Comparative Intra-procedural Evaluation of Farapulse and FARAWAVE Nav Catheters
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCardiocentro Ticino
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Second-generation FARAWAVE Nav catheter without the use of pre-ablation CT
DeviceFARAWAVE 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.
FARAPULSE with pre-ablation CT
DeviceFARAPULSE 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.
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
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.
Time frame
immediately after the procedureSecondary outcomes
1
Total Patient Radiation Load
Total patient radiation load (cGy·cm²): to assess overall radiation exposure, including both imaging and intra-procedural sources. In case a patient randomized to the control group has already undergone a cardiac CT scan for another clinical reason in the past, the scan will not be repeated for ethical reasons. However, for the purpose of radiation dose calculation, the average radiation dose of a cardiac CT scan will be added as if the scan had been performed. Conversely, if a patient in the intervention group has previously undergone a cardiac CT scan, the operator will not review this scan prior to the procedure, and the corresponding radiation dose will not be included in the calculation. Analysis: same as the primary endpoint
Time frame
immediately after the procedure2
Procedure Time
Procedure time (minutes): to evaluate procedural efficiency from catheter insertion to removal. For patients undergoing PVI plus additional left or right atrial ablations (planned or unplanned) the procedure time will be counted until the last application of the PVI. Analysis: same as the primary endpoint
Time frame
immediately after the procedure3
Left Atrial Dwelling Time
Left atrial dwelling time (minutes): to assess the duration of catheter presence in the left atrium, which is associated with thromboembolic and procedural risks. Analysis: same as the primary endpoint.
Time frame
immediately after the procedure4
Fluoroscopy Time After Transseptal Puncture
Fluoroscopy time after transseptal puncture (minutes): to determine radiation exposure specifically during the left atrial portion of the procedure.
Time frame
immediately after the procedureOther outcomes
1
Procedural Costs
Procedural costs: Pre-procedural imaging and procedural costs \[Cost of CT scan, FARAPULSE Catheter, FARAVEIW Catheter.\] The same analysis as for the primary endpoint will be used. In addition the ICER - incremental cost-effectiveness ratio - will be computes as the ratio of the difference in costs over the difference in effect as measures for the primary endpoint
Time frame
immediately after the procedureSponsors and contacts
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Source ClinicalTrials.gov