Pulsed Field Ablation (PFA) Versus Anti-Arrhythmic Drug (AAD) Therapy as a

Status Recruiting

Clinical Trial Summary

The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial treatment with anti-arrhythmic drugs.

Clinical Trial Description

This is a prospective, randomized, multi-center, global, pivotal Investigational device exemption (IDE) study. Subjects with persistent atrial fibrillation will be randomized to either pulsed field ablation (PFA) or Versus Anti-Arrhythmic Drug (AAD) treatment. Subjects randomized to PFA treatment will undergo percutaneous ablative pulmonary vein isolation (PVI) and left atrial posterior wall isolation (PWI) using the FARAWAVE™ PFA Catheter (first-line ablation cohort). Subjects randomized to AAD treatment will be prescribed and monitored in accordance with local clinical practice and already established guideline-directed therapy for patients with persistent atrial fibrillation (AF). Cardioversion is recommended during the initiation of antiarrhythmic drugs for subjects who are not in sinus rhythm. In the case of clinical inefficacy, the AAD dose will be up-titrated to the maximum tolerated dose. Thereafter, a change to a second or to a third AAD should be undertaken, insofar as the subject remains within the blanking period, with the goal to completely suppress AF episodes ≥ 30 seconds in duration. It is advisable to perform cardioversion with each dose titration or when changing the AAD regimen. If AAD treatment is proven to be ineffective or intolerable outside of the blanking period, subjects can undergo subsequent ablation therapy and be considered part of the "delayed ablation cohort". ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06096337
Study type	Interventional
Source	Boston Scientific Corporation
Contact	Boston Scientific
Phone	800-272-1001
Email	monitortroubleshooting@cdxbsci.com
Status	Recruiting
Phase	N/A
Start date	December 28, 2023
Completion date	December 30, 2027

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pulsed Field Ablation (PFA) Versus Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation — AVANT GUARD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms