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

NCT07118046 | Recruiting DMC

• 1 other identifier: PFA Balloon -SWEET Single Shot
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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

Atrial Fibrillation

Keywords

pulmonary vein isolation; atrial fibrillation; pulsed field ablation

Outcome Measures

Primary Outcomes (2)

• Durable PVI (per vein)

  proportion of pulmonary veins durably isolated (i.e.: more than 30 days after index procedure);

  30 days after index procedure

• Durable PVI (per patient)

  proportion of patients with all pulmonary veins durably isolated (i.e.: more than 30 days after index procedure);

  30 days after index procedure

Secondary Outcomes (2)

• Fluoroscopy exposure

  At index procedure

• PFA reversibility

  30 days after index procedure

Study Arms (2)

Fluoroscopy only

ACTIVE COMPARATOR

Fluoroscopy-only guidance throughout the procedure

Device: Pulmonary vein isolation

Fluoroscopy and electroanatomic mapping

EXPERIMENTAL

Both fluoroscopy and electroanatomic mapping guidance

Device: Pulmonary vein isolation

Interventions

Pulmonary vein isolation DEVICE

Pulsed field ablation for pulmonary vein isolation in atrial fibrillation ablation

Fluoroscopy and electroanatomic mapping; Fluoroscopy only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• Diagnosed with paroxysmal or persistent AF
• Clinical indication to undergo PVI

You may not qualify if:

• 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

Sponsors & Collaborators

• Daniel Rodríguez Muñoz: lead

Study Sites (1)

University Hospital 12 de Octubre

Madrid, Madrid, 28041, Spain

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Rodriguez, MD PhD

  University Hospital 12 de Octubre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Rodriguez, MD, PhD

CONTACT

+34917792456; daniel.rodriguez.mnz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All events related to the dual primary efficacy outcomes and primary safety outcome will be reviewed by an independent committee. These physicians will be responsible for reviewing the acute and chronic (\>30 days) left atrial maps. Their role will be to determine PVI status and to define the type of adverse event according to its severity and relevance to the study. This committee will consist of three electrophysiologists who will not participate in the ablation or remapping procedures and who will be blinded to the characteristics of the index procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD and Medical Doctor Consultant in Cardiac Electrophysiology, Principal Investigator

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: August 5, 2025
• Primary Completion: December 30, 2025
• Study Completion: March 30, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

ES (1)