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Comparative Intra-procedural Evaluation of Farapulse and FARAWAVE Nav Catheters

RecruitingNAAges 18 Years - anyAllCardiocentro Ticino
NCT07130773 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 f

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📋 Eligibility rules (as published)
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).
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What it tests

  • Second-generation FARAWAVE Nav catheter without the use of pre-ablation CT
  • FARAPULSE with pre-ablation CT
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Where

1 site
Cardiocentro Ticino - Ente Ospedaliero Cantonale
Lugano, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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