First-in-human experience from RESET-AF (Rapid onE-Shot Electroporation Trial for Atrial Fibrillation)

{"BACKGROUND":[0],"AND":[1],"AIMS:":[2],",":[3],"CRC":[4],"EP,":[5],"Tustin,":[6],"CA,":[7],"USA),":[8],"trial":[9],"registration":[10],"ACTRN12622001523796":[11],"(Date":[12],"registered":[13],"8th":[14],"December":[15],"2022).":[16],"METHODS:":[17],"In":[18],"36":[19],"consecutively-enrolled":[20],"patients":[21,54],"(57":[22],"±":[23],"11":[24],"years,":[25],"69%":[26],"male)":[27],"with":[28,72,144,147,163],"symptomatic":[29],"paroxysmal":[30,229],"(n":[31,36],"=":[32,37],"22)":[33],"and":[34,69,77,82,96,103,119,180,206,212,230,237],"persistent":[35,231],"14)":[38],"AF,":[39],"pulmonary":[40],"vein":[41],"isolation":[42],"(PVI)":[43],"was":[44,137,156,194],"performed":[45],"using":[46],"this":[47],"catheter,":[48],"guided":[49],"by":[50],"3D":[51],"mapping.":[52],"All":[53,127],"underwent":[55],"remapping":[56],"at":[57,67,91,101,160,210],"3":[58,197],"months":[59,71,93,162,214],"to":[60,158],"confirm":[61],"PVI":[62,115,179,204],"durability.":[63],"Patients":[64],"were":[65,129,176],"followed":[66],"6":[68,211],"12":[70,92,161,213],"clinical":[73,239],"review,":[74],"Holter":[75],"monitoring":[76],"electrocardiography.":[78],"The":[79,109,172,199],"primary":[80,165,236],"efficacy":[81,111,166,174],"safety":[83],"endpoints":[84,112,128,175],"included":[85,113],"a":[86,148,164,221],"freedom":[87,121,185,207],"from":[88,122,186,208],"recurrent":[89],"AF":[90,123,209,232],">":[94,117,124],"50%":[95,118],"serious":[97],"adverse":[98],"events":[99],"(SAE)":[100],"7":[102],"30":[104],"days":[105],"<":[106],"5%,":[107],"respectively.":[108],"secondary":[110,173,238],"3-month":[114,178],"durability":[116,205],"6-month":[120,184],"60%.":[125],"RESULTS:":[126],"achieved":[130,233],"in":[131,196],"the":[132,189,191],"entire":[133],"study":[134,219],"cohort.":[135],"There":[136],"1":[138],"SAE":[139,150],"(renal":[140],"impairment":[141],"which":[142],"resolved":[143],"conservative":[145],"management)":[146],"total":[149],"rate":[151],"of":[152,168,220,228],"2.8%.":[153],"One":[154],"patient":[155],"lost":[157],"follow-up":[159],"endpoint":[167],"92%":[169],"(32/35":[170],"patients).":[171],"82%":[177],"94%":[181],"(34/36":[182],"patients)":[183],"AF.":[187],"During":[188],"study,":[190],"PFA":[192,223],"dose":[193],"adjusted":[195],"cohorts.":[198],"\\"optimized":[200],"subset\\"":[201],"had":[202],"100%":[203],"without":[215],"SAEs.":[216],"CONCLUSION:":[217],"This":[218],"novel":[222],"catheter":[224],"system":[225],"for":[226],"ablation":[227],"all":[234],"predetermined":[235],"endpoints.":[240]}

Authors

Institutions

Publication Details

Journal
Journal of Interventional Cardiac Electrophysiology
Published
2026-09-17
DOI
https://doi.org/10.1007/s10840-026-02434-3
Primary Topic
Atrial Fibrillation Management and Outcomes
Type
article
Field-Weighted Citation Impact
0.00

Funders

Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
article

First-in-human experience from RESET-AF (Rapid onE-Shot Electroporation Trial for Atrial Fibrillation)

Arash Aryana, Paul A. Gould, Pierre C. Qian, Stuart P. Thomas et al.
Journal of Interventional Cardiac Electrophysiology
Atrial Fibrillation Management and Outcomes
article

First-in-human experience from RESET-AF (Rapid onE-Shot Electroporation Trial for Atrial Fibrillation)

Arash Aryana, Paul A. Gould, Pierre C. Qian, Stuart P. Thomas, Waheed Ahmad
article en

Abstract

BACKGROUND AND AIMS: , 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.

Journal of Interventional Cardiac Electrophysiology
Mercy General Hospital (US), Princess Alexandra Hospital (AU), Dignity Health (US), Westmead Hospital (AU), Princess Alexandra Hospital (GB)
National Health and Medical Research Council
Peace, Justice and strong institutions
Openalex Percentile: Top 11%
Atrial Fibrillation Management and Outcomes
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.