CardioFocus today announced the launch of 3 studies of its HeartLight endoscopic ablation system, touting that over 1,000 patients with atrial fibrillation will be enrolled across the studies.
The Marlborough, Mass.-based company’s HeartLight system is designed to allow electrophysiologists to control the delivery of laser energy through direct visual guidance to isolate pulmonary veins with a high procedural flexibility. The device includes a compliant balloon to accommodate diverse PV anatomies and has a short learning curve to allow for quick adoption of the tech, the company said.
In the 1st study, researchers will compare the acute procedure and safety outcomes along with long-term clinical 2 groups of patients being treated for paroxysmal AF, the company said. The 1st group will be treated with the HeartLight system, while the other will be treated with a commercially available contact force sensing irrigated radiofrequency ablation catheter and possible 3D electroanatomical mapping. The study is slated to enroll 350 patients at approximately 10 centers across Europe.
The 2nd study looks to enroll 400 patients, 4 separate arms. The trial aims to enroll 200 patients with paroxysmal AF and 200 with persistent AF, of which 100 of each will be treated with the HeartLight system and 100 will be treated with a cryoballoon.
In its 3rd study, the company will evaluate clinical outcomes in a cohort of patients treated during commercial use of the HeartLight system, looking to verify results from the company’s successful US clinical pivotal study. The trial aims to enroll 250 patients at 25 sites in the US.
CardioFocus said the 3 studies would help provide additional clinical evidence of the performance of its HeartLight system in patients with AF.
“The data continue to reinforce the chronic efficacy of laser balloon ablation with the HeartLight System in our most recent single center comparative analysis showing freedom from AF at one year of 93 percent,” Dr. Pieter Koopman said in a prepared statement.
“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 enrolling up to 1,000 AF patients. Our goal is to be a leader in the field of pulmonary vein isolation, which includes supporting the initiation of clinical studies that provide further evidence of the HeartLight System’s impressive safety and efficacy profile and make this technology more widely accessible to the more than 9 million1 patients, in the U.S. and Europe, who are suffering from AF,” exec chair Paul LaViolette said in a press release.
In March, CardioFocus raised $20.2 million in a round of equity and options financing, according to an SEC filing posted this week.
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