An observational study in Cardiovascular Diseases and Heart Diseases, sponsored by Lynx Health Science GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by Lynx Health Science GmbH · Observational
In this clinical study the investigators will evaluate if it is feasible to pre-operatively identify low-risk patients, and to identify patients with cardiac pathologies with the LynxPatch.
The LynxPatch is a non-invasive, wireless device for cardiac diagnosis. The aim of this study is to compare the LynxPatch predictions with the echocardiographic diagnoses of cardiac pathologies and to evaluate its perioperative risk predictions in non-cardiac surgeries. The study population includes 1100 patients that scheduled for an echocardiographic assessment or for a non-cardiac surgery. The LynxPatch measurement procedure has a duration of about 30 minutes.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 1,097 is above the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →This is the only study on the registry with Lynx Health Science GmbH as lead sponsor.
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In this study, all patients will be consecutively recruited that are either scheduled for an echocardiographic examination or that will be subjected to a non-cardiac surgical procedure according to their respective standard procedure.
Exclusion Criteria:
This group includes patients who are scheduled for echocardiography.
Device: LynxPatch
This group includes patients that are scheduled for non-cardiac surgery.
Device: LynxPatch
Measurements with the LynxPatch device are conducted.
Level of agreement between the LynxPatch device and echocardiography in detecting a cardiac pathology.
Comparison of the detection of the presence of a cardiac pathology by the LynxPatch device and by echocardiography-based expert diagnosis.
Time frame: 30 minutes per individual
Accuracy of the LynxPatch device predictions of an adverse perioperative outcome
Comparison of the LynxPatch device predictions of an adverse perioperative outcome with actually occuring adverse perioperative outcome.
Time frame: 30 days per individual
Usability of the LynxPatch device
Evaluation of aspects of the LynxPatch device's usability by interviewing study participants using a questionnaire.
Time frame: 30 minutes per individual
Rate of LynxPatch-related safety incidents
Assessment of safety-related aspects with the LynxPatch device. Relevant incidents include Adverse Device Effects, Serious Adverse Device Effects and Device Defficiencies.
Time frame: 30 minutes per individual
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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