Non-paroxysmal Atrial Fibrillation Clinical Trial
Official title:
EnSite™ HD Grid Catheter Mapping System for Advanced High Density Three-Dimensional Mapping in Non-Paroxysmal Atrial Fibrillation and Atrial Tachycardia
In this clinical investigation, the safety, feasibility and performance of the novel EnSite™ HD Grid Catheter mapping system for advanced high-density three-dimensional mapping will be studied in patients undergoing catheter ablation procedures for the treatment of non-paroxysmal atrial fibrillation (AF) or left atrial tachycardia (AT).
Catheter ablation for non-paroxysmal AF is more complex as triggers, if present at all, are
not immediately apparent, but the abnormal atrial substrates are the likely predominant
mechanisms. Additional catheter ablation strategies targeting for atrial substrate
modification have been introduced. The common strategies involve either application of
empirical linear lesion sets in the atrial areas or ablation of atrial areas with complex
fractionated atrial electrograms in addition to pulmonary vein isolation. Nevertheless, the
corresponding success rates in long-term sinus rhythm maintenance are modest.
Non-paroxysmal AF and left AT are characterized by fast and regular atrial activities,
complex fractionated atrial electrograms, consistent direction of wave front propagation, and
low peak-to-peak voltage. Advanced high-density three-dimensional catheter mapping strategies
to target the evaluation of these characteristics and mechanisms responsible for the AF and
left AT, identification of atrial areas with low peak-to-peak voltages and determination of
the "critical" atrial targets for catheter ablation during the procedures would be essential.
In this clinical investigation, the safety, feasibility and performance of the novel EnSite™
HD Grid Catheter mapping system for advanced high-density three-dimensional mapping will be
studied in patients undergoing catheter ablation procedures for the treatment of
non-paroxysmal AF or left AT.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06021808 -
LAA Clipping Versus NOACs to Prevent Stroke in Non-paroxysmal Atrial Fibrillation.
|
N/A |