Advanced Cardiac Therapeutics has enrolled the first patient in a first-in-man CE mark clinical trial to evaluate the safety and performance of the company's Tempasure cardiac ablation catheter.
The Tempasure system is the RF cardiac ablation catheter to offer both saline irrigation and temperature-sensing technology.
The system features a passive sensing microwave radiometry technology, which allows the electrophysiologist to measure the temperature of the cardiac tissue at 3mm depth during the ablation procedure.
The information can provide real-time information, facilitating proper energy delivery and lesion control.
The prospective, multi-centre, single arm study will enroll up to 30 patients with atrial flutter in Europe and New Zealand.
The patient enrolled in the trial will be analyzed during ablation, while the follow-up will be conducted at 7 and 30 days.