Publication:
Comparison of Cryoballoon vs. Pulsed Field Ablation in Patients with Symptomatic Paroxysmal Atrial Fibrillation (SINGLE SHOT CHAMPION): Study protocol for a randomized controlled trial.

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datacite.rightsopen.access
dc.contributor.authorMaurhofer, Jens Rudolf
dc.contributor.authorKüffer, Thomas
dc.contributor.authorKnecht, Sven
dc.contributor.authorThalmann, Gregor
dc.contributor.authorBadertscher, Patrick
dc.contributor.authorKozhuharov, Nikola Asenov
dc.contributor.authorKrisai, Philipp
dc.contributor.authorJufer, Corinne
dc.contributor.authorIqbal, Salik Ur Rehman
dc.contributor.authorHeg, Dierik Hans
dc.contributor.authorServatius, Helge Simon
dc.contributor.authorTanner, Hildegard
dc.contributor.authorKühne, Michael
dc.contributor.authorRoten, Laurent
dc.contributor.authorSticherling, Christian
dc.contributor.authorReichlin, Tobias Roman
dc.date.accessioned2024-10-26T18:41:26Z
dc.date.available2024-10-26T18:41:26Z
dc.date.issued2024-07
dc.description.abstractBACKGROUND Single-shot devices are increasingly used for pulmonary vein isolation (PVI) in atrial fibrillation (AF). The Arctic Front cryoballoon is the most frequently used single-shot technology. A recently developed novel pulsed field ablation (PFA) device (FARAPULSE) has been introduced with the aim to improve procedural safety and efficacy. OBJECTIVE This study will compare the novel FARAPULSE PFA device and the Arctic Front cryoballoon for first PVI in patients with symptomatic paroxysmal AF. METHODS SINGLE SHOT CHAMPION is a multicenter, randomized controlled trial with blinded endpoint adjudication by an independent clinical events committee. Overall, 210 patients with paroxysmal AF undergoing their PVI are randomized 1:1 between PFA and cryoballoon ablation. Continuous rhythm monitoring with an implantable cardiac monitor is performed in all patients. RESULTS The primary endpoint is time to first recurrence of any atrial tachyarrhythmia (AF and/or organized atrial tachyarrhythmia) lasting ≥120 seconds and identified by the implantable cardiac monitor within 91 and 365 days postablation. The composite procedural safety endpoint includes cardiac tamponade requiring drainage, persistent phrenic nerve palsy, vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula, and death occurring during or up to 30 days after the procedure. Key secondary endpoints include (1) increase in high-sensitivity troponin on day 1 postablation, (2) analysis of postablation 3-dimensional electroanatomic mapping (first 25 patients per study group), (3) AF burden, and (4) quality-of-life changes. CONCLUSION SINGLE SHOT CHAMPION will evaluate the efficacy and safety of PVI using the novel FARAPULSE PFA for patients with symptomatic paroxysmal AF.
dc.description.numberOfPages8
dc.description.sponsorshipUniversitätsklinik für Kardiologie
dc.description.sponsorshipDepartment of Clinical Research (DCR) - Statistics & Methodology (Heg)
dc.identifier.doi10.48350/199608
dc.identifier.pmid39119022
dc.identifier.publisherDOI10.1016/j.hroo.2024.05.008
dc.identifier.urihttps://boris-portal.unibe.ch/handle/20.500.12422/179668
dc.language.isoen
dc.publisherElsevier
dc.relation.ispartofHeart rhythm O2
dc.relation.issn2666-5018
dc.relation.organizationDCD5A442BB15E17DE0405C82790C4DE2
dc.subjectAtrial fibrillation Cryoballoon ablation Implantable cardiac monitoring Pulmonary vein isolation Pulsed field ablation
dc.subject.ddc600 - Technology::610 - Medicine & health
dc.titleComparison of Cryoballoon vs. Pulsed Field Ablation in Patients with Symptomatic Paroxysmal Atrial Fibrillation (SINGLE SHOT CHAMPION): Study protocol for a randomized controlled trial.
dc.typearticle
dspace.entity.typePublication
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oaire.citation.endPage467
oaire.citation.issue7
oaire.citation.startPage460
oaire.citation.volume5
oairecerif.author.affiliationUniversitätsklinik für Kardiologie
oairecerif.author.affiliationUniversitätsklinik für Kardiologie
oairecerif.author.affiliationUniversitätsklinik für Kardiologie
oairecerif.author.affiliationUniversitätsklinik für Kardiologie
oairecerif.author.affiliationUniversitätsklinik für Kardiologie
oairecerif.author.affiliationUniversitätsklinik für Kardiologie
oairecerif.author.affiliationDepartment of Clinical Research (DCR) - Statistics & Methodology (Heg)
oairecerif.author.affiliationUniversitätsklinik für Kardiologie
oairecerif.author.affiliationUniversitätsklinik für Kardiologie
oairecerif.author.affiliationUniversitätsklinik für Kardiologie
oairecerif.author.affiliationUniversitätsklinik für Kardiologie
oairecerif.author.affiliation2Clinical Trials Unit Bern (CTU) - Statistics & Methodology (Heg)
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unibe.date.licenseChanged2024-08-09 14:51:48
unibe.description.ispublishedpub
unibe.eprints.legacyId199608
unibe.refereedtrue
unibe.subtype.articlecontribution

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