Thermedical has treated the first patient in a pivotal clinical trial of its saline-enhanced radiofrequency (SERF) ablation system, used in conjunction with the Durablate catheter, for ventricular tachycardia (VT) that persists despite medication and multiple previous ablation attempts.
The procedure took place at the Montreal Heart Institute, Canada, and was performed by Université de Montréal associate professor and cardiac electrophysiologist Dr Katia Dyrda.
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According to Thermedical, the patient had previously undergone four ablation procedures but continued to experience quick and dangerous VT episodes.
These arrhythmias were attributed to non-ischemic cardiomyopathy resulting from myocarditis, a condition where inflammation, rather than blocked arteries, weakens the heart muscles.
Often caused by viral infections, the inflammation can result in scar tissue that increases the risk of dangerous heart rhythms.
For individuals with this form of VT, treatment often includes the implantation of a cardioverter defibrillator (ICD). While ICDs can prevent sudden cardiac death, the shocks they deliver may be distressing for patients, particularly those who receive them frequently.
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By GlobalDataDuring the recent procedure, the SERF ablation technique allowed Dr Dyrda to target myocardial tissue deep within the heart muscle, resulting in the elimination of all inducible VT.
The study is said to build upon previous feasibility research, which indicated promising results such as the clinical VT elimination during the procedure and a decrease in ICD shocks during subsequent follow-up.
The SERF ablation system employs a saline-enhanced energy delivery approach, intended to achieve deeper heating of problematic heart tissue.
The Durablate catheter is aimed at delivering this energy to address intramural VT sources that may lead to repeated interventions, shocks, and ongoing clinical instability.
SERF ablation inventor and Thermedical CEO and co-founder Dr Michael Curley said: “Initiating this pivotal study is a significant step forward for Thermedical and reflects the strong progress our team has made in developing a differentiated VT therapy.
“The transition from feasibility work into a pivotal trial is a major milestone for any company, and we are committed to executing this study with the rigour required for a premarket approval submission.”
