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Comparison of Fluoroscopy-only vs. Electroanatomic Mapping Strategies for Pulmonary Vein Isolation With Balloon-based Pulsed-field Ablation

NCT07118046 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-09-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Pulmonary vein isolation

Pulsed field ablation for pulmonary vein isolation in atrial fibrillation ablation

Sponsors & Collaborators

  • Daniel Rodríguez Muñoz

    lead OTHER

Principal Investigators

  • Daniel Rodriguez, MD PhD · University Hospital 12 de Octubre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-05
Primary Completion
2025-12-30
Completion
2026-03-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07118046 on ClinicalTrials.gov