Efficacy of Pulmonary Vein Isolation Alone in Patients With Persistent Atrial Fibrillation (EARNEST-PVI)
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|ClinicalTrials.gov Identifier: NCT03514693|
Recruitment Status : Unknown
Verified April 2018 by Osaka Cardiovascular Conference.
Recruitment status was: Active, not recruiting
First Posted : May 2, 2018
Last Update Posted : May 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Catheter Ablation Recurrence||Procedure: PVI Procedure: PVI plus additional ablation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||512 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Randomized Controlled, Non-inferiority Trial Investigating Efficacy and Safety of Pulmonary Vein Isolation Alone for Recurrence Prevention Compared to Extensive Ablation in Patients With Persistent Atrial Fibrillation|
|Actual Study Start Date :||March 2, 2016|
|Estimated Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||March 31, 2019|
Active Comparator: PVI alone
PVI, and ablation for AF triggers from non-PV foci, the cavotricuspid isthmus, clinical coexisting tachyarrhythmia such as atrial flutter (AFL), atrial tachycardia (AT), and supraventricular tachycardia, if necessary
Ipsilateral circumferential PVI is the recommended PVI strategy. The success of PVI is defined as the achievement of the dissociation of PV potentials in all PVs. Disappearance of PV potentials is reconfirmed at the end of the procedure, a minimum of 20 minutes after the initial success of PVI.
Placebo Comparator: PVI plus additional ablation
PVI, additional CFAE or linear ablation after PVI, and ablation for AF triggers from non-PV foci, the cavotricuspid isthmus, clinical coexisting tachyarrhythmia such as atrial flutter (AFL), atrial tachycardia (AT), and supraventricular tachycardia, if necessary
Procedure: PVI plus additional ablation
In addition to PVI, CFAE ablation, linear ablation, or both; the choice of which is decided by the physician
- recurrence of AF documented by scheduled or symptom-driven ECG during 1 year after the procedure [ Time Frame: 1 year ]"Recurrence of AF" is defined as the documentation of any atrial arrhythmia including AF, AFL, and/or AT lasting ≥ 30 seconds by ECG or other appropriate tests.
- cardiovascular events [ Time Frame: 1 year ]death (and/or cause of death), or symptomatic cerebral infarction
- The effect of the presence or absence of AF trigger foci [ Time Frame: 1 year ]recurrence of AF according to the presence or absence of AF trigger foci
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514693
|Principal Investigator:||Yasushi Sakata, MD, PhD||Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine|