The prospective, randomised, multi-centre, investigational device exemption (IDE) clinical trial is designed to evaluate the effectiveness and safety of the TactiCath1 force-sensing ablation catheter for the treatment of symptomatic paroxysmal AF.
The study will be conducted at 30 centres across the US and Europe, and will enrol 300 patients who will be randomised to be treated with either Endosense’s force-sensing TactiCath or a catheter approved by the FDA for paroxysmal AF.
The study’s primary endpoint will evaluate procedural success as well as chronic freedom from symptomatic AF, atrial tachycardia and atrial flutter at 12 months.
The safety endpoint will be incidence of device-related serious adverse events.
In addition, the study will also assess the role of real-time contact force information to procedural effectiveness during ablation compared to conventional radiofrequency (RF) irrigated catheters.
The results of the study will be used to support a Premarket Approval Application (PMA) to the US Food and Drug Administration (FDA) for approval of the TactiCath catheter and accompanying TactiSys system.
