Maurhofer, Jens; Kueffer, Thomas; Knecht, Sven; Thalmann, Gregor; Badertscher, Patrick; Kozhuharov, Nikola; Krisai, Philipp; Jufer, Corinne; Iqbal, Salik Ur Rehman; Heg, Dik; Servatius, Helge; Tanner, Hildegard; Kühne, Michael; Roten, Laurent; Sticherling, Christian; Reichlin, Tobias (2024). Comparison of Cryoballoon vs. Pulsed Field Ablation in Patients with Symptomatic Paroxysmal Atrial Fibrillation (SINGLE SHOT CHAMPION): Study protocol for a randomized controlled trial. Heart rhythm O2, 5(7), pp. 460-467. Elsevier 10.1016/j.hroo.2024.05.008
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BACKGROUND
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.
Item Type: |
Journal Article (Further Contribution) |
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Division/Institute: |
04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology |
UniBE Contributor: |
Maurhofer, Jens Rudolf, Kueffer, Thomas, Thalmann, Gregor, Kozhuharov, Nikola Asenov, Jufer, Corinne, Iqbal, Salik Ur Rehman, Heg, Dierik Hans, Servatius, Helge Simon (B), Tanner, Hildegard, Roten, Laurent, Reichlin, Tobias Roman |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
2666-5018 |
Publisher: |
Elsevier |
Language: |
English |
Submitter: |
Pubmed Import |
Date Deposited: |
09 Aug 2024 16:43 |
Last Modified: |
09 Aug 2024 16:51 |
Publisher DOI: |
10.1016/j.hroo.2024.05.008 |
PubMed ID: |
39119022 |
Uncontrolled Keywords: |
Atrial fibrillation Cryoballoon ablation Implantable cardiac monitoring Pulmonary vein isolation Pulsed field ablation |
BORIS DOI: |
10.48350/199608 |
URI: |
https://boris.unibe.ch/id/eprint/199608 |
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