Atrial Fibrillation Clinical Trial
— EARNEST-PVIOfficial 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
Verified date | April 2018 |
Source | Osaka Cardiovascular Conference |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Osaka Cardiovascular Conference |
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 |
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