Atrial Fibrillation (Paroxysmal)SWEET P-PFANCT06706518
Systematic Workflow for Pentaspline Pulsed-field Ablation Optimization
An observational study of Atrial Fibrillation (Paroxysmal) and Atrial Fibrillation (AF), run by Daniel Rodríguez Muñoz at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (Paroxysmal), Atrial Fibrillation (AF), Ablation of Atrial Fibrillation
- What is being tested?
- Single-shot ablation technologies
- Type of treatment
- Surgery or procedure
- How many people
- 118 participants
- Where
- 1 siteSpain
- Study dates
- 17 Aug 2023to 4 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing PVI with a diagnosis of paroxysmal or persistent AF recruited in single tertiary university hospital: Hospital 12 de Octubre
Who may be able to join
- Patients >18 years old, with a diagnosis of paroxysmal or persistent AF and a clinical indication to undergo PVI were included
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation (Paroxysmal), Atrial Fibrillation (AF), Ablation of Atrial Fibrillation
- Being tested
- Single-shot ablation technologies
- Keywords
- Pulmonary Vein ablation, Atrial Fibrillation, SWEET Strategy
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-shot ablation technologiesProcedure or surgery
Pulmonary vein isolation with pentaspline PFA catheter with subsequent implementation of changes in workflow to increase long-term PVI durability
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Procedure: Single-shot ablation technologies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30-120 days after index PVI
PVI durability (per patient)
Co-primary efficacy endpoint
Measured: 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.
Measured: 0 to 30 days following either the index or remapping procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start17 Aug 2023
- Primary completion4 Oct 2025
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (Paroxysmal)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Rodríguez Muñoz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Rodríguez Muñoz, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706518
- Sponsor's protocol ID
- Workflow Optimization P-PFA
- Acronym
- SWEET P-PFA
- Status last verified
- Mar 2026
- First submitted
- 25 Nov 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Workflow for Pentaspline Pulsed-field Ablation Optimization: Real-world Performance of the 12 cOmmandments (12-O) Strategy
- ClinicalTrials.gov ID
- NCT06706518
- Acronym / sponsor ID
- SWEET P-PFA / Workflow Optimization P-PFA
- Conditions
- Atrial Fibrillation (Paroxysmal), Atrial Fibrillation (AF), Ablation of Atrial Fibrillation
- Keywords
- Pulmonary Vein ablation, Atrial Fibrillation, SWEET Strategy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Daniel Rodríguez MuñozUniversity, hospital or other
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 4 Oct 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paroxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 1 | – | Procedure: Single-shot ablation technologiesPatients >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 | – | Procedure: Single-shot ablation technologiesParoxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 2 |
| Paroxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 3 | – | Procedure: Single-shot ablation technologiesParoxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing PVI with a diagnosis of paroxysmal or persistent AF recruited in single tertiary university hospital: Hospital 12 de Octubre
Key inclusion criteria (1 listed)
- Patients >18 years old, with a diagnosis of paroxysmal or persistent AF and a clinical indication to undergo PVI were included
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-shot ablation technologiesPulmonary vein isolation with pentaspline PFA catheter with subsequent implementation of changes in workflow to increase long-term PVI durability | Procedure or surgery | 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 |
Primary outcome
PVI durability (per vein)
Time frame: 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)
Time frame: 30-120 days after index PVI
Co-primary efficacy endpoint
Cardiac Major Adverse Events
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (Paroxysmal) and Atrial Fibrillation (AF), run by Daniel Rodríguez Muñoz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PVI durability (per vein) (time frame: 30-120 days after index PVI). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.