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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| Paroxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 2 | Paroxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 2 |
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| Paroxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 3 | Paroxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 3 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing PVI with a diagnosis of paroxysmal or persistent AF recruited in single tertiary university hospital: Hospital 12 de Octubre
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario 12 de Octubre | Madrid | Spain |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |