Atrial Fibrillation Clinical Trial
Official title:
Focal Impulse and Rotor Modulation (FIRM) as a Stand-alone Procedure in the Treatment of Atrial Fibrillation
The FIRM Study Oslo will in two sequential within-patient trials investigate the efficacy of focal impulse and rotor modulation (FIRM) as a stand-alone procedure in the treatment of paroxysmal and persistent atrial fibrillation, evaluated by continuous pre- and post-procedural heart rhythm monitoring.
After a pilot/implementation study consisting of 10 patients with paroxysmal atrial
fibrillation (AF); 20 patients with paroxysmal AF will be included in a within-patient
trial. This study will be followed by a similar comparison in 20 patients with persistent or
longstanding persistent AF.
The AF driving sources will be visualized by a novel sequential bi-atrial panoramic contact
mapping technique. Unipolar signals will be recorded by a 64-polar basket catheter (FIRMap®,
Topera. Inc.), then processed and the activation patterns visualized (RhythmView® 3D
Electrophysiologic Mapping System, Topera, Inc.).
Focal impulse and rotor modulation (FIRM) will then be performed with standard irrigated
radio frequency catheter ablation until rotor or focal impulse elimination is confirmed by
repeat FIRM mapping.
Treatment efficacy will be assessed with continuous heart rhythm monitors (Reveal XT®,
Medtronic, Minneapolis, USA) implanted 3 months prior to ablation, and freedom from AF
defined as AF burden <1% at follow-up at 12, 24 and 30 months.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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