Comparing FARAPULSE and FARAWAVE Nav catheters during pulmonary vein isolation for atrial fibrillation
Official title: 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
Run by Cardiocentro Ticino · NCT07130773 · Data updated 2026-11-12
This test will see if the FARAWAVE Nav catheter's built-in mapping can be used instead of pre-procedure CT scans for adults having pulmonary vein isolation for atrial fibrillation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 58 (estimated) |
| Sponsor | Cardiocentro Ticino Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Lugano, Canton Ticino) |
| Status | Recruiting |
| Started | November 10, 2025 |
| Main results expected | August 2026 |
| Study ends | December 2026 |
| Registry record updated | March 19, 2026 |
| Trial ID | NCT07130773 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with documented atrial fibrillation who are candidates for catheter ablation and able to give informed consent are eligible, provided they have not had prior left atrial ablation or surgery and have no intracardiac thrombus.
✕Probably not a fit
Patients with previous left atrial ablation or surgery, intracardiac thrombus, long-standing persistent AF (>3 years), significant mitral valve disease, or who are pregnant are unlikely to benefit from or be eligible for this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants undergo pulmonary vein isolation using either the second-generation FARAWAVE Nav catheter without pre-ablation CT or the first-generation FARAPULSE catheter with pre-ablation CT, and procedural mapping and isolation outcomes are compared. The FARAWAVE Nav arm uses integrated magnetic navigation, Field Tag technology, and voltage/activation mapping via the FARAVIEW module to visualize anatomy and energy delivery during the procedure. The FARAPULSE arm uses standard pre-procedural CT (or CMR) to guide ablation with the established first-generation PFA catheter. Procedural accuracy, overlap of applications, mapping quality, and the need for pre-procedural imaging are evaluated intra-procedurally.
Why it matters
Potential benefit: If successful, the FARAWAVE Nav approach could reduce or eliminate the need for pre-procedure CT or CMR, lowering radiation exposure, cost, and logistical burden while maintaining accurate pulmonary vein isolation.
How similar studies have gone: First-generation FARAPULSE PFA has shown good pulmonary vein isolation performance in prior work, but the FARAWAVE Nav system's integrated navigation and mapping features are newer and have limited published outcome data to date.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
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Cardiocentro Ticino - Ente Ospedaliero Cantonale
Lugano, Canton Ticino, Switzerland Recruiting
Study contacts
- Study coordinator: Marco Bergonti, MD PhD
- Email: bergmar21@gmail.com
- Phone: +41 (0) 91 811 51 11
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.