Safety and effectiveness of a novel dual-energy radiofrequency/pulsed field ablation catheter: 12-month results of the FlexPulse study.

In 30 seconds

The FlexPulse study was a global, prospective, single-arm, multicentre clinical trial evaluating a flexible-tip catheter that delivers radiofrequency and pulsed-field energy in people with symptomatic, drug-refractory paroxysmal atrial fibrillation. All 180 participants underwent ablation, with pulmonary vein isolation achieved in every case. The predefined safety-event rate within 7 days was 1.7%. At 12 months, 74.6% met the composite effectiveness endpoint, which included freedom from arrhythmia recurrence, repeat ablation, antiarrhythmic drug escalation or cardioversion. The findings support the catheter’s safety and effectiveness in this study population, without a randomised comparator.

Key findings

• Pulmonary vein isolation was achieved in all 180 participants; adjunctive non-pulmonary-vein ablation was performed in 37.2% (67/180).
• The primary safety endpoint event rate was 1.7%.
• At 12 months, 74.6% met the composite effectiveness endpoint; freedom from documented AF/AFL/AT recurrence was 77.4% (92.6% without weekly transtelephonic monitoring).
• Among 15 participants undergoing repeat ablation after the blanking period, 79.7% (47/59) of pulmonary veins remained durably isolated.

Why it matters

The study provides 12-month clinical and procedural outcomes for a catheter combining radiofrequency and pulsed-field energy in drug-refractory paroxysmal atrial fibrillation. The reported safety events, arrhythmia outcomes and durability findings can inform understanding of this approach, while the single-arm design means the results do not establish comparative benefit over other ablation strategies.

What to keep in mind

The study was single-arm, so it cannot establish comparative effectiveness. The reported primary safety endpoint covered only the first 7 days after ablation.