NCT07118046Recruiting
Comparison of Fluoroscopy-only vs. Electroanatomic Mapping Strategies for Pulmonary Vein Isolation With Balloon-based Pulsed-field Ablation
Source: ClinicalTrials.gov · Last updated 11 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
We designed a study to evaluate the impact of a two systematic strategies for PVI with the octaspline, balloon-based PFA (B-PFA) catheter. We hypothesized that the addition of electroanatomic guidance is non-superior to fluoroscopy-only guidance in achieving durable PVI.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 5 Aug 2025
- Start date
- 5 Aug 2025
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Daniel Rodríguez Muñoz
- Diseases
- Atrial fibrillation
- NCT number
- NCT07118046
What you commit to
- Study type: Interventional
- Planned participants: 96
- From 5 Aug 2025 to the primary completion date, 30 Dec 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 or indication for additional electrophysiological study
- 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
- ≥18 years old
- Diagnosed with paroxysmal or persistent AF
- Clinical indication to undergo PVI
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 |
|---|---|---|---|
| University Hospital 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.