First-in-human experience from RESET-AF (Rapid onE-Shot Electroporation Trial for Atrial Fibrillation)
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Structured PICO
P
Population
36 patients (mean age 57 years, 31% female) with symptomatic paroxysmal and persistent atrial fibrillation followed for 12 months.
I
Intervention
Pulmonary vein isolation using a novel, single-shot pulsed field ablation (PFA) system (ElePulse) guided by 3D mapping, with varying PFA doses (2 to 3 kV) and intravenous hydration protocols across 3 cohorts.
O
Outcome
Co-primary endpoints of freedom from recurrent atrial fibrillation at 12 months > 50% and serious adverse events (SAE) at 7 and 30 days < 5%.
Limitations
- Low numbers
- Short follow-up
- No comparator group
- Not powered to analyze outcome endpoints with statistical significance
- Small population size insufficient to perform statistical significance analyses
- No formal hypothesis testing or power calculation
- Iterative changes to PFA energy and hydration protocols during the study
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“ElePulse provided true single-shot ablations that were fast, effective, and well-tolerated by patients. This study will help us evaluate the system's ability to deliver durable AF treatment without catheter repositioning, greatly contributing to streamlining workflows.”
VRVivek ReddyDirector, Cardiac Electrophysiology, Mount Sinai
“The procedure using the new ElePulse PFA System was efficient. Its single-shot, single-position design performed well and has real potential to simplify AF ablation workflows.”
PNPetr NeužilHead of Cardiology, Na Homolce Hospital
“We are proud to enroll the first patient in the study here at Na Homolce Hospital. As a center committed to research, we are excited to help validate a promising next-generation PFA technology.”
Implication
A novel single-shot pulsed field ablation system demonstrated high rates of durable pulmonary vein isolation and freedom from atrial fibrillation at 12 months with a low complication rate in a first-in-human study.
Abstract
Background and Aims Pulsed field ablation (PFA) is increasingly used to treat patients with atrial fibrillation (AF). The RESET-AF was a single-arm, first-in-human, clinical trial of AF ablation using a novel, single-shot PFA system (ElePulse ® , CRC EP, Tustin, CA, USA), trial registration ACTRN12622001523796 (Date registered 8th December 2022). Methods In 36 consecutively-enrolled patients (57 ± 11 years, 69% male) with symptomatic paroxysmal ( n = 22) and persistent ( n = 14) AF, pulmonary vein isolation (PVI) was performed using this catheter, guided by 3D mapping. All patients underwent remapping at 3 months to confirm PVI durability. Patients were followed at 6 and 12 months with clinical review, Holter monitoring and electrocardiography. The primary efficacy and safety endpoints included a freedom from recurrent AF at 12 months > 50% and serious adverse events (SAE) at 7 and 30 days < 5%, respectively. The secondary efficacy endpoints included 3-month PVI durability > 50% and 6-month freedom from AF > 60%. Results All endpoints were achieved in the entire study cohort. There was 1 SAE (renal impairment which resolved with conservative management) with a total SAE rate of 2.8%. One patient was lost to follow-up at 12 months with a primary efficacy endpoint of 92% (32/35 patients). The secondary efficacy endpoints were 82% 3-month PVI and 94% (34/36 patients) 6-month freedom from AF. During the study, the PFA dose was adjusted in 3 cohorts. The “optimized subset” had 100% PVI durability and freedom from AF at 6 and 12 months without SAEs. Conclusion This study of a novel PFA catheter system for ablation of paroxysmal and persistent AF achieved all predetermined primary and secondary clinical endpoints.
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Cite This Study
Gould et al. (2026) studied Symptomatic paroxysmal and persistent atrial fibrillation (n=36). ElePulse single-shot PFA system was evaluated on Freedom from recurrent AF at 12 months.
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