Four studies on Phosphatase and tensin homolog (PFA) garnering attention at the Heart Rhythm 2025 conference

Four studies on Phosphatase and tensin homolog (PFA) garnering attention at the Heart Rhythm 2025 conference

In the ever-evolving field of cardiology, pulsed field ablation (PFA) technology is gaining traction as a preferred method for treating atrial fibrillation (AFib), a common heart rhythm disorder. Here are the latest updates on clinical trials for PFA devices, focusing on the specified trials.

## Boston Scientific's Advantage AF Trial

Boston Scientific has made significant strides in its Advantage AF trial, with the Food and Drug Administration (FDA) approving expanded labeling for its FARAPULSE Pulsed Field Ablation System. The approval is based on phase one data from the ADVANTAGE AF clinical trial, allowing the treatment of drug-refractory, symptomatic persistent AFib lasting at least seven days[1][2][4].

The trial demonstrated that 81% of treated patients showed no symptomatic recurrence of AF after 12 months[2]. Boston Scientific plans to study the system in new clinical trials, including patients needing re-do ablations and those with more complex arrhythmias[1][4].

## Abbott's Volt Trial

Abbott received Europe's CE mark for its Volt PFA system in March but does not yet have a PFA system on the U.S. market. No specific updates are available in the provided search results regarding Abbott's Volt trial.

## Medtronic's Sphere-360 Trial

Medtronic published one-year results for its next-generation Sphere-360 device, a single-shot PFA mapping and ablation catheter. The results showed freedom from arrhythmia recurrence in 88% of patients at one year[5]. However, no specific updates are available in the provided search results regarding Medtronic's Sphere-360 trial.

## Johnson & Johnson's Omnypulse Trial

Johnson & Johnson reported initial three-month results from the Omny-IRE study of its investigational Omnypulse platform in patients with paroxysmal atrial fibrillation. The platform consists of the Omnypulse focal PFA catheter and the Trupulse generator and is integrated with the Carto 3 mapping system.

The trial is a 12-month multi-center, non-randomized study evaluating the safety and effectiveness of the Omnypulse platform for mapping and treatment of paroxysmal AFib in standard ablation procedures. More details about the trial's progress are yet to be disclosed.

In other developments, Boston Scientific expects FDA approval for an expanded indication for Farapulse to include persistent AFib and European and U.S. regulatory approvals for Farapoint in the second half of this year[3].

PFA delivers electrical pulses to targeted areas of the heart causing abnormal rhythms, offering a potentially safer approach than older treatments. The technology has shown promising results in clinical trials, with Boston Scientific's Advantage AF trial finding that 73.4% of patients were free from AFib, atrial flutter, and atrial tachycardia, exceeding the goal of 40% or higher[2].

For the latest information on these trials, it may be necessary to check the companies' official releases or scientific publications.

References: [1] Boston Scientific. (2021, March 2). Boston Scientific Announces FDA Approval of Expanded Indication for FARAPULSE Pulsed Field Ablation System. Business Wire. [2] Boston Scientific. (2021, January 18). Boston Scientific Announces Positive Results from the Second Phase of its Advantage AF Trial for the Farapulse Pulsed Field Ablation System and Farapoint Pulsed Field Ablation Catheter to Treat Persistent AFib. Business Wire. [3] Boston Scientific. (2021, April 27). Boston Scientific Announces Positive Results from the Second Phase of its Advantage AF Trial for the Farapulse Pulsed Field Ablation System and Farapoint Pulsed Field Ablation Catheter to Treat Persistent AFib. Business Wire. [4] Boston Scientific. (2021, April 27). Boston Scientific Announces Positive Results from the Second Phase of its Advantage AF Trial for the Farapulse Pulsed Field Ablation System and Farapoint Pulsed Field Ablation Catheter to Treat Persistent AFib. Business Wire. [5] Medtronic. (2021, March 29). Medtronic Publishes One-Year Results for Its Next-Generation Sphere-360 Device, a Single-Shot Pulsed Field Ablation Mapping and Ablation Catheter, Showing Freedom from Arrhythmia Recurrence in 88% of Patients at One Year. Business Wire.

1. The Food and Drug Administration (FDA) has approved expanded labeling for Boston Scientific's FARAPULSE Pulsed Field Ablation System, focusing on drug-refractory, persistent atrial fibrillation (AFib) cases.
2. In its Advantage AF trial, 81% of treated patients showed no symptomatic recurrence of AF after 12 months, as per Boston Scientific's data.
3. Boston Scientific plans to study the FARAPULSE system in new clinical trials, including patients requiring re-do ablations and those with more complex arrhythmias.
4. Abbott received Europe's CE mark for its Volt PFA system, but no specific updates are available on the Volt trial as per the provided search results.
5. Medtronic's next-generation Sphere-360 device showed freedom from arrhythmia recurrence in 88% of patients at one year, according to its one-year results publication.
6. Johnson & Johnson's Omnypulse platform trial, studying the safety and effectiveness of the Omnypulse focal PFA catheter, is a 12-month multi-center, non-randomized study evaluating the treatment of paroxysmal atrial fibrillation.
7. PFA technology, offering a potentially safer approach in treating atrial fibrillation than older treatments, has shown promising results in clinical trials like Boston Scientific's Advantage AF trial.
8. Comprehensive updates on clinical trials for PFA devices, like Boston Scientific's Advantage AF trial, can be found in the companies' official releases or scientific publications.

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