Feasibility Study for Instant Cardiac Diagnostic and Post-operative Risk Assessment With the LynxPatch Device

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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MDR - Feasibility Study for Instant Cardiac Diagnostic and Post-operative Risk

Conditions
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Cardiovascular Diseases, Heart Diseases

Intervention / Treatment
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* Device: LynxPatch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent, i.e., the subject must be able to understand and sign the Patient Information and Consent Form. Group 1: Patients that have an indication for an echocardiographic assessment. Group 2: Patients that are scheduled for a non-cardiac surgery Exclusion Criteria: Subjects has implanted cardioverter defibrillator Subject is pregnant Subject is breastfeeding Subject has compromised skin in the location where the LynxPatch is intended to be positioned

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: Cardiologic Group<br>This group includes patients who are scheduled for echocardiography. | Device: LynxPatch<br>* Measurements with the LynxPatch device are conducted.<br>|
| Group 2: Surgery Group<br>This group includes patients that are scheduled for non-cardiac surgery. | Device: LynxPatch<br>* Measurements with the LynxPatch device are conducted.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Diagnosis