Comparing FARAPULSE and FARAWAVE Nav catheters during pulmonary vein isolation for atrial fibrillation
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cardiocentro Ticino Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Lugano, Canton Ticino) |
| Trial ID | NCT07130773 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lugano, Canton Ticino
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.