Comparison of Fluoroscopy-only vs. Electroanatomic Mapping Strategies for Pulmonary Vein Isolation With Balloon-based Pulsed-field Ablation
Recruiting · NCT07118046 · Interventional (participants receive a specific treatment) · Lead sponsor: Daniel Rodríguez Muñoz
View the official record on ClinicalTrials.gov →Interventions studied
Pulmonary vein isolation
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- ≥18 years old
- Diagnosed with paroxysmal or persistent AF
- Clinical indication to undergo PVI
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 or indication for additional electrophysiological study
- Contraindication or intolerance to heparin
- Presence of left atrial thrombus
- Congenital heart disease
- Pregnancy, ongoing or planned in the following 6 months
Where it is running
1 location listed.
- University Hospital 12 de Octubre - Madrid, Madrid, Spain