US-based firm CardioFocus has initiated three clinical trials to investigate the use of its HeartLight Endoscopic Ablation System for the treatment of atrial fibrillation (AF).
The system is a catheter ablation technology that features direct visualisation, titratable laser energy and universal balloon design.
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The first prospective, multi-centre, randomised CardioFocus vs contact force-guided pulmonary vein isolation in paroxysmal atrial fibrillation (CF²) trial will evaluate the acute procedure, safety and long-term clinical outcomes of the system in 350 paroxysmal AF patients at up to ten European sites.
The trial will compare the system with the contact-force sensing irrigated radiofrequency (RF) ablation catheter, with or without the combination of 3D electroanatomical mapping (EAM).
Designed to enrol 200 persistent AF and 200 paroxysmal AF patients across Europe, the second randomised trial will compare the HeartLight System with Cryoballoon.
A previous study conducted to compare the system and Cryoballoon is reported to have demonstrated a 73% success rate with the HeartLight System at 12 months in paroxysmal AF patients, when compared to 63% with the Cryoballoon.
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By GlobalDataCardioFocus executive chairman Paul LaViolette said: “We are greatly encouraged by all the positive data collected to date on the HeartLight System, and look forward to the results of these new exciting studies."
The third clinical trial will involve treatment of approximately 250 patients during commercial use of the HeartLight System at 25 US centres.
This trial aims to validate the results of a completed pivotal study in the country as well as research additional queries.
