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| Name | Class |
|---|---|
| Meditrial Europe Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Cardiologic Group | This group includes patients who are scheduled for echocardiography. |
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| Group 2: Surgery Group | This group includes patients that are scheduled for non-cardiac surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LynxPatch | Device | Measurements with the LynxPatch device are conducted. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 minutes per individual |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days per individual |
| Usability of the LynxPatch device |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Aydan Ewers, Dr. med. | BG Universitätsklinikum Bergmannsheil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Med. Klinik II - Kardiologie und Angiologie | Bochum | 44789 | Germany |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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Evaluation of aspects of the LynxPatch device's usability by interviewing study participants using a questionnaire. |
| 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. | 30 minutes per individual |