Fluoroscopy-only versus electroanatomic mapping for pulmonary vein isolation using a balloon pulsed-field ablation catheter
Comparison of Fluoroscopy-only vs. Electroanatomic Mapping Strategies for Pulmonary Vein Isolation With Balloon-based Pulsed-field Ablation
This trial will test whether adding electroanatomic mapping to standard fluoroscopy helps adults with paroxysmal or persistent atrial fibrillation get more durable pulmonary vein isolation when treated with a balloon-based pulsed-field ablation catheter.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario 12 de Octubre Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT07118046 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized study will enroll 96 consecutive adults with paroxysmal or persistent atrial fibrillation undergoing first-time pulmonary vein isolation with an octaspline balloon-based pulsed-field ablation catheter. After a 10-case run-in per operator, patients are randomized 1:1 to either a fluoroscopy-only workflow or the same fluoroscopy workflow with added electroanatomic mapping. Procedures are performed under deep sedo-analgesia and every patient undergoes systematic invasive remapping of the left atrium and pulmonary veins at least 30 days after the index ablation. The trial is conducted at University Hospital 12 de Octubre in Madrid with IRB approval and GDPR-compliant data handling.
Who should consider this trial
Good fit: Adults (age ≥18) with paroxysmal or persistent atrial fibrillation who have a clinical indication for first-time pulmonary vein isolation and can attend the required procedures and follow-up remapping are ideal candidates.
Not a fit: Patients with prior pulmonary vein isolation or left atrial linear ablation, left atrial thrombus, contraindication to heparin, planned or current pregnancy, severe frailty or life expectancy under one year, or those needing ablations beyond PVI are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could identify a guidance approach that yields more durable pulmonary vein isolation and streamline procedural workflow for patients undergoing balloon pulsed-field ablation.
How similar studies have performed: Balloon-based pulsed-field ablation has shown promising acute pulmonary vein isolation results in prior work, but randomized data directly comparing fluoroscopy-only versus electroanatomic mapping guidance are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Madrid, Madrid
- University Hospital 12 de Octubre — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Daniel Rodriguez, MD PhD — University Hospital 12 de Octubre
- Study coordinator: Daniel Rodriguez, MD, PhD
- Email: daniel.rodriguez.mnz@gmail.com
- Phone: +34917792456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.