Atrial FibrillationEARNEST-PVINCT03514693
Efficacy of Pulmonary Vein Isolation Alone in Patients With Persistent Atrial Fibrillation
A study testing PVI and PVI plus additional ablation in people with Atrial Fibrillation and Catheter Ablation, run by Osaka Cardiovascular Conference.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Catheter Ablation, Recurrence
- What is being tested?
- PVI and PVI plus additional ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 512 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2016to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing a first-time ablation procedure for persistent AF
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Catheter Ablation, Recurrence
- Being tested
- PVI, PVI plus additional ablation
- Keywords
- Persistent atrial fibrillation, non-inferiority trial
- Medical subject headings
- Atrial Fibrillation, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVIProcedure or surgery
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 plus additional ablationProcedure or surgery
In addition to PVI, CFAE ablation, linear ablation, or both; the choice of which is decided by the physician
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: PVI plus additional ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
cardiovascular events
death (and/or cause of death), or symptomatic cerebral infarction
Measured: 1 year
The effect of the presence or absence of AF trigger foci
recurrence of AF according to the presence or absence of AF trigger foci
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start2 Mar 2016
- Primary completion31 Mar 2019 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osaka Cardiovascular Conference
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yasushi Sakata, MD, PhD, Principal investigator, Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514693
- Sponsor's protocol ID
- 14377-8
- Acronym
- EARNEST-PVI
- Status last verified
- Apr 2018
- First submitted
- 20 Apr 2018
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40455466Matsuoka 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.
PubMed 39251131Matsunaga-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.
PubMed 38811199Sato 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.
PubMed 35929474Curran 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.
PubMed 35912709Inoue 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.
PubMed 33200213
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03514693
- Acronym / sponsor ID
- EARNEST-PVI / 14377-8
- Conditions
- Atrial Fibrillation, Catheter Ablation, Recurrence
- Keywords
- Persistent atrial fibrillation, non-inferiority trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Osaka Cardiovascular ConferenceUniversity, hospital or other
- Study start
- 2 Mar 2016 (actual)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI alone | Active comparator | Procedure: PVIPVI, 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 plus additional ablation | Placebo comparator | Procedure: PVI plus additional ablationPVI, 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing a first-time ablation procedure for persistent AF
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVIIpsilateral 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. | Procedure or surgery | PVI alone |
| PVI plus additional ablationIn addition to PVI, CFAE ablation, linear ablation, or both; the choice of which is decided by the physician | Procedure or surgery | PVI plus additional ablation |
Primary outcome
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.
2 secondary outcomes
cardiovascular events
Time frame: 1 year
The effect of the presence or absence of AF trigger foci
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Derived from this study: PubMed 40455466Okada 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.
- Derived from this study: PubMed 39251131Matsuoka 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.
- Derived from this study: PubMed 38811199Matsunaga-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.
- Derived from this study: PubMed 35929474Sato 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.
- Derived from this study: PubMed 35912709Curran 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.
- Derived from this study: PubMed 33200213Inoue 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.
- UMIN-CTRLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasushi Sakata, MD, PhD principal investigator
Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing PVI and PVI plus additional ablation in people with Atrial Fibrillation and Catheter Ablation, run by Osaka Cardiovascular Conference.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence of AF documented by scheduled or symptom-driven ECG during 1 year after the procedure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03514693, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.