{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,11]],"date-time":"2026-07-11T11:58:57Z","timestamp":1783771137465,"version":"3.55.0"},"reference-count":5,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T00:00:00Z","timestamp":1774569600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T00:00:00Z","timestamp":1774569600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100015135","name":"Haemonetics Corporation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015135","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cardiovasc electrophysiol"],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>With catheter\u2010based interventions increasingly requiring large\u2010bore venous access, reliable closure methods for 16\u201017F sheaths are essential. Current manual compression techniques can prolong recovery, delay ambulation and discharge candidacy, and cause patient discomfort. The VASCADE MVP XL Venous Vascular Closure System is designed to address this gap.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>The AMBULATE EXPAND trial was a prospective, single\u2010arm, multi\u2010center pivotal study designed to evaluate the safety and efficacy of the investigational device for closure of large\u2010bore femoral venous access sites, and to generate evidence for customary regulatory review.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This trial (February\u2013September of 2025) enrolled patients undergoing non\u2010emergent procedures requiring a single 16\u201017F outer diameter (OD) sheath and optional smaller sheaths. The primary efficacy endpoint was time to ambulation. The primary safety endpoint was the 30\u2010day rate of major access\u2010site complications. Secondary endpoints included time to hemostasis, total post\u2010procedure time, discharge eligibility, device success, and 30\u2010day rate of minor access\u2010site complications.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 77 patients were enrolled with none lost to follow\u2010up. The study met both primary efficacy and safety endpoints. The mean time to ambulation was 3.2\u2009h, and mean time to hemostasis was 2.7\u2009min. The mean total post\u2010procedure and time to discharge eligibility were 3.3 and 3.4\u2009h, respectively. Device success was achieved in 98.7% of access sites. The primary safety endpoint of major venous access site closure\u2010related complications over 30 days was 0%. Minor venous access site closure\u2010related complications were also 0%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The study results demonstrate that the VASCADE MVP XL device provides safe and effective percutaneous closure of femoral venous access sites after catheter\u2010based procedures using 16\u201017F OD sheaths. Compared to standard performance goals from manual compression, the VASCADE MVP XL significantly reduced time to ambulation, hemostasis, discharge eligibility, and overall post\u2010procedure time.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/jce.70324","type":"journal-article","created":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T07:31:03Z","timestamp":1774596663000},"page":"989-994","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Safety and Efficacy of the VASCADE MVP\u00ae XL Venous Vascular Closure System for Management of Femoral Venotomy Following Catheter\u2010Based Interventions Utilizing 16\u201017F OD Sheaths: The AMBULATE EXPAND Trial"],"prefix":"10.1111","volume":"37","author":[{"given":"Hugh Thomas","family":"McElderry","sequence":"first","affiliation":[{"name":"Department of Medicine University of Alabama at Birmingham Birmingham Alabama USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amin","family":"Al\u2010Ahmad","sequence":"additional","affiliation":[{"name":"Texas Cardiac Arrhythmia Institute, St. David's Medical Center Austin Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David De","family":"Lurgio","sequence":"additional","affiliation":[{"name":"Emory Healthcare Atlanta Georgia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5349-0136","authenticated-orcid":false,"given":"T.","family":"Jared Bunch","sequence":"additional","affiliation":[{"name":"University of Utah Hospital Salt Lake City Utah USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1872-662X","authenticated-orcid":false,"given":"Zayd A.","family":"Eldadah","sequence":"additional","affiliation":[{"name":"Heart &amp; Vascular Institute, MedStar Health Columbia Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maheer","family":"Gandhavadi","sequence":"additional","affiliation":[{"name":"Overlake Medical Center Bellevue Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce","family":"Hook","sequence":"additional","affiliation":[{"name":"Department of Cardiology Lahey Hospital &amp; Medical Center Burlington Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Banno","sequence":"additional","affiliation":[{"name":"Department of Medicine University of Alabama at Birmingham Birmingham Alabama USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suneet","family":"Mittal","sequence":"additional","affiliation":[{"name":"Electrophysiology, Valley Health System Paramus New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,3,27]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacep.2019.08.013"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/jce.15763"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.30229"},{"issue":"1","key":"e_1_2_13_5_1","first-page":"A62","article-title":"Vascular Access Site Closure With the New VASCADE\u2010XL Versus the Earlier VASCADE\u2010MVP in Patients Undergoing Electrophysiology Procedures: A Single\u2010Center Experience on Efficacy and Complications","volume":"56","author":"Natale","year":"2025","journal-title":"Journal of Cardiovascular Electrophysiology"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2023.09.105"}],"container-title":["Journal of Cardiovascular Electrophysiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jce.70324","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/jce.70324","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jce.70324","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T11:26:33Z","timestamp":1779103593000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jce.70324"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,27]]},"references-count":5,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,5]]}},"alternative-id":["10.1111\/jce.70324"],"URL":"https:\/\/doi.org\/10.1111\/jce.70324","archive":["Portico"],"relation":{},"ISSN":["1045-3873","1540-8167"],"issn-type":[{"value":"1045-3873","type":"print"},{"value":"1540-8167","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,27]]},"assertion":[{"value":"2025-11-19","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-16","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-27","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}