{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T03:59:09Z","timestamp":1793073549013,"version":"4.5.0"},"reference-count":16,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"4","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Arrhythmia and Electrophysiology"],"published-print":{"date-parts":[[2025,4]]},"abstract":"<jats:sec>\n            <jats:title>BACKGROUND:<\/jats:title>\n            <jats:p>A dual-chamber leadless pacemaker can provide bradycardia therapy to most patients with pacemaker indications without the complications associated with a lead or pulse generator. We sought to confirm whether previously reported 3-month safety and performance outcomes were sustained through 12 months by determining whether 12-month complication-free and performance success rates exceeded their prespecified performance goals.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>METHODS:<\/jats:title>\n            <jats:p>Patients were enrolled in the prospective, single-group Aveir DR i2i Study if they had a standard indication for dual-chamber pacing. Enrolled patients were implanted with an Aveir DR dual-chamber leadless pacemaker system, which comprised 2 communicating leadless pacemakers (1 in the right atrium and 1 in the right ventricle). The primary safety outcome evaluated whether freedom from serious device- or procedure-related events through 365 days exceeded the predetermined performance goal of 76.5%. The primary performance outcome determined whether the composite of atrial capture threshold (\u22643.0 V at 0.4 ms) and sensing amplitude (P-wave \u22651.0 mV) at the 12-month visit exceeded the predetermined performance goal of 80.0%.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS:<\/jats:title>\n            <jats:p>\n              Sites attempted implantation in 300 subjects, where 63.3% had sinus-node dysfunction and 33.3% had atrioventricular block as their primary pacing indication. The primary safety end point was achieved, with a Kaplan-Meier 12-month complication-free rate of 88.6% (95% CI, 84.5\u201391.8;\n              <jats:italic>P<\/jats:italic>\n              &lt;0.001). The primary performance end point was achieved in 92.8% of patients (95% CI, 89.7\u201395.8;\n              <jats:italic>P<\/jats:italic>\n              &lt;0.001).\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSIONS:<\/jats:title>\n            <jats:p>Both primary safety and performance end points were met after 1 year, demonstrating consistency with previously reported 3-month outcomes of a dual-chamber leadless pacemaker.<\/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: NCT05252702.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/circep.124.013619","type":"journal-article","created":{"date-parts":[[2025,3,27]],"date-time":"2025-03-27T09:01:50Z","timestamp":1743066110000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":16,"title":["One-Year Safety and Performance of a Dual-Chamber Leadless Pacemaker"],"prefix":"10.1161","volume":"18","clinical-trial-number":[{"clinical-trial-number":"nct05252702","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0772-3573","authenticated-orcid":true,"given":"Reinoud E.","family":"Knops","sequence":"first","affiliation":[{"name":"Amsterdam UMC, the Netherlands (R.E.K., K.T.N.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3461-505X","authenticated-orcid":true,"given":"James E.","family":"Ip","sequence":"additional","affiliation":[{"name":"Weill Cornell Medicine\/New York Presbyterian Hospital, NY (J.E.I.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5555-7672","authenticated-orcid":true,"given":"Rahul","family":"Doshi","sequence":"additional","affiliation":[{"name":"HonorHealth Cardiac Arrhythmia Group, Scottsdale, AZ (R.D.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2099-0083","authenticated-orcid":true,"given":"Derek V.","family":"Exner","sequence":"additional","affiliation":[{"name":"Foothills Medical Centre, Calgary, Alberta, Canada (D.V.E.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7183-4278","authenticated-orcid":true,"given":"Pascal","family":"Defaye","sequence":"additional","affiliation":[{"name":"CHRU Albert Michallon, Grenoble, France (P.D.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-5741-7100","authenticated-orcid":true,"given":"Robert","family":"Canby","sequence":"additional","affiliation":[{"name":"Texas Cardiac Arrhythmia Institute, Austin, TX (R.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-4755-1064","authenticated-orcid":true,"given":"Maria Grazia","family":"Bongiorni","sequence":"additional","affiliation":[{"name":"San Rossore Private Hospital and Medical Center, Pisa, Italy (M.G.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1772-6823","authenticated-orcid":true,"given":"Morio","family":"Shoda","sequence":"additional","affiliation":[{"name":"Tokyo Women\u2019s Medical Univ, Tokyo, Japan (M.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0132-0773","authenticated-orcid":true,"given":"Gerhard","family":"Hindricks","sequence":"additional","affiliation":[{"name":"German Heart Center of the Charite, Berlin, Germany (G.H.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4334-8165","authenticated-orcid":true,"given":"Petr","family":"Neu\u017eil","sequence":"additional","affiliation":[{"name":"Na Homolce Hospital, Prague, Czech Republic (P.N., V.Y.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4317-978X","authenticated-orcid":true,"given":"Mayer","family":"Rashtian","sequence":"additional","affiliation":[{"name":"Huntington Memorial Hospital, Pasadena, CA (M.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8637-2099","authenticated-orcid":true,"given":"Karel T.N.","family":"Breeman","sequence":"additional","affiliation":[{"name":"Amsterdam UMC, the Netherlands (R.E.K., K.T.N.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-9296-3634","authenticated-orcid":true,"given":"Jordan R.","family":"Nevo","sequence":"additional","affiliation":[{"name":"Abbott Medical, Sylmar, CA (J.R.N., L.G., C.H., A.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonard","family":"Ganz","sequence":"additional","affiliation":[{"name":"Abbott Medical, Sylmar, CA (J.R.N., L.G., C.H., A.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chris","family":"Hubbard","sequence":"additional","affiliation":[{"name":"Abbott Medical, Sylmar, CA (J.R.N., L.G., C.H., A.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anu","family":"Bulusu","sequence":"additional","affiliation":[{"name":"Abbott Medical, Sylmar, CA (J.R.N., L.G., C.H., A.B.)."}],"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":"Na Homolce Hospital, Prague, Czech Republic (P.N., V.Y.R.)."},{"name":"Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, NY (V.Y.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2011.12.014"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1507192"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1511643"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacep.2023.01.031"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2017.01.035"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2018.08.005"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1540-8159.2011.03150.x"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2300080"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2024.04.091"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCEP.122.010909"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.124.069006"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacep.2021.11.002"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehae101"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2022.09.019"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/eht511"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2023.04.005"}],"container-title":["Circulation: Arrhythmia and Electrophysiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/CIRCEP.124.013619","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,15]],"date-time":"2025-04-15T18:00:41Z","timestamp":1744740041000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCEP.124.013619"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,4]]},"references-count":16,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2025,4]]}},"alternative-id":["10.1161\/CIRCEP.124.013619"],"URL":"https:\/\/doi.org\/10.1161\/circep.124.013619","relation":{},"ISSN":["1941-3149","1941-3084"],"issn-type":[{"value":"1941-3149","type":"print"},{"value":"1941-3084","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,4]]},"assertion":[{"value":"2024-09-09","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-03-12","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-03-27","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}