Atrial Fibrillation Clinical Trial
— POWER-FASTOfficial title:
High-power Short-duration Radiofrequency Application for Faster and Safer Pulmonary Vein Ablation Trial (POWER FAST III Trial)
NCT number | NCT04153747 |
Other study ID # | 5064 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 25, 2019 |
Est. completion date | December 30, 2023 |
Verified date | January 2024 |
Source | Hospital Universitario La Paz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Multicenter 1:1 randomized study. Two atrial fibrillation ablation strategies are compared: 1) conventional ablation using point-by-point radiofrequency applications with power 40 W guided by LSI > 6 or AI > 500 on the anterior aspect of pulmonary veins and power 25 W guided by LSI >5 or AI >350 on the posterior wall near the esophagus; 2) point-by-point RF applications with power set at 70 W and duration 9-10 s. The main objective of the trial is the incidence of esophageal lesions evaluated with systematic endoscopy and clinical efficacy evaluated with daily ECG transtelephonic transmissions during 1-year follow-up. Secondary objectives include total RF time and parameters of acute PV isolation efficacy (first-pass isolation, acute reconnections and dormant conduction).
Status | Completed |
Enrollment | 304 |
Est. completion date | December 30, 2023 |
Est. primary completion date | April 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Paroxysmal or persistent atrial fibrillation. - Currently accepted class I or II indication for ablation according to practice guidelines: symptomatic arrhythmia, failure of at least 1 antiarrhythmic drug or patient's manifest preference of ablation instead of drugs. - Age > 18 years. - Acceptance of informed consent. Exclusion Criteria: - Previous pulmonary veins ablation of any type. - Permanent atrial fibrillation or long-standing persistent AF (>1 year). - Heart surgery <3 months before ablation. - Coronary revascularization of any type <3 months before ablation. - Myocardial infarction or acute coronary syndrome < 3 months before ablation. - Stroke or transient cerebral ischaemic attack < 3 months before ablation. - Persistent left atrial thrombus. - Contraindication for anticoagulation. - Absolute indication of double antiplatelet drugs. - Complex congenital heart disease, corrected or not. - Any clinical situation absolutely precluding an interventional procedure. |
Country | Name | City | State |
---|---|---|---|
Spain | University Hospital La Paz, Department of Cardiology | Madrid |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario La Paz |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety: incidence of esophageal thermal lesions | Incidence of thermal esophageal lesions evaluated by endoscopy | 24 hours after ablation (permissible up to 72 hours after ablation) | |
Primary | Efficacy: recurrence of atrial arrhythmias | Recurrences of any atrial arrhythmias >30 seconds during 1-year follow-up evaluated by daily transtelephonic ECG transmissions (at least 1 ECG/day and additional transmissions whenever the patient perceives arrhythmia-related symptoms). | 1 year | |
Primary | Total radiofrequency time | Total radiofrequency time required for complete pulmonary veins isolation (included acute intraprocedural reconnections and dormant conduction). | during ablation procedure |
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