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

Atrial Fibrillation Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03514693
• Other study ID #: 14377-8
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2, 2016
• Est. completion date: March 31, 2019

Study information

• Verified date: April 2018
• Source: Osaka Cardiovascular Conference
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 512
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Catheter Ablation
• Recurrence

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Osaka Cardiovascular Conference

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	cardiovascular events	death (and/or cause of death), or symptomatic cerebral infarction	1 year
Secondary	The effect of the presence or absence of AF trigger foci	recurrence of AF according to the presence or absence of AF trigger foci	1 year

External Links

•   UMIN-CTR