fibrillation
Cardiology |
Others
NO
To examine non-inferiority of pulmonary vein isolation for persistent atrial fibrillation (AF) to extensive ablation; and to reveal the effect of the presence or the origin of AF trigger on outcomes of catheter ablation
Bio-equivalence
Confirmatory
Pragmatic
Not applicable
the one-year recurrence rate of atrial fibrillation following the first session of catheter ablation
cardiovascular events:
death (and/or cause of death), symptomatic cerebral infarction, the recurrence rate of atrial fibrillation following multiple ablations; complications associated with catheter ablation; Total energy; procedure time; and QOL score assessed by SF-36
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Maneuver |
Group A: Pulmonary vein isolation
Group B: Pulmonary vein isolation with extensive ablations
20 | years-old | <= |
80 | years-old | > |
Male and Female
Patients undergoing a first-time ablation procedure for persistent atrial fibrillation
Patients with sustained atrial fibrillation episode 5 years or greater;
Patients with left atrial size 50 mm or larger or left atrial volume 200ml or larger;
Patients with valvular atrial fibrillation and a history of cardiac surgery;
Patients age is < 20 years or 80 years or greater;
Dialysis patients;
Patients with heart failure (LVEF < 30% or NYHA class III or IV);
Patients taking antiarrhythmic drugs before procedure; or
Patients considered unsuitable for this study
512
1st name | Yasushi |
Middle name | |
Last name | Sakata |
Osaka University Graduate School of Medicine
Department of Cardiovascular Medicine
565-0871
2-2 Yamadaoka, Suita, Osaka, Japan
06-6879-3631
yasushisk@cardiology.med.osaka-u.ac.jp
1st name | Shungo |
Middle name | |
Last name | Hikoso |
Osaka University Graduate School of Medicine
Department of Cardiovascular Medicine
565-0871
2-2 Yamadaoka, Suita, Osaka, Japan
06-6879-3631
hikoso@cardiology.med.osaka-u.ac.jp
Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine
Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine
Self funding
Osaka university hospital
2-15 Yamadaoka, Suita, Osaka, Japan
06-6210-8289
rinri@hp-crc.med.osaka-u.ac.jp
NO
大阪大学医学部附属病院 循環器内科(大阪府)、大阪警察病院(大阪府)、大阪府立急性期・総合医療センター(大阪府)、大阪労災病院(大阪府)、関西労災病院(兵庫県)、特定医療法人渡辺医学会桜橋渡辺病院(大阪府)、八尾市立病院(大阪府)、JCHO大阪病院(大阪府)
2015 | Year | 10 | Month | 22 | Day |
Unpublished
Completed
2015 | Year | 10 | Month | 16 | Day |
2015 | Year | 10 | Month | 14 | Day |
2016 | Year | 03 | Month | 02 | Day |
2019 | Year | 03 | Month | 31 | Day |
2015 | Year | 10 | Month | 22 | Day |
2023 | Year | 10 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022454
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