Why the study?
The study was conducted to evaluate the safety and efficacy of a PFA dosage range in preparation for a clinical trial and to characterize its non-thermal nature.
Does pulsed field ablation safely and effectively create chronic lesions in a porcine model?
Does pulsed field ablation safely and effectively create chronic lesions in a porcine model?
Pulsed field ablation safely creates complete circumferential replacement fibrosis in a preclinical porcine model, supporting its evaluation in clinical trials.
Supports advancement to human PFA trials; leaves open translation of durability and safety to patients.
PFA deliveries to the SVC, RAA, and RSPV resulted in complete circumferential replacement fibrosis at 4-week postablation with an excellent chronic myocardial and collateral tissue safety profile. This GLP study evaluated the safety and efficacy of a dosage range in preparation for a clinical trial and characterized the non-thermal nature of PFA.
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Stewart et al. (2021) studied this question.
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