MDR - Feasibility Study for Instant Cardiac Diagnostic and Post-operative Risk
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- Lynx Health Science GmbH
- Enrollment
- 1097
- Locations
- 1
- Primary Endpoint
- Level of agreement between the LynxPatch device and echocardiography in detecting a cardiac pathology.
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Level of agreement between the LynxPatch device and echocardiography in detecting a cardiac pathology.
Time Frame: 30 minutes per individual
Comparison of the detection of the presence of a cardiac pathology by the LynxPatch device and by echocardiography-based expert diagnosis.
Secondary Outcomes
- Accuracy of the LynxPatch device predictions of an adverse perioperative outcome(30 days per individual)
- Usability of the LynxPatch device(30 minutes per individual)
- Rate of LynxPatch-related safety incidents(30 minutes per individual)