NCT07130773Recruiting
Comparative Intra-procedural Evaluation of Farapulse and FARAWAVE Nav Catheters
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
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- First submitted
- 8 Aug 2025
- Start date
- Nov 2025
- Primary completion date
- Aug 2026
- Lead sponsor
- Cardiocentro Ticino
- Diseases
- Atrial fibrillation
- NCT number
- NCT07130773
What you commit to
- Study type: Interventional
- Planned participants: 58
- From Nov 2025 to the primary completion date, Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Age
- Persistent atrial fibrillation lasting \>3 years.
Other
- Presence of intracardiac thrombus.
- Severe mitral regurgitation or moderate-to-severe mitral stenosis.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardiocentro Ticino - Ente Ospedaliero Cantonale Coordinator of this site? Confirm its status | Lugano | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.