Comparative Intra-procedural Evaluation of Farapulse and FARAWAVE Nav Catheters
Recruiting · NCT07130773 · Interventional (participants receive a specific treatment) · Lead sponsor: Cardiocentro Ticino
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Inclusion criteria
- 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 criteria
- 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.
- Pregnancy (all women under 50 years undergo an HCG blood test prior to inclusion to exclude pregnancy).
Where it is running
1 location listed.
- Cardiocentro Ticino - Ente Ospedaliero Cantonale - Lugano, Canton Ticino, Switzerland