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NCT03514693: EARNEST-PVI

Efficacy of Pulmonary Vein Isolation Alone in Patients With Persistent Atrial Fibrillation

Status unknown NA Last updated 2 May 2018
What this trial tests

NA trial testing PVI in Atrial Fibrillation in 512 participants. Status unknown.

Timeline
2 March 2016
Primary endpoint
31 March 2019
31 March 2019

Quick facts

Lead sponsorOsaka Cardiovascular Conference
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment512
Start date2 March 2016
Primary completion31 March 2019
Estimated completion31 March 2019

Drugs / interventions tested

Conditions studied

Sponsor

Osaka Cardiovascular Conference

Who can join

Adults 20 to 80, any sex, with Atrial Fibrillation or Catheter Ablation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study examines non-inferiority of pulmonary vein isolation (PVI) for persistent atrial fibrillation (AF) to extensive ablation; and reveals the effect of the presence or origin of AF trigger on outcomes of catheter ablation.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Pulmonary vein isolation alone vs. more extensive ablation with defragmentation and linear ablation of persistent atrial fibrillation: the EARNEST-PVI trial.
    Inoue K, Hikoso S, Masuda M, Furukawa Y, et al · · 2021 · cited 68× · PMID 33200213 · DOI 10.1093/europace/euaa293
  2. DR-FLASH Score Is Useful for Identifying Patients With Persistent Atrial Fibrillation Who Require Extensive Catheter Ablation Procedures.
    Sato T, Sotomi Y, Hikoso S, Nakatani D, et al · · 2022 · cited 17× · PMID 35929474 · DOI 10.1161/jaha.121.024916
  3. Uplift modeling to identify patients who require extensive catheter ablation procedures among patients with persistent atrial fibrillation.
    Sato T, Sotomi Y, Hikoso S, Kitamura T, et al · · 2024 · cited 5× · PMID 38302547 · DOI 10.1038/s41598-024-52976-7
  4. Extensive ablation for elderly patients with persistent atrial fibrillation: insights from the EARNEST-PVI prospective randomized trial.
    Matsuoka Y, Sotomi Y, Hikoso S, Sunaga A, et al · · 2025 · cited 4× · PMID 39251131 · DOI 10.1016/j.jjcc.2024.09.001
  5. Impact of Initial Extensive Ablation on Left Atrial Gaps During Redo Procedures and Subsequent Outcomes in Persistent Atrial Fibrillation.
    Okada M, Inoue K, Tanaka N, Masuda M, et al · · 2025 · cited 1× · PMID 40455466 · DOI 10.1161/circep.124.013612
  6. Association between oral anticoagulants continuation on thromboembolism and bleeding events in patients with CHADS<sub>2</sub> score 0-2 points after catheter ablation for persistent atrial fibrillation.
    Nakano T, Oka T, Okayama K, Tanaka N, et al · · 2025 · cited 1× · PMID 40287088 · DOI 10.1016/j.jjcc.2025.04.004
  7. Left atrial functional deterioration after beyond-pulmonary vein isolation strategy predominantly consisting of linear ablation: Insights from the EARNEST-PVI Trial.
    Oka T, Koyama Y, Tanaka N, Sekihara T, et al · · 2026 · PMID 41839239 · DOI 10.1016/j.ijcard.2026.134429

Verify or expand the search:

Other trials of PVI

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Currently open trials in the same condition.

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Data sources for this page

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