ArticleJournal of cardiovascular electrophysiology2026
Real-World Adverse Events Associated With the Sphere-9 Dual-Energy Arrhythmia Ablation Catheter.
Article in Journal of cardiovascular electrophysiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Who cites it
1 citing paper in PubMed.
- Intraprocedural Fibrin Clot Formation During Pulmonary Vein Isolation With a Lattice-Tip Ablation Catheter.Journal of cardiovascular electrophysiology · 2026Article
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionSphere-9 is a lattice tip ablation catheter (Medtronic, USA) capable of delivering both pulsed field and radiofrequency ablation. It is approved for the treatment of atrial fibrillation. Adverse events related to this device have been reported to national databases. A systematic assessment of these reports is needed to understand the nature of device-related complications.
methodsWe queried the FDA Manufacturer and User Facility Device Experience (MAUDE) database between October 24, 2024 and October 24, 2025 to identify reports related to the Sphere-9 catheter. A total of 222 reports were included in the final analysis.
resultsOf 222 reports, 148 (67%) resulted in clinical events. Of these, 107 were suspected to be related to the Sphere-9, including: VT/VF during/following energy delivery (n = 30), Stroke/TIA (n = 25), sinus node dysfunction/AV block (n = 23), pericardial effusion (n = 7), coronary spasm (n = 9), and phrenic nerve injury (n = 2). Catheter/defibrillator (ICD) related interactions were suspected in 10 of the VT/VF reports. There were 65 catheter related reports that did not appear to be associated with adverse clinical events, which included tissue/char formation on the catheter tip (n = 24), steam pop (n = 25), and mechanical entrapment (n = 7).
conclusionThis early analysis of adverse events reported for the Sphere-9 catheter highlights complications including arrhythmias, such as VT/VF and AV block, and the risks associated with ICD-catheter related interactions.
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