Ablation of Atrial Fibrillation, Atrial Fibrillation (AF), Atrial Fibrillation (Paroxysmal)
Conditions
Keywords
Pulmonary Vein ablation, Atrial Fibrillation, SWEET Strategy
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.
Interventions
PROCEDURESingle-shot ablation technologies
Pulmonary vein isolation with pentaspline PFA catheter with subsequent implementation of changes in workflow to increase long-term PVI durability
Sponsors
Daniel Rodríguez Muñoz
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PVI durability (per vein) | 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. |
| PVI durability (per patient) | 30-120 days after index PVI | Co-primary efficacy endpoint |
| Cardiac Major Adverse Events | 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. |
Countries
Spain
Outcome results
None listed