Boston Scientific’s Global Pulsed Field Ablation Trial Targets Persistent Atrial Fibrillation Growth

Boston Scientific (BSX) announced an update on their ongoing clinical study.

Study Overview
This global Boston Scientific trial, officially titled “A Global Randomized Trial Comparing Pulsed Field Ablation of Pulmonary Veins Plus Extra-PV Sources Utilizing Electrographic Flow Mapping Versus Pulmonary Veins Plus Posterior Wall in Persistent Atrial Fibrillation Patients,” aims to test a new way to treat persistent atrial fibrillation. The study compares two pulsed field ablation approaches to see if a targeted mapping method can match or improve safety and effectiveness versus a more conventional ablation pattern. The outcome could influence future standards of care for patients whose atrial fibrillation does not respond to drugs.

Intervention/Treatment
The trial tests device-based heart ablation systems from Boston Scientific. Both arms use the FARAPULSE Pulsed Field Ablation System with the Opal HDx mapping platform to isolate the pulmonary veins, while the treatment arm also uses the FARAPOINT Pulsed Field Ablation System and the OptiMap mapping system to target extra atrial fibrillation sources identified by electrographic flow mapping. The goal is to deliver precise, tissue-selective ablation that improves rhythm control while limiting damage to nearby structures.

Study Design
This is an interventional, randomized trial with patients assigned to one of two treatment paths in parallel. One group receives pulsed field ablation of the pulmonary veins plus ablation of the left atrial posterior wall, while the other group receives pulmonary vein ablation plus focused ablation of mapped extra sources. There is no traditional masking, but operators in the control arm are blinded to certain mapping information to keep comparisons fair. The main purpose is treatment, with safety and rhythm control as key endpoints.

Study Timeline
The study was first submitted on September 15, 2025, signaling the formal regulatory and operational start of the program. It is currently recruiting, which means enrollment and procedures are underway but primary outcome data are not yet available. The latest update was filed on December 22, 2025, indicating active management of the protocol and public information. Primary completion and final completion dates have not been detailed yet, so investors should expect key readouts to be several years out, consistent with typical cardiac rhythm follow-up periods.

Market Implications
For investors, this trial underscores Boston Scientific’s push to lead in pulsed field ablation for persistent atrial fibrillation, a large and underpenetrated segment. If the electrographic flow mapping strategy proves at least as effective and safe as the posterior wall approach, it could strengthen the FARAPULSE ecosystem, support premium pricing, and drive share gains against competitors in electrophysiology, including Medtronic, Abbott, and Johnson & Johnson’s Biosense Webster. Positive interim signals or smooth execution may support sentiment and valuation multiples for BSX, while delays, safety concerns, or weak efficacy could temper enthusiasm for pulsed field ablation in more complex atrial fibrillation. Given the early stage, the study is more about long-term growth optionality than near-term earnings, but it adds to the narrative that pulsed field ablation is moving beyond simple cases into more durable, higher-value procedures.

The study is currently ongoing and updated, with full details available on the ClinicalTrials.gov portal.

To learn more about BSX’s potential, visit the Boston Scientific drug pipeline page.