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Efficacy of Pulmonary Vein Isolation Alone in Patients With Persistent Atrial Fibrillation (EARNEST-PVI)

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ClinicalTrials.gov Identifier: NCT03514693
Recruitment Status : Active, not recruiting
First Posted : May 2, 2018
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Osaka Cardiovascular Conference

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Catheter Ablation Recurrence Procedure: PVI Procedure: PVI plus additional ablation Not Applicable

Detailed Description:
Study design The EARNEST-PVI trial is a prospective, multicenter, randomized, open-label non-inferiority trial in which patients with persistent AF will undergo ablation. After providing written informed consent at each hospital, patients who are eligible for the trial will be randomized to either PVI alone or PVI plus additional ablation. Left atrial dimensions will be the only adjustment factor considered in dynamic allocation to avoid bias. Patients randomized to the PVI alone group will be treated with PVI, while patients randomized to the PVI plus additional ablation group will receive additional complex fractionated atrial electrogram or linear ablation after PVI. 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 will be allowed in both groups. Patients will be followed up 1, 3, 6, 9, and 12 months after the procedure. The primary endpoint of the study is the 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. The sample size and randomization are specified based on the concept of non-inferiority to achieve the primary objective. The recurrence rate of AF was assumed to be 40% in both groups and a non-inferiority margin of 10% was calculated by referring to the previous studies. Therefore, a sample size of 256 subjects in each group is required with a power of 80% and significance level of 5% considering some dropouts. The statistical evaluation will be carried out according to the intention-to-treat principle.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 512 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Procedure: PVI
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. cardiovascular events [ Time Frame: 1 year ]
    death (and/or cause of death), or symptomatic cerebral infarction

  2. 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



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Osaka Cardiovascular Conference
Investigators
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Principal Investigator: Yasushi Sakata, MD, PhD Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine

Additional Information:
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Responsible Party: Osaka Cardiovascular Conference
ClinicalTrials.gov Identifier: NCT03514693     History of Changes
Other Study ID Numbers: 14377-8
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Osaka Cardiovascular Conference:
Persistent atrial fibrillation
non-inferiority trial
Additional relevant MeSH terms:
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Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes