Comparing two pulsed field ablation catheters for atrial fibrillation treatment
Tests a newer heart catheter without pre-procedure CT scans in adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Comparative Intra-procedural Evaluation of Farapulse and FARAWAVE Nav Catheters
Key facts
- Where
- Lugano, SwitzerlandSee the site
Where in Switzerland
- Cardiocentro Ticino - Ente Ospedaliero CantonaleLugano, SwitzerlandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cardiocentro Ticino
- Trial code
- NCT07130773
- Record updated
- 19 March 2026
- Original description
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.Read full original descriptionShow less
Procedural Comparative Evaluation of Pulmonary Vein Isolation Using the FARAWAVE Nav PFA Catheter Without Pre-Ablation Computer Tomography (CT) vs. Conventional Farapulse With Pre-Ablation CT: A Single Centre Open-label, Randomized Controlled 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
Inclusion: 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.
Exclusion: Previous left atrial ablation or left atrial surgery; Pregnancy (all women under 50 years undergo an HCG blood test prior to inclusion to exclude pregnancy); Persistent atrial fibrillation lasting >3 years; Presence of intracardiac thrombus; Severe mitral regurgitation or moderate-to-severe mitral stenosis.