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Durability of Pulmonary Vein Isolation With Farapulse System Using Minimal Fluoroscopy

NCT07752771 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-07

No results posted yet for this study

Summary

Objective: To evaluate the feasibility, acute, and three-month efficacy and safety of near-zero fluoroscopy PVI performed with the Farapulse system (Faravawe catheter, Faradrive sheath, Faraview module).

Primary hypothesis: High durability of PVI is achievable with minimal fluoroscopy PVI, using ICE-guided transseptal puncture and Farapulse system.

Study Design: Single-center, prospective, single-arm study. Investigator-initiated study.

Research period, expected enrollment rate: The planned research period starts in the third quarter of 2024. The expected enrollment rate is 4 patients/week. The enrollment and performance of the index procedure are expected to be completed within 1.5 - 2 months, and then three more months are required before the remap procedure.

Procedure: Standard PVI using Farapulse system and Faraview module. Follow-up: Invasive left atrial remap 3 months after the procedure. Imaging: CT and MRi scans to detect pulsed-field ablation scars before the FU procedure.

Endpoints:

* Primary endpoint: PVI durability at three months, detected by invasive left atrial remap, on a per PV basis.
* Secondary endpoints:

* Continuity and size of the scar caused by the index ablation, detected on the cardiac MRI and CT before the remap (to compare it with the remapping data)
* Door-to-door time (total time spent in the EP lab)
* Skin-to-skin procedure time: time from the first femoral vein puncture to the removal of all sheaths
* Left atrial dwelling time: time from inserting the long sheath in the left atrium to the sheath removal from the left atrium
* Ablation time: time from the first until the last ablation
* Fluoroscopy time and dose
* Occurrence of any adverse events related to the procedure during the hospital stay at the 3 months remap the procedure

Conditions

  • Atrial Fibrillation (AF)
  • Pulsed-field Ablation

Interventions

DEVICE

catheter ablation

Pulmonary vein isolation using Farapulse system with Faraview mapping

Sponsors & Collaborators

  • Semmelweis University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-14
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Hungary

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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 NCT07752771 on ClinicalTrials.gov