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 -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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019449

Enrollment

512

Registered

2015-10-22

Start date

2016-03-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent atrial fibrillation

Interventions

Group A: Pulmonary vein isolation Group B: Pulmonary vein isolation with extensive ablations

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing a first-time ablation procedure for persistent atrial fibrillation

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
the one-year recurrence rate of atrial fibrillation following the first session of catheter ablation	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactShungo Hikoso

Osaka University Graduate School of Medicine Department of Cardiovascular Medicine

hikoso@cardiology.med.osaka-u.ac.jp06-6879-3631

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026