Status:
COMPLETED
Feasibility Study for Instant Cardiac Diagnostic and Post-operative Risk Assessment with the LynxPatch Device
Lead Sponsor:
Lynx Health Science GmbH
Collaborating Sponsors:
Meditrial Europe Ltd.
Conditions:
Cardiovascular Diseases
Heart Diseases
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 2 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 20 2024
Estimated Enrollment :
1097 Patients enrolled
Trial Details
Trial ID
NCT05987904
Start Date
October 2 2023
End Date
June 20 2024
Last Update
October 30 2024
Active Locations (1)
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1
Med. Klinik II - Kardiologie und Angiologie
Bochum, Germany, 44789