NCT06706518Completed
Systematic Workflow for Pentaspline Pulsed-field Ablation Optimization
Systematic Workflow for Pentaspline Pulsed-field Ablation Optimization: Real-world Performance of the 12 cOmmandments (12-O) Strategy
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 118 (actual)
- First submitted
- 25 Nov 2024
- Start date
- 17 Aug 2023
- Primary completion date
- 4 Oct 2025
- Lead sponsor
- Daniel Rodríguez Muñoz
- Diseases
- Atrial fibrillation
- NCT number
- NCT06706518
What you commit to
- Study type: Observational
- Participants enrolled: 118
- From 17 Aug 2023 to the primary completion date, 4 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- prior PVI or left atrial linear ablation
Other illness
- congenital heart disease
Other
- 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
- pregnancy, ongoing or planned in the following 6 months.
Who the study is looking for
- Patients \>18 years old, with a diagnosis of paroxysmal or persistent AF and a clinical indication to undergo PVI were included
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.