Comparison of the PolarX and the Arctic Front cryoballoon for pulmonary vein isolation in patients with symptomatic paroxysmal atrial fibrillation (COMPARE CRYO) - Study protocol for a randomized controlled trial.
INTRODUCTION Single-shot devices are increasingly used for pulmonary vein isolation (PVI) in atrial fibrillation (AF). The Arctic Front cryoballoon (Medtronic) is the most frequently used single-shot technology. A recently developed novel cryoballoon has been introduced (PolarX, Boston Scientific) w...
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ftunivbern:oai:boris.unibe.ch:186392 2023-12-24T10:12:25+01:00 Comparison of the PolarX and the Arctic Front cryoballoon for pulmonary vein isolation in patients with symptomatic paroxysmal atrial fibrillation (COMPARE CRYO) - Study protocol for a randomized controlled trial. Maurhofer, Jens Kueffer, Thomas Knecht, Sven Madaffari, Antonio Badertscher, Patrick Seiler, Jens Krisai, Philipp Jufer, Corinne Asatryan, Babken Heg, Dik Servatius, Helge Tanner, Hildegard Kühne, Michael Roten, Laurent Sticherling, Christian Reichlin, Tobias 2023-11 application/pdf https://boris.unibe.ch/186392/1/1-s2.0-S1551714423002641-main.pdf https://boris.unibe.ch/186392/8/Maurhofer_ContempClinTrials_2023.pdf https://boris.unibe.ch/186392/ eng eng Elsevier https://boris.unibe.ch/186392/ info:eu-repo/semantics/embargoedAccess info:eu-repo/semantics/restrictedAccess Maurhofer, Jens; Kueffer, Thomas; Knecht, Sven; Madaffari, Antonio; Badertscher, Patrick; Seiler, Jens; Krisai, Philipp; Jufer, Corinne; Asatryan, Babken; Heg, Dik; Servatius, Helge; Tanner, Hildegard; Kühne, Michael; Roten, Laurent; Sticherling, Christian; Reichlin, Tobias (2023). Comparison of the PolarX and the Arctic Front cryoballoon for pulmonary vein isolation in patients with symptomatic paroxysmal atrial fibrillation (COMPARE CRYO) - Study protocol for a randomized controlled trial. Contemporary clinical trials, 134, p. 107341. Elsevier 10.1016/j.cct.2023.107341 <http://dx.doi.org/10.1016/j.cct.2023.107341> 610 Medicine & health info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion PeerReviewed 2023 ftunivbern https://doi.org/10.1016/j.cct.2023.107341 2023-11-27T00:50:40Z INTRODUCTION Single-shot devices are increasingly used for pulmonary vein isolation (PVI) in atrial fibrillation (AF). The Arctic Front cryoballoon (Medtronic) is the most frequently used single-shot technology. A recently developed novel cryoballoon has been introduced (PolarX, Boston Scientific) with the aim to address limitations of the Arctic Front system. METHODS COMPARE CRYO is a multicentre, randomized, controlled trial with blinded endpoint adjudication by an independent clinical events committee. A total of 200 patients with paroxysmal AF undergoing their first PVI are randomized 1:1 between PolarX cryoballoon ablation and Arctic Front cryoballoon ablation. Continuous monitoring during follow-up is performed using an implantable cardiac monitor (ICM) in all patients. The primary endpoint is time to first recurrence of any atrial tachyarrhythmia (AF, atrial flutter, and/or atrial tachycardia) ≥ 120 s between days 91 and 365 post ablation as detected on the (ICM). Procedural safety is assessed by a composite of cardiac tamponade, persistent phrenic nerve palsy >24 h, vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula or death occurring during or up to 30 days after the procedure. Key secondary endpoints include (Chung et al., 2020 (1)) procedure and fluoroscopy times, Wolf et al. (1991) (2) AF burden, Wang et al. (2003) (3) proportion of patients with recurrence in the blanking period, Benjamin et al. (1998) (4) proportion of patients undergoing repeat ablation, and (Chen et al., 2013 (5)) quality of life changes at 12 months compared to baseline. CONCLUSION COMPARE CRYO will compare the efficacy and safety of the novel PolarX cryoballoon and the standard-of-practice Arctic Front cryoballoon for first PVI performed in patients with symptomatic paroxysmal AF. TRIAL REGISTRATION (ClinicalTrials.gov ID: NCT04704986). Article in Journal/Newspaper Arctic Arctic BORIS (Bern Open Repository and Information System, University of Bern) Arctic PNAS Nexus 2 5 |
institution |
Open Polar |
collection |
BORIS (Bern Open Repository and Information System, University of Bern) |
op_collection_id |
ftunivbern |
language |
English |
topic |
610 Medicine & health |
spellingShingle |
610 Medicine & health Maurhofer, Jens Kueffer, Thomas Knecht, Sven Madaffari, Antonio Badertscher, Patrick Seiler, Jens Krisai, Philipp Jufer, Corinne Asatryan, Babken Heg, Dik Servatius, Helge Tanner, Hildegard Kühne, Michael Roten, Laurent Sticherling, Christian Reichlin, Tobias Comparison of the PolarX and the Arctic Front cryoballoon for pulmonary vein isolation in patients with symptomatic paroxysmal atrial fibrillation (COMPARE CRYO) - Study protocol for a randomized controlled trial. |
topic_facet |
610 Medicine & health |
description |
