NCT03514693

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
512

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable atrial-fibrillation

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 2, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2018

Enrollment Period

3.1 years

First QC Date

April 20, 2018

Last Update Submit

April 20, 2018

Conditions

Atrial FibrillationCatheter AblationRecurrence

Keywords

Persistent atrial fibrillationnon-inferiority trial

Outcome Measures

Primary Outcomes (1)

  • recurrence of AF documented by scheduled or symptom-driven ECG during 1 year after the procedure

    "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.

    1 year

Secondary Outcomes (2)

  • cardiovascular events

    1 year

  • The effect of the presence or absence of AF trigger foci

    1 year

Study Arms (2)

PVI alone

ACTIVE COMPARATOR

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

PVI plus additional ablation

PLACEBO COMPARATOR

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

Interventions

PVIPROCEDURE

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.

PVI alone
PVI plus additional ablationPROCEDURE

In addition to PVI, CFAE ablation, linear ablation, or both; the choice of which is decided by the physician

PVI plus additional ablation

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing a first-time ablation procedure for persistent AF

You may not qualify if:

  • Patients with long-standing persistent AF lasting ≥ 5 years
  • Patients with left atrial dimension ≥ 50 mm by 2-dimensional echocardiography
  • Patients with valvular AF (defined as the presence of mitral or aortic stenosis or regurgitation with a history of rheumatic fever or implantation of artificial heart valves)
  • Patients who underwent prior cardiac surgery
  • Patients receiving hemodialysis
  • Patients with heart failure (left ventricular ejection fraction \< 30% and NYHA class ≥ III)
  • Patients receiving antiarrhythmic agents before the ablation procedure (within 60 days for amiodarone, or 5 half-lives for other drugs)
  • Patients who are not considered to be suitable candidates by the attending physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Okada M, Inoue K, Tanaka N, Masuda M, Watanabe T, Makino N, Egami Y, Oka T, Minamiguchi H, Miyoshi M, Kanda T, Matsuda Y, Kawasaki M, Tanaka K, Hirao Y, Hikoso S, Sunaga A, Dohi T, Nakatani D, Okada K, Sotomi Y, Sakata Y; Osaka Cardiovascular Conference (OCVC)-Arrhythmia Investigators*. Impact of Initial Extensive Ablation on Left Atrial Gaps During Redo Procedures and Subsequent Outcomes in Persistent Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2025 Jun;18(6):e013612. doi: 10.1161/CIRCEP.124.013612. Epub 2025 Jun 2.

    PMID: 40455466DERIVED

  • Matsuoka Y, Sotomi Y, Hikoso S, Sunaga A, Nakatani D, Okada K, Dohi T, Sato T, Kida H, Sakamoto D, Kitamura T, Tanaka N, Masuda M, Watanabe T, Minamiguchi H, Egami Y, Oka T, Miyoshi M, Okada M, Matsuda Y, Kawasaki M, Inoue K, Sakata Y; OCVC-Arrhythmia Investigators. Extensive ablation for elderly patients with persistent atrial fibrillation: insights from the EARNEST-PVI prospective randomized trial. J Cardiol. 2025 Apr;85(4):301-308. doi: 10.1016/j.jjcc.2024.09.001. Epub 2024 Sep 7.

    PMID: 39251131DERIVED

  • Matsunaga-Lee Y, Inoue K, Tanaka N, Masuda M, Watanabe T, Makino N, Egami Y, Oka T, Minamiguchi H, Miyoshi M, Okada M, Kanda T, Matsuda Y, Kawasaki M, Kawanami S, Sugae H, Ukita K, Kawamura A, Yasumoto K, Tsuda M, Okamoto N, Yano M, Nishino M, Sunaga A, Sotomi Y, Dohi T, Nakatani D, Hikoso S, Sakata Y; Osaka Cardiovascular Conference (OCVC) Arrhythmia Investigators. Appropriate Selection of Substrate Ablation for Persistent Atrial Fibrillation Using Intraprocedural Assessment. Circ J. 2024 Jun 25;88(7):1068-1077. doi: 10.1253/circj.CJ-23-0936. Epub 2024 May 30.

    PMID: 38811199DERIVED

  • Sato T, Sotomi Y, Hikoso S, Nakatani D, Mizuno H, Okada K, Dohi T, Kitamura T, Sunaga A, Kida H, Oeun B, Egami Y, Watanabe T, Minamiguchi H, Miyoshi M, Tanaka N, Oka T, Okada M, Kanda T, Matsuda Y, Kawasaki M, Masuda M, Inoue K, Sakata Y; Osaka Cardio Vascular Conference (OCVC)-Arrhythmia Investigators *. DR-FLASH Score Is Useful for Identifying Patients With Persistent Atrial Fibrillation Who Require Extensive Catheter Ablation Procedures. J Am Heart Assoc. 2022 Aug 16;11(16):e024916. doi: 10.1161/JAHA.121.024916. Epub 2022 Aug 5.

    PMID: 35929474DERIVED

  • Curran L, Nah G, Marcus GM, Tseng Z, Crawford MH, Parikh NI. Clinical Correlates and Outcomes of Methamphetamine-Associated Cardiovascular Diseases in Hospitalized Patients in California. J Am Heart Assoc. 2022 Aug 16;11(16):e023663. doi: 10.1161/JAHA.121.023663. Epub 2022 Aug 1.

    PMID: 35912709DERIVED

  • Inoue K, Hikoso S, Masuda M, Furukawa Y, Hirata A, Egami Y, Watanabe T, Minamiguchi H, Miyoshi M, Tanaka N, Oka T, Okada M, Kanda T, Matsuda Y, Kawasaki M, Hayashi K, Kitamura T, Dohi T, Sunaga A, Mizuno H, Nakatani D, Sakata Y; OCVC Arrhythmia Investigators. Pulmonary vein isolation alone vs. more extensive ablation with defragmentation and linear ablation of persistent atrial fibrillation: the EARNEST-PVI trial. Europace. 2021 Apr 6;23(4):565-574. doi: 10.1093/europace/euaa293.

    PMID: 33200213DERIVED

Related Links

MeSH Terms

Conditions

Atrial FibrillationRecurrence

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Yasushi Sakata, MD, PhD

    Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2018

First Posted

May 2, 2018

Study Start

March 2, 2016

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

May 2, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share