Systematic Workflow for Pentaspline Pulsed-field Ablation Optimization

NCT06706518 | Completed

• 1 other identifier: Workflow Optimization P-PFA
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Pulmonary Vein ablation; Atrial Fibrillation; SWEET Strategy

Outcome Measures

Primary Outcomes (3)

• PVI durability (per vein)

  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.

  30-120 days after index PVI

• PVI durability (per patient)

  Co-primary efficacy endpoint

  30-120 days after index PVI

• Cardiac Major Adverse Events

  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.

  0 to 30 days following either the index or remapping procedures

Study Arms (3)

Paroxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 1

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

Procedure: Single-shot ablation technologies

Paroxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 2

Paroxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 2

Procedure: Single-shot ablation technologies

Paroxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 3

Paroxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 3

Procedure: Single-shot ablation technologies

Interventions

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

Paroxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 1; Paroxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 2; Paroxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing PVI with a diagnosis of paroxysmal or persistent AF recruited in single tertiary university hospital: Hospital 12 de Octubre

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daniel Rodríguez Muñoz: lead

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cardiologist, Head of Cardiac Electrophysiology

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 26, 2024
• Study Start: August 17, 2023
• Primary Completion: October 4, 2025
• Study Completion: November 4, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)