Systematic Workflow for Pentaspline Pulsed-field Ablation Optimization (SWEET P-PFA)
Systematic Workflow for Pentaspline Pulsed-field Ablation Optimization: Real-world Performance of the 12 cOmmandments (12-O) Strategy
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Madrid, Spain
- Hospital Universitario 12 de Octubre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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
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Pulmonary vein isolation with pentaspline PFA catheter with subsequent implementation of changes in workflow to increase long-term PVI durability
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Paroxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 2
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Pulmonary vein isolation with pentaspline PFA catheter with subsequent implementation of changes in workflow to increase long-term PVI durability
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Paroxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 3
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Pulmonary vein isolation with pentaspline PFA catheter with subsequent implementation of changes in workflow to increase long-term PVI durability
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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PVI durability (per vein)
Time Frame: 30-120 days after index PVI
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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.
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30-120 days after index PVI
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PVI durability (per patient)
Time Frame: 30-120 days after index PVI
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Co-primary efficacy endpoint
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30-120 days after index PVI
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Cardiac Major Adverse Events
Time Frame: 0 to 30 days following either the index or remapping procedures
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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.
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0 to 30 days following either the index or remapping procedures
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Workflow Optimization P-PFA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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