{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T03:52:12Z","timestamp":1791258732360,"version":"4.1.0"},"reference-count":25,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"2","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Arrhythmia and Electrophysiology"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND:<\/jats:title>\n                    <jats:p>A limitation of ablation for scar-related ventricular tachycardia (VT) is insufficient lesion depth to address nonendocardial substrate. Ultra-low temperature cryoablation (ULTC) at \u2212196\u00b0C has been shown to create transmural lesions in preclinical models. Early human studies in Europe have shown safety and efficacy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS:<\/jats:title>\n                    <jats:p>An EFS (Early Feasibility Study) was designed in collaboration with the Food and Drug Administration as a prospective, nonrandomized evaluation of the acute safety and effectiveness of ULTC ablation for scar-related VT.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS:<\/jats:title>\n                    <jats:p>Twenty patients (age 63\u00b114 years; 5% women; LVEF 36\u00b113%; 45% ischemic and 55% nonischemic) underwent VT ablation with ULTC from September to December 2023 at 4 clinical sites. Ablation strategies included substrate modification during sinus rhythm, as well as activation and entrainment mapping when hemodynamics permitted. Mean ULTC lesions were 9.9\u00b13.6, with a total freeze duration of 47\u00b122 minutes. Noninducibility of the targeted VTs was observed in 13 of 14 patients with inducibility tested both pre- and postablation. There were no procedural strokes, tamponades, or deaths. One suspected cardiac perforation without tamponade was conservatively managed. One patient was excluded from the follow-up efficacy analysis due to RF use, and another lacked postacute follow-up due to death from heart failure 1 month post-procedure. Among surviving per-protocol patients, 23.7\u00b14.3 weeks of freedom from VT and implantable cardioverter defibrillator shock were 61.1% (11\/18) and 83.3% (15\/18), respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS:<\/jats:title>\n                    <jats:p>In a US EFS, ULTC therapy was safe and effective for the treatment of scar-related VT. The EFS design, in collaboration with the Food and Drug Administration, represents an important initiative to accelerate the evaluation of new medical technologies in the United States.<\/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: NCT05675865.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circep.125.014095","type":"journal-article","created":{"date-parts":[[2026,2,2]],"date-time":"2026-02-02T10:00:13Z","timestamp":1770026413000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Ultra-Low Cryoablation for Scar-Related VT Ablation: Results From the US Early Feasibility Study"],"prefix":"10.1161","volume":"19","clinical-trial-number":[{"clinical-trial-number":"nct05675865","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1228-2581","authenticated-orcid":true,"given":"J. Peter","family":"Weiss","sequence":"first","affiliation":[{"name":"University Medical Center Phoenix, The University of Arizona College of Medicine, Phoenix, AZ (J.P.W., R.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5638-4993","authenticated-orcid":true,"given":"Vivek Y.","family":"Reddy","sequence":"additional","affiliation":[{"name":"Icahn School of Medicine, New York, NY (V.Y.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2651-4352","authenticated-orcid":true,"given":"Harikrishna","family":"Tandri","sequence":"additional","affiliation":[{"name":"Vanderbilt University Medical Center, Nashville, TN (H.T., T.D.R., W.G.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9772-0308","authenticated-orcid":true,"given":"Travis D.","family":"Richardson","sequence":"additional","affiliation":[{"name":"Vanderbilt University Medical Center, Nashville, TN (H.T., T.D.R., W.G.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7200-3521","authenticated-orcid":true,"given":"Edward P.","family":"Gerstenfeld","sequence":"additional","affiliation":[{"name":"University of California, San Francisco, CA (E.P.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2118-7893","authenticated-orcid":true,"given":"William G.","family":"Stevenson","sequence":"additional","affiliation":[{"name":"Vanderbilt University Medical Center, Nashville, TN (H.T., T.D.R., W.G.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nabil","family":"Jubran","sequence":"additional","affiliation":[{"name":"Adagio Medical, Inc., Laguna Hills, CA (N.J., I.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-9749-6278","authenticated-orcid":true,"given":"Ilya","family":"Grigorov","sequence":"additional","affiliation":[{"name":"Adagio Medical, Inc., Laguna Hills, CA (N.J., I.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8513-1303","authenticated-orcid":true,"given":"Roderick","family":"Tung","sequence":"additional","affiliation":[{"name":"University Medical Center Phoenix, The University of Arizona College of Medicine, Phoenix, AZ (J.P.W., R.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1161\/circulationaha.113.003063"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2015.05.036"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2409501"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10840-021-00948-6"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2019.12.044"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1093\/europace\/euz247"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacep.2018.11.001"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacep.2019.09.015"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2307291"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCEP.113.000986"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCEP.115.003874"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.19102\/icrm.2018.090202"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/B978-1-4377-1615-3.00009-5"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacep.2025.09.017"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1093\/europace\/euae076"},{"key":"e_1_3_3_17_2","unstructured":"FDA Guidance Document: Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies Including Certain First in Human (FIH) Studies: Guidance for Industry and Food and Drug Administration Staff. 2013. https:\/\/www.fda.gov\/media\/81784\/download Accessed May 1 2025."},{"key":"e_1_3_3_18_2","unstructured":"21st Century Cures Act of 2016. 114th Congress. Public Law 117-255. 130 Stat. 1033. 2016."},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1161\/01.cir.101.11.1288"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCEP.110.959957"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCEP.114.002637"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.119.042423"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2015.11.018"},{"key":"e_1_3_3_24_2","doi-asserted-by":"publisher","DOI":"10.1093\/europace\/euz065"},{"key":"e_1_3_3_25_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.108.788604"},{"key":"e_1_3_3_26_2","unstructured":"LESS-VT trial data FlexAbility Ablation Catheter Sensor Enabled PMA P110016\/S080. https:\/\/www.fda.gov\/medical-devices\/recently-approved-devices\/flexability-ablation-catheter-sensor-enabled-p110016s080 Accessed May 1 2025."}],"container-title":["Circulation: Arrhythmia and Electrophysiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/CIRCEP.125.014095","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,4]],"date-time":"2026-03-04T19:00:29Z","timestamp":1772650829000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCEP.125.014095"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2]]},"references-count":25,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2026,2]]}},"alternative-id":["10.1161\/CIRCEP.125.014095"],"URL":"https:\/\/doi.org\/10.1161\/circep.125.014095","relation":{},"ISSN":["1941-3149","1941-3084"],"issn-type":[{"value":"1941-3149","type":"print"},{"value":"1941-3084","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2]]},"assertion":[{"value":"2025-05-20","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-01-13","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-02-02","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}