Actively Recruiting
Procedural Comparative Evaluation of Pulmonary Vein Isolation Using the FARAWAVE Nav PFA Catheter Without Pre-Ablation CT vs. Conventional FARAPULSE With Pre-Ablation CT: A Single Centre Randomized Controlled Trial
Led by Cardiocentro Ticino · Updated on 2026-03-19
58
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of two different pulsed field ablation (PFA) catheters for treating atrial fibrillation (AF), a heart rhythm disorder. The first-generation FARAPULSE catheter requires pre-procedural CT imaging to guide the procedure, which adds costs, radiation exposure, and logistical challenges. The second-generation FARAWAVE Nav catheter combines magnetic navigation, detailed mapping, and PFA therapy in one device, potentially improving precision and reducing the need for CT imaging. Participants will be randomly assigned to one of two groups: one using the FARAPULSE catheter with pre-ablation CT imaging, and the other using the FARAWAVE Nav catheter without CT. The FARAWAVE Nav catheter uses advanced mapping software to visualize heart anatomy and electrical activity during the procedure, aiming to isolate the pulmonary veins that contribute to AF. The study will compare fluoroscopy time, radiation exposure, procedural time, costs, number of PFA applications, and AF recurrence between the two groups. During the study, participants will undergo pulmonary vein isolation using the assigned catheter. Researchers will collect data on fluoroscopy time immediately after the procedure and track radiation dose, procedure duration, and AF recurrence for up to six months. The study includes detailed monitoring of heart activity and procedural effectiveness. Total participation includes the procedure and follow-up evaluations to assess outcomes and safety.
CONDITIONS
Brief Title
Comparative Intra-procedural Evaluation of Farapulse and FARAWAVE Nav Catheters
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or older at the time of informed consent
- Signed informed consent obtained
You will not qualify if you...
- Previous left atrial ablation or left atrial surgery
- Presence of intracardiac thrombus
- Persistent atrial fibrillation lasting more than 3 years
- Severe mitral regurgitation or moderate-to-severe mitral stenosis
- Pregnancy (all women under 50 years have a blood test to exclude pregnancy before inclusion)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedural visit
Participants undergo pulmonary vein isolation (PVI) using either the second-generation FARAWAVE Nav catheter without pre-ablation CT or the first-generation FARAPULSE catheter with pre-ablation CT imaging.
1 procedure visit (in-person)
Duration - Up to 6 months
Participants are monitored for atrial fibrillation recurrence and AF burden for up to 6 months after the procedure.
Scheduled follow-up visits over 6 months
Trial Site Locations
Total: 1 location
1
Cardiocentro Ticino - Ente Ospedaliero Cantonale
Lugano, Canton Ticino, Switzerland, 6900
Actively Recruiting
Research Team
M
Marco Bergonti, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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