Feasibility Study for Instant Cardiac Diagnostic and Post-operative Risk Assessment with the LynxPatch Device
LP-I-CARDIAG
MDR - Feasibility Study for Instant Cardiac Diagnostic and Post-operative Risk
1 other identifier
observational
1,097
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedStudy Start
First participant enrolled
October 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2024
CompletedOctober 30, 2024
October 1, 2024
9 months
July 28, 2023
October 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
Group 1: Cardiologic Group
This group includes patients who are scheduled for echocardiography.
Group 2: Surgery Group
This group includes patients that are scheduled for non-cardiac surgery.
Interventions
Measurements with the LynxPatch device are conducted.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lynx Health Science GmbHlead
- Meditrial Europe Ltd.collaborator
Study Sites (1)
Med. Klinik II - Kardiologie und Angiologie
Bochum, 44789, Germany
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Aydan Ewers, Dr. med.
BG Universitätsklinikum Bergmannsheil
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2023
First Posted
August 14, 2023
Study Start
October 2, 2023
Primary Completion
June 20, 2024
Study Completion
June 20, 2024
Last Updated
October 30, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share