Comparative Intra-procedural Evaluation of Farapulse and FARAWAVE Nav Catheters

NCT07130773 | Recruiting DMC

• 2 other identifiers: CCT2025-FaraRadiationBASEC-ID 2025-01638
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The FARAPULSE PFA catheter (Boston Scientific), a first-generation Pulsed Field Ablation (PFA) tool, has demonstrated good performance in isolating pulmonary veins (PV). Several centers, including ours, utilize pre-procedural computer tomography (CT) to evaluate individual pulmonary vein anatomy and optimize ablation planning. However, these imaging modalities are costly. Additionally, CT imaging exposes patients to radiation, and introduce significant logistical challenges to the procedural workflow. The FARAWAVE Nav PFA catheter, a second-generation device, integrates magnetic navigation capabilities with detailed mapping and PFA therapy into a single tool. This system leverages the FARAVIEW Software Module, offering tailored mapping solutions visualized on the FARAPULSE PFA system, including the creation of voltage and activation maps. These features address the limitations of the first-generation FARAPULSE catheter and have the potential to improve procedural accuracy and the durability of pulmonary vein isolation. Moreover, they may obviate the need for pre-procedural CT, thereby reducing costs and minimizing patient radiation exposure. Our study evaluates whether the FARAWAVE Nav catheter, used without pre-ablation CT, allows for a reduction in fluoroscopy time and overall patient radiation exposure compared to the conventional workflow with the FARAPULSE catheter. Furthermore, we will assess procedural time, costs, number of PFA applications, and AF recurrence-free survival

Conditions

Atrial Fibrillation (AF); Atrial Fibrillation Ablation; Pulsed Field Ablation

Keywords

pulsed filed ablation; atrial fibrillation; ablation; pulmonary vein isolation; electroanatomical map; ionizing radiation; farapulse; farawave nav

Outcome Measures

Primary Outcomes (1)

• Fluoroscopy time

  The primary outcome of this investigation is fluoroscopy time, measured in minutes during the pulmonary vein isolation procedure. This outcome was chosen because it directly reflects the amount of radiation exposure experienced by the patient and is a critical measure of procedural efficiency and safety. For patients undergoing PVI plus additional left or right atrial ablations (planned or unplanned) the fluoroscopy time will be counted until the last application of the PVI. Fluoroscopic times will be compared between groups using the unpaired Student t test. The mean difference and 95%CI will be computed. In case of skewness, data will be log-transformed before entering the test. In this the mean difference on the log scale and the ratio on the original scale will be presented, both with 95%CI.

  immediately after the procedure

Secondary Outcomes (7)

• Total Patient Radiation Load

  immediately after the procedure

• Procedure Time

  immediately after the procedure

• Left Atrial Dwelling Time

  immediately after the procedure

• Fluoroscopy Time After Transseptal Puncture

  immediately after the procedure

• Number of PFA Applications

  immediately after the procedure

Other Outcomes (1)

• Procedural Costs

  immediately after the procedure

Study Arms (2)

Intervention

EXPERIMENTAL

FARAWAVE Nav without pre-ablation CT

Device: Second-generation FARAWAVE Nav catheter without the use of pre-ablation CT

Control

ACTIVE COMPARATOR

FARAPULSE with pre-ablation CT

Device: FARAPULSE with pre-ablation CT

Interventions

Second-generation FARAWAVE Nav catheter without the use of pre-ablation CT DEVICE

FARAWAVE Nav without pre-ablation CT (Intervention Group, n = 29) Description of the investigation-specific intervention: Participants in the intervention group will undergo pulmonary vein isolation (PVI) using the second-generation FARAWAVE Nav pulsed field ablation (PFA) catheter without the use of pre-ablation CT imaging. The FARAWAVE Nav catheter integrates magnetic navigation and electroanatomical mapping capabilities, allowing real-time visualization of left atrial anatomy and electrical signals. Energy delivery is based on non-thermal pulsed electric fields (irreversible electroporation), specifically targeting myocardial tissue while sparing surrounding structures.

Intervention

FARAPULSE with pre-ablation CT DEVICE

FARAPULSE with pre-ablation CT (Control Group, n = 29) Description of the investigation-specific intervention: Participants in the control group will undergo pulmonary vein isolation (PVI) using the first-generation FARAPULSE pulsed field ablation (PFA) catheter. All patients in this group will undergo pre-procedural cardiac CT imaging to evaluate pulmonary vein anatomy and assist in procedural planning. The FARAPULSE catheter delivers non-thermal pulsed electric fields for selective myocardial ablation, aiming to achieve electrical isolation of the pulmonary veins.

Control

Eligibility Criteria

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

You may qualify if:

• Atrial fibrillation (AF) documented on a 12-lead ECG, Holter monitor, or implantable cardiac device.
• Candidate for ablation according to current atrial fibrillation guidelines.
• Age ≥18 years at the time of informed consent.
• Signed informed consent obtained

You may not qualify if:

• Previous left atrial ablation or left atrial surgery.
• Presence of intracardiac thrombus.
• Persistent atrial fibrillation lasting \>3 years.
• Severe mitral regurgitation or moderate-to-severe mitral stenosis.

Sponsors & Collaborators

• Cardiocentro Ticino: lead

Study Sites (1)

Cardiocentro Ticino - Ente Ospedaliero Cantonale

Lugano, Canton Ticino, 6900, Switzerland

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Marco Bergonti, MD PhD

CONTACT

+41 (0) 91 811 51 11; bergmar21@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 19, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)