Robot-Assisted Transcranial Doppler Versus Transthoracic Echocardiography for Right to Left Shunt Detection.

"Disclosures Drs Alexandrov, Rubin, Tsivgoulis, and Volpi have received payment as consultants to the study sponsor. C. Douville has received travel support from the study sponsor. The other authors report no conflicts."

"Sources of Funding This work was funded by NeuraSignal, Inc."

"The study was a multicenter (conducted within 6 clinical sites), prospective, single-arm, nonsignificant risk, consecutively enrolled diagnostic yield device clinical trial. The trial was run between October 6, 2020 and October 21, 2021. Specific details about methodology, including prespecified outcomes, were published previously. This trial was registered with ClinicalTrials.gov (https://www.clinicaltrials.gov; Unique identifier: NCT04604015). The trial and protocol were designed by an academic steering committee. The funders, NeuraSignal, Inc, had no influence on the final design or conduct of the trial, in the writing of the article, or in the decision to submit it for publication. The trial protocol (available in full in the Supplemental Material), and informed consent forms were reviewed and approved by central and institutional internal review boards as appropriate at each study site. The trial was performed in accordance with the principles of the Declaration of Helsinki. The trial was designed to align with STARD (Standards for Reporting of Diagnostic Accuracy Studies), standards of device accuracy trials and the checklist available with Supplemental Material. The authors assume responsibility for the accuracy and completeness of the data and analyses, and for the fidelity of the trial and this report to the protocol. REGISTRATION:: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04604015."