Efficacy of Pulmonary Vein Isolation Alone in Patients With Persistent Atrial Fibrillation (EARNEST-PVI)
Primary Purpose
Atrial Fibrillation, Catheter Ablation, Recurrence
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PVI
PVI plus additional ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Persistent atrial fibrillation, non-inferiority trial
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
PVI alone
PVI plus additional ablation
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
cardiovascular events
death (and/or cause of death), or symptomatic cerebral infarction
The effect of the presence or absence of AF trigger foci
recurrence of AF according to the presence or absence of AF trigger foci
Full Information
NCT ID
NCT03514693
First Posted
April 20, 2018
Last Updated
April 20, 2018
Sponsor
Osaka Cardiovascular Conference
1. Study Identification
Unique Protocol Identification Number
NCT03514693
Brief Title
Efficacy of Pulmonary Vein Isolation Alone in Patients With Persistent Atrial Fibrillation
Acronym
EARNEST-PVI
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2016 (Actual)
Primary Completion Date
March 31, 2019 (Anticipated)
Study Completion Date
March 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Osaka Cardiovascular Conference
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Catheter Ablation, Recurrence
Keywords
Persistent atrial fibrillation, non-inferiority trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
512 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PVI alone
Arm Type
Active Comparator
Arm Description
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
Arm Title
PVI plus additional ablation
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
PVI
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
PVI plus additional ablation
Intervention Description
In addition to PVI, CFAE ablation, linear ablation, or both; the choice of which is decided by the physician
Primary Outcome Measure Information:
Title
recurrence of AF documented by scheduled or symptom-driven ECG during 1 year after the procedure
Description
"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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
cardiovascular events
Description
death (and/or cause of death), or symptomatic cerebral infarction
Time Frame
1 year
Title
The effect of the presence or absence of AF trigger foci
Description
recurrence of AF according to the presence or absence of AF trigger foci
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasushi Sakata, MD, PhD
Organizational Affiliation
Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35929474
Citation
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.
Results Reference
derived
PubMed Identifier
35912709
Citation
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.
Results Reference
derived
PubMed Identifier
33200213
Citation
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.
Results Reference
derived
Links:
URL
https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022454
Description
UMIN-CTR
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Efficacy of Pulmonary Vein Isolation Alone in Patients With Persistent Atrial Fibrillation
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