{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T05:55:03Z","timestamp":1790402103065,"version":"4.1.0"},"reference-count":31,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"3","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Arrhythmia and Electrophysiology"],"published-print":{"date-parts":[[2020,3]]},"abstract":"<jats:sec>\n            <jats:title>Background:<\/jats:title>\n            <jats:p>Catheter ablation for atrial fibrillation (AF) using point-by-point radiofrequency energy or single-application one-shot balloons is either technically challenging or have limited ability to accommodate variable patient anatomy to achieve acute and durable pulmonary vein (PV) isolation. A novel ablation system employs low intensity collimated ultrasound (LICU)-guided anatomic mapping and robotic ablation to isolate PVs. In this first-in-human, single-center, multioperator trial, VALUE trial (VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation; NCT03639597) in patients with paroxysmal atrial fibrillation, this LICU system was evaluated to determine its safety, effectiveness in PV isolation, and freedom from recurrent atrial arrhythmias.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods:<\/jats:title>\n            <jats:p>In the enrolled 52 patients with paroxysmal atrial fibrillation, ultrasound M-mode\u2013based left atrial anatomies were successfully created, and ablation was performed under robotic control along an operator-defined lesion path. The LICU system software advanced over the course of the study: the last 13 patients were ablated with enhanced software.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results:<\/jats:title>\n            <jats:p>Acute PV isolation was achieved in 98% of PVs\u2014using LICU-only in 77.3% (153\/198) of PVs and requiring touch-up with a standard radiofrequency ablation catheter in 22.7% (45\/198) PVs. The touch-up rate decreased to 5.8% (3\/52) in patients undergoing LICU-ablation with enhanced software. Freedom from atrial arrhythmia recurrence was 79.6% (39\/49 patients) at 12 months or 92.3% (12\/13 patients) with the enhanced software. Major adverse events occurred in 3 patients (5.8%): one had transient diaphragmatic paralysis, one vascular access complication, and one had transient ST-segment elevation from air-embolism, without sequelae.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions:<\/jats:title>\n            <jats:p>In this first-in-human study, low- intensity collimated ultrasound-guided anatomic mapping and robotic ablation allows PV isolation with good chronic safety; PV isolation success is improving with device enhancements.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Registration:<\/jats:title>\n            <jats:p>\n              URL:\n              <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n              ; Unique identifier: NCT03639597.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/circep.119.007917","type":"journal-article","created":{"date-parts":[[2020,2,13]],"date-time":"2020-02-13T04:32:03Z","timestamp":1581568323000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["Automated Noncontact Ultrasound Imaging and Ablation System for the Treatment of Atrial Fibrillation"],"prefix":"10.1161","volume":"13","author":[{"given":"Mohit K.","family":"Turagam","sequence":"first","affiliation":[{"name":"Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, NY (M.K.T., W.W., S.R.D., V.Y.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Petru","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Homolka Hospital, Prague, Czech Republic (J.P., P.N., K.K., S.K., V.Y.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petr","family":"Neuzil","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Homolka Hospital, Prague, Czech Republic (J.P., P.N., K.K., S.K., V.Y.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ken","family":"Kakita","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Homolka Hospital, Prague, Czech Republic (J.P., P.N., K.K., S.K., V.Y.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stepan","family":"Kralovec","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Homolka Hospital, Prague, Czech Republic (J.P., P.N., K.K., S.K., V.Y.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Harari","sequence":"additional","affiliation":[{"name":"VytronUS, Inc, Sunnyvale, CA (D.H., P.P., D.P.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Phillips","sequence":"additional","affiliation":[{"name":"VytronUS, Inc, Sunnyvale, CA (D.H., P.P., D.P.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danielo","family":"Piazza","sequence":"additional","affiliation":[{"name":"VytronUS, Inc, Sunnyvale, CA (D.H., P.P., D.P.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Whang","sequence":"additional","affiliation":[{"name":"Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, NY (M.K.T., W.W., S.R.D., V.Y.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Srinivas R.","family":"Dukkipati","sequence":"additional","affiliation":[{"name":"Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, NY (M.K.T., W.W., S.R.D., V.Y.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5638-4993","authenticated-orcid":false,"given":"Vivek Y.","family":"Reddy","sequence":"additional","affiliation":[{"name":"Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, NY (M.K.T., W.W., S.R.D., V.Y.R.)."},{"name":"Department of Cardiology, Homolka Hospital, Prague, Czech Republic (J.P., P.N., K.K., S.K., 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