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The DOI matches its Crossref record; 8 of the 8 references it cites were found in a registry or an index.

A leadless pacemaker in the real-world setting: The Micra Transcatheter Pacing System Post-Approval Registry

Open access
Roberts, Paul R., Clementy, Nicolas, Al Samadi, Faisal, Garweg, Christophe, Martinez-Sande, Jose Luis, Iacopino, Saverio, Johansen, Jens Brock, Vinolas Prat, Xavier, Kowal, Robert C., Klug, Didier, Mont, Lluis, Steffel, Jan, Li, Shelby, Van Osch, Dirk, El-Chami, Mikhael F.·2017·Heart Rhythm
DOI 10.1016/j.hrthm.2017.05.017
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Abstract

BACKGROUND: First-in-man studies of leadless pacemakers have demonstrated high rates of implant success, and safety and efficacy objectives were achieved. Outside of the investigational setting, there are concerns, particularly over cardiac effusion and perforation, device dislodgement, infection, telemetry, and battery issues. OBJECTIVE: The acute performance of the Micra transcatheter pacemaker from a worldwide Post-Approval Registry is reported. METHODS: The registry is an ongoing prospective single-arm observational study designed to assess the safety and effectiveness of Micra in the post-approval setting. The safety end point was system- or procedure-related major complications at 30 days post implant. We compared the major complication rate with that of the 726 patients from the investigational study. Electrical performance was also characterized. RESULTS: The device was successfully implanted in 792 of 795 registry patients (99.6%) by 149 implanters at 96 centers in 20 countries. Through 30 days post implant, a total of 13 major complications occurred in 12 patients, for a major complication rate of 1.51% (95% confidence interval, 0.78%-2.62%). Major complications included cardiac effusion/perforation (1, 0.13%), device dislodgement (1, 0.13%), and sepsis (1, 0.13%). After adjusting for baseline differences, the rate of major complications in the registry trended lower than the investigational trial (odds ratio, 0.58, 95% confidence interval, 0.27-1.25; P = .16). Early pacing capture thresholds were low and stable. CONCLUSION: Performance of the Micra transcatheter pacemaker in a real-world setting demonstrates a high rate (99.6%) of implant success and low rate (1.51%) of major complications through 30 days post implant. In particular, the rates of pericardial effusion, device dislodgement, and infection were low, reinforcing the positive results seen in the investigational study.

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Metadata

Authors
Roberts, P. R., Clementy, N., Al Samadi, F., Garweg, C., Martinez-Sande, J. L., Iacopino, S., Johansen, J. B., Vinolas Prat, X., Kowal, R. C., Klug, D., Mont, L., Steffel, J., Li, S., Van Osch, D., & El-Chami, M. F.
Venue
Heart Rhythm
Publisher
Elsevier BV
Published
2017-09
Volume
14
Issue
9
Pages
1375-1379
ISSN
1547-5271 (ISSN-L)
DOI
10.1016/j.hrthm.2017.05.017
OpenAlex
W2612818999
Cited by
332
References
8
FWCI
26.27
Type
journal article
Language
en
Open access
hybrid

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CoChat. (2026). Citation check: A leadless pacemaker in the real-world setting: The Micra Transcatheter Pacing System Post-Approval Registry. https://app.cochat.ai/papers/10.1016/j.hrthm.2017.05.017
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Roberts, P. R., Clementy, N., Al Samadi, F., Garweg, C., Martinez-Sande, J. L., Iacopino, S., Johansen, J. B., Vinolas Prat, X., Kowal, R. C., Klug, D., Mont, L., Steffel, J., Li, S., Van Osch, D., & El-Chami, M. F. (2017). A leadless pacemaker in the real-world setting: The Micra Transcatheter Pacing System Post-Approval Registry. Heart Rhythm. https://doi.org/10.1016/j.hrthm.2017.05.017

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.