NCT06706518

Systematic Workflow for Pentaspline Pulsed-field Ablation Optimization

Systematic Workflow for Pentaspline Pulsed-field Ablation Optimization: Real-world Performance of the 12 cOmmandments (12-O) Strategy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 118 (actual)
• Sponsor: Daniel Rodríguez Muñoz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

While radiofrequency and cryoballoon ablation have shown high rates of pulmonary vein reconnection in patients undergoing repeat electrophysiological evaluation for AF recurrence, early evaluations demonstrated a remarkably high rate of durable PVI with pentaspline pulsed field ablation (P-PFA). These observations suggested that PFA could mitigate the historical limitations of thermal ablation related to late PV reconnection and positioned the technology as a potentially robust solution for long-term lesion durability. However, real-world experience including data from large volume centers beyond initial learning curve, has revealed a non-negligible incidence of reconnections, comparable to those historically observed with thermal ablation and persisting even in the most contemporary datasets. These findings highlight the need to optimize procedural strategies to maximize lesion durability while maintaining procedural efficiency. Although fluoroscopic guidance remains standard practice in many centers, the adoption of intracardiac echocardiography (ICE) and electroanatomic mapping (EAM) to support device navigation is increasing, with the potential to improve lesion quality at the expense of greater complexity and resource utilization.

Detailed description

The primary objective of this study is the comparison of pulmonary vein isolation (per vein and per patient) between different workflow strategies using the P-PFA catheter. To assess that, patients will undergo invasive left atrial remapping at least 30 days after the initial procedure. Secondary objectives are efficacy and safety outcomes. Patient demographic variables will be collected, preserving the anonymity of the data by assigning a specific code for the study and not linked to the patient's medical history number or other identifying data.

Conditions

• Atrial Fibrillation (Paroxysmal)
• Atrial Fibrillation (AF)
• Ablation of Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Single-shot ablation technologies	Pulmonary vein isolation with pentaspline PFA catheter with subsequent implementation of changes in workflow to increase long-term PVI durability

Timeline

• Start date: 2023-08-17
• Primary completion: 2025-10-04
• Completion: 2025-11-04
• First posted: 2024-11-26
• Last updated: 2026-03-27

Locations

1 site across 1 country: Spain