Durability of Pulmonary Vein Isolation With Farapulse System Using Minimal Fluoroscopy

NCT07752771 | Completed

• 1 other identifier: 38555-2/KKJOG/2025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• PVI durability at three months

  At three months, we perform an invasive left atrial remap. The primary outcome will be pulmonary vein reconnection. The outcome measure will be the risk (incidence) of pulmonary vein reconnection. The number of reconnected pulmonary veins will be collected.

  3 months

Study Arms (1)

Ablation

EXPERIMENTAL

Single-arm

Device: catheter ablation

Interventions

catheter ablation DEVICE

Pulmonary vein isolation using Farapulse system with Faraview mapping

Ablation

Eligibility Criteria

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

You may qualify if:

• Symptomatic paroxysmal AF
• Age \>18 years
• Willingness to sign the informed consent form

You may not qualify if:

• Contraindication to ablation
• Contraindication of long-term anticoagulation
• Persistent AF
• History of typical or atypical flutter
• History of PVI
• History of cardiac surgery
• Contraindication of cardiac MRi examination
• Pregnancy
• Active malignancy
• Life expectancy \<1 year
• Valvular AF
• Reversible cause of AF (e.g. hyperthyroidism).

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University

Budapest, Pest County, 1122, Hungary

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: August 7, 2026
• Study Start: April 14, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 7, 2026

Record last verified: 2025-12

Locations

HU (1)