Key result
The nsPFA CellFX Clamp System produced mature scar formation with no serious adverse events, compared to a 7.1% rate of incomplete scar maturation and 1 mortality with radiofrequency ablation.
Why the study?
The study was designed to demonstrate the safety and efficacy of a new nanosecond pulsed-field ablation (nsPFA) parallel clamp in ablating different cardiac tissue.
Does a nanosecond pulsed-field ablation surgical clamp improve the safety and efficacy of cardiac tissue ablation compared to bipolar radiofrequency ablation in a chronic porcine model?
Does a nanosecond pulsed-field ablation surgical clamp improve the safety and efficacy of cardiac tissue ablation compared to bipolar radiofrequency ablation in a chronic porcine model?
In a preclinical porcine model, a novel nanosecond pulsed-field ablation surgical clamp demonstrated a promising safety profile and reliable transmural ablation compared to standard bipolar radiofrequency ablation.
Supports progression to human trials of nsPFA clamp; leaves open clinical safety and efficacy.
OBJECTIVE: The purpose of this chronic porcine model is to demonstrate the safety and efficacy of a new nanosecond pulsed-field ablation (nsPFA) parallel clamp in ablating different cardiac tissue. METHODS: The Pulse Biosciences nsPFA CellFX Clamp System was tested on 6 pigs. Ablations were performed in all 4 heart chambers by delivering a sequence of very short-duration, high-amplitude electrical pulses taking 1.25 seconds per application independent of tissue thickness or type. Testing for electrical exit block was performed at the time of surgery and at study termination. At 35 days, animals were killed humanely and anonymized histopathology was performed to assess lesion width, depth, and transmurality. Lesion pattern and general safety were compared with 6 animals in which a bipolar radiofrequency clamp was used (AtriCure Synergy Isolator System). RESULTS: There were no device-related serious adverse events in the nsPFA group. There was 1 early device-related mortality at day 24 in the RFA group from perforation of 1 of the ventricular ablation sites. There were also 2 intracardiac thrombotic events with 1 systemic thromboembolic event in the radiofrequency group. Exit block was confirmed in all animals from both groups for the pulmonary veins and the posterior wall. Histologic findings were consistent and demonstrated mature scar formation in all nsPFA ablation specimens, whereas a 7.1% rate of incomplete histopathological scar maturation was present in the RFA group. CONCLUSIONS: In this chronic porcine model, a single 1.25-second application independent of tissue thickness with the CellFX Parallel Clamp System demonstrated promising safety and efficacy profile. All lesions produced by this technology resulted in persistent exit block around pulmonary veins and the posterior atrial wall consistent with a reliable, contiguous and transmural ablation without injury to adjacent organs.
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Dunnington et al. (2024) studied Cardiac tissue ablation (n=12). Pulse Biosciences nsPFA CellFX Clamp System vs. Bipolar radiofrequency clamp (AtriCure Synergy Isolator System) was evaluated on Incomplete histopathological scar maturation. The nsPFA CellFX Clamp System produced mature scar formation with no serious adverse events, compared to a 7.1% rate of incomplete scar maturation and 1 mortality with radiofrequency ablation.
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