Systematic Workflow for Pentaspline Pulsed-field Ablation Optimization: Real-world Performance of the 12 cOmmandments (12-O) Strategy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- Fluoroscopy time during ablation procedure (min)
Study Overview
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Fluoroscopy time during ablation procedure (min)
Time Frame: It is assessed through procedure time, measured in minutes
Co-primary efficacy endpoint
Cardiac Major Adverse Events
Time Frame: In the first 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.
Durable PVI effect
Time Frame: 30 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Daniel Rodríguez Muñoz
Cardiologist, Head of Cardiac Electrophysiology
Hospital Universitario 12 de Octubre