OBJECTIVES: To evaluate the safety and acute performance of a novel catheter for very high power–short duration (vHPSD) ablation in the treatment of paroxysmal atrial fibrillation (PAF).
BACKGROUND: The vHPSD catheter is a novel contact force–sensing catheter optimized for temperature-controlled radiofrequency ablation with microelectrodes and 6 thermocouples for real-time temperature monitoring; the associated vHPSD algorithm modulates power to maintain target temperature during 90W/4s lesions.
METHODS: QDOT-FAST is a prospective, multicenter, single-arm study enrolling patients with symptomatic PAF indicated for catheter-based pulmonary vein isolation (PVI). Primary endpoints were acute effectiveness (confirmation of entrance block in all targeted pulmonary veins [PVs] after adenosine/isoproterenol challenge) and acute safety (primary adverse events [PAEs]). Participants were screened for silent cerebral lesions (SCLs) by MRI. Patients were followed for 3 months post-ablation.
RESULTS: A total of 52 patients underwent ablation and completed follow-up. PVI was achieved in all patients using the study catheter alone, with total procedure and fluoroscopy times of 105.2 ± 24.7 and 6.6 ± 8.2 minutes, respectively. Most patients (n=49; 94.2%) were in sinus rhythm at 3 months. Two PAEs were reported: one pseudoaneurysm and one asymptomatic thromboembolism. There were no deaths, stroke, atrioesophageal fistula, PV stenosis, or unanticipated adverse device effects. Six patients had identified SCLs—all classified as asymptomatic without clinical or neurologic deficits.
CONCLUSIONS: This first-in-human study of a novel catheter with optimized temperature control demonstrated the clinical feasibility and safety of vHPSD ablation. Procedure and fluoroscopy times were substantially lower than historical standard ablation with point-by-point catheters.