Skip to main content
OpenTrials
Completed

NCT Number: NCT06706518

Systematic Workflow for Pentaspline Pulsed-field Ablation Optimization

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation (Paroxysmal) Ablation of Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Atrial Fibrillation (AF) Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario 12 de Octubre

Madrid, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients >18 years old, with a diagnosis of paroxysmal or persistent AF and a clinical indication to undergo PVI were included

Exclusion criteria

  • prior PVI or left atrial linear ablation
  • severe frailty or life expectancy <1 year
  • unwillingness or inability to provide informed consent
  • ablation at sites beyond PVI
  • contraindication or intolerance to heparin
  • presence of left atrial thrombus
  • congenital heart disease
  • pregnancy, ongoing or planned in the following 6 months.

Treatment and study plan

Single-shot ablation technologies

Procedure

Pulmonary vein isolation with pentaspline PFA catheter with subsequent implementation of changes in workflow to increase long-term PVI durability

Primary outcomes

  1. PVI durability (per vein)

    Time frame: 30-120 days after index PVI

    Co-primary efficacy endpoint. Patients will unergo a second procedure for re-mapping of the pulmonary veins no earlier than 30 days after the initial procedure. This procedure will check if the pulmonary veins remain isolated.

  2. PVI durability (per patient)

    Time frame: 30-120 days after index PVI

    Co-primary efficacy endpoint

  3. Cardiac Major Adverse Events

    Time frame: 0 to 30 days following either the index or remapping procedures

    Primary safety endpoint is a composite of major adverse events (AEs) including cardiac perforation, tamponade, stroke or transient ischemic attack, peripheral thromboembolic event, vascular complications requiring intervention, myocardial infarction or death occurring in the first 30 days following either the index or remapping procedures.

Sponsors and collaborators

Lead sponsor

Daniel Rodríguez Muñoz

Other

Registry information

Official study title

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

Acronym: SWEET P-PFA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.