EICHORCondition: Atrial Fibrillation (AF) · Pulsed-field Ablation · Sponsor: Semmelweis University
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Objective: To evaluate the feasibility, acute, and three-month efficacy and safety of near-zero fluoroscopy PVI performed with the Farapulse system (Faravawe catheter, Faradrive sheath, Faraview module). Primary hypothesis: High durability of PVI is achievable with minimal fluoroscopy PVI, using ICE-guided transseptal puncture and Farapulse system. Study Design: Single-center, prospective, single-arm study. Investigator-initiated study. Research period, expected enrollment rate: The planned research period starts in the third quarter of 2024. The expected enrollment rate is 4 patients/week. The enrollment and performance of the index procedure are expected to be completed within 1.5 - 2 months, and then three more months are required before the remap procedure. Procedure: Standard PVI using Farapulse system and Faraview module. Follow-up: Invasive left atrial remap 3 months after the procedure. Imaging: CT and MRi scans to detect pulsed-field ablation scars before the FU procedure. Endpoints: * Primary endpoint: PVI durability at three months, detected by invasive left atrial remap, on a per PV basis. * Secondary endpoints: * Continuity and size of the scar caused by the index ablation, detected on the cardiac MRI and CT before the remap (to compare it with the remapping data) * Door-to-door time (total time spent in the EP lab) * Skin-to-skin procedure time: time from the first femoral vein puncture to the removal of all sheaths * Left atrial dwelling time: ti…
This description comes directly from the study's public registry record.
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Inclusion Criteria: * Symptomatic paroxysmal AF * Age \>18 years * Willingness to sign the informed consent form Exclusion Criteria: * Contraindication to ablation * Contraindication of long-term anticoagulation * Persistent AF * History of typical or atypical flutter * History of PVI * History of cardiac surgery * Contraindication of cardiac MRi examination * Pregnancy * Active malignancy * Life expectancy \<1 year * Valvular AF * Reversible cause of AF (e.g. hyperthyroidism).
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| Semmelweis University | Budapest, Pest County, Hungary | — |
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Source record: clinicaltrials.gov/study/NCT07752771