INTRODUCTION Single-shot devices are increasingly used for pulmonary vein isolation (PVI) in atrial fibrillation (AF). The Arctic Front cryoballoon (Medtronic) is the most frequently used single-shot technology. A recently developed novel cryoballoon has been introduced (PolarX, Boston Scientific) with the aim to address limitations of the Arctic Front system. METHODS COMPARE CRYO is a multicentre, randomized, controlled trial with blinded endpoint adjudication by an independent clinical events committee. A total of 200 patients with paroxysmal AF undergoing their first PVI are randomized 1:1 between PolarX cryoballoon ablation and Arctic Front cryoballoon ablation. Continuous monitoring during follow-up is performed using an implantable cardiac monitor (ICM) in all patients. The primary endpoint is time to first recurrence of any atrial tachyarrhythmia (AF, atrial flutter, and/or atrial tachycardia) ≥ 120 s between days 91 and 365 post ablation as detected on the (ICM). Procedural safety is assessed by a composite of cardiac tamponade, persistent phrenic nerve palsy >24 h, vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula or death occurring during or up to 30 days after the procedure. Key secondary endpoints include (Chung et al., 2020 (1)) procedure and fluoroscopy times, Wolf et al. (1991) (2) AF burden, Wang et al. (2003) (3) proportion of patients with recurrence in the blanking period, Benjamin et al. (1998) (4) proportion of patients undergoing repeat ablation, and (Chen et al., 2013 (5)) quality of life changes at 12 months compared to baseline. CONCLUSION COMPARE CRYO will compare the efficacy and safety of the novel PolarX cryoballoon and the standard-of-practice Arctic Front cryoballoon for first PVI performed in patients with symptomatic paroxysmal AF. TRIAL REGISTRATION (ClinicalTrials.gov ID: NCT04704986). |
format |
Article in Journal/Newspaper |
author |
Maurhofer, Jens Kueffer, Thomas Knecht, Sven Madaffari, Antonio Badertscher, Patrick Seiler, Jens Krisai, Philipp Jufer, Corinne Asatryan, Babken Heg, Dik Servatius, Helge Tanner, Hildegard Kühne, Michael Roten, Laurent Sticherling, Christian Reichlin, Tobias |
author_facet |
Maurhofer, Jens Kueffer, Thomas Knecht, Sven Madaffari, Antonio Badertscher, Patrick Seiler, Jens Krisai, Philipp Jufer, Corinne Asatryan, Babken Heg, Dik Servatius, Helge Tanner, Hildegard Kühne, Michael Roten, Laurent Sticherling, Christian Reichlin, Tobias |
author_sort |
Maurhofer, Jens |
title |
Comparison of the PolarX and the Arctic Front cryoballoon for pulmonary vein isolation in patients with symptomatic paroxysmal atrial fibrillation (COMPARE CRYO) - Study protocol for a randomized controlled trial. |
title_short |
Comparison of the PolarX and the Arctic Front cryoballoon for pulmonary vein isolation in patients with symptomatic paroxysmal atrial fibrillation (COMPARE CRYO) - Study protocol for a randomized controlled trial. |
title_full |
Comparison of the PolarX and the Arctic Front cryoballoon for pulmonary vein isolation in patients with symptomatic paroxysmal atrial fibrillation (COMPARE CRYO) - Study protocol for a randomized controlled trial. |
title_fullStr |
Comparison of the PolarX and the Arctic Front cryoballoon for pulmonary vein isolation in patients with symptomatic paroxysmal atrial fibrillation (COMPARE CRYO) - Study protocol for a randomized controlled trial. |
title_full_unstemmed |
Comparison of the PolarX and the Arctic Front cryoballoon for pulmonary vein isolation in patients with symptomatic paroxysmal atrial fibrillation (COMPARE CRYO) - Study protocol for a randomized controlled trial. |
title_sort |
comparison of the polarx and the arctic front cryoballoon for pulmonary vein isolation in patients with symptomatic paroxysmal atrial fibrillation (compare cryo) - study protocol for a randomized controlled trial. |
publisher |
Elsevier |
publishDate |
2023 |
url |
https://boris.unibe.ch/186392/1/1-s2.0-S1551714423002641-main.pdf https://boris.unibe.ch/186392/8/Maurhofer_ContempClinTrials_2023.pdf https://boris.unibe.ch/186392/ |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic Arctic |
genre_facet |
Arctic Arctic |
op_source |
Maurhofer, Jens; Kueffer, Thomas; Knecht, Sven; Madaffari, Antonio; Badertscher, Patrick; Seiler, Jens; Krisai, Philipp; Jufer, Corinne; Asatryan, Babken; Heg, Dik; Servatius, Helge; Tanner, Hildegard; Kühne, Michael; Roten, Laurent; Sticherling, Christian; Reichlin, Tobias (2023). Comparison of the PolarX and the Arctic Front cryoballoon for pulmonary vein isolation in patients with symptomatic paroxysmal atrial fibrillation (COMPARE CRYO) - Study protocol for a randomized controlled trial. Contemporary clinical trials, 134, p. 107341. Elsevier 10.1016/j.cct.2023.107341 <http://dx.doi.org/10.1016/j.cct.2023.107341> |
op_relation |
https://boris.unibe.ch/186392/ |
op_rights |
info:eu-repo/semantics/embargoedAccess info:eu-repo/semantics/restrictedAccess |
op_doi |
https://doi.org/10.1016/j.cct.2023.107341 |
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