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

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05970120` - A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter	N/A
Recruiting	`NCT05416086` - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study	N/A
Completed	`NCT03650556` - Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation	N/A
Recruiting	`NCT04085731` - Driver-guided Ablation of Persistent Atrial Fibrillatiom
Withdrawn	`NCT02344394` - Comparison of Hybrid Ablation and Pulmonary Vein Isolation Alone vs Hybrid Ablation With PVI Plus Catheter Ablation	N/A
Completed	`NCT01694563` - ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation	N/A
Terminated	`NCT01683045` - Efficacy and Safety Study of the Estech COBRA® Surgical System to Treat Patients With a History of Irregular Heart Beats	N/A
Active, not recruiting	`NCT03643224` - DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation	N/A
Withdrawn	`NCT05093868` - Electrographic Flow Mapping Validation in Patients With Persistent Atrial Fibrillation (EVAL AF)	N/A
Completed	`NCT05152966` - Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation(PersAFOne II)	N/A
Completed	`NCT05043883` - Automated Assessment of PVI Using a Novel EP Recording System	N/A
Completed	`NCT04022954` - HD Mapping of Atrial Fibrillation in Asia Pacific
Active, not recruiting	`NCT06124690` - Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas	N/A
Completed	`NCT06260670` - FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation	N/A
Not yet recruiting	`NCT05454111` - CARTO-Finder Guided Ablation Versus Multiscale Entropy Guided Ablation in Persistent Atrial Fibrillation	N/A
Active, not recruiting	`NCT05077670` - Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm
Withdrawn	`NCT03835338` - WATCHMAN for Concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation Rhythm	N/A
Completed	`NCT02275104` - Multimodal Image Processing Software to Guide Cardiac Ablation Therapy	N/A
Not yet recruiting	`NCT05565183` - Combined Study of ATrial Strain and Voltage by High Density Mapping in Young Patients With Atrial Fibrillation.	N/A
Completed	`NCT02274857` - Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures	N/A

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