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

Completed

• Conditions: Cardiovascular Diseases; Heart Diseases
• Interventions: Device: LynxPatch

• Registration Number: NCT05987904
• Lead Sponsor: Lynx Health Science GmbH

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.

Study Timeline

• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2023-08-04
• Study First Posted: 2023-08-14
• Study Start: 2023-10-02
• Primary Completion: 2024-06-20
• Study Completion: 2024-06-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1097

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1: Cardiologic Group	LynxPatch	This group includes patients who are scheduled for echocardiography.
Group 2: Surgery Group	LynxPatch	This group includes patients that are scheduled for non-cardiac surgery.

Primary Outcome Measures

Name	Time	Method
Level of agreement between the LynxPatch device and echocardiography in detecting a cardiac pathology.	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 Outcome Measures

Name	Time	Method
Accuracy of the LynxPatch device predictions of an adverse perioperative outcome	30 days per individual	Comparison of the LynxPatch device predictions of an adverse perioperative outcome with actually occuring adverse perioperative outcome.
Usability of the LynxPatch device	30 minutes per individual	Evaluation of aspects of the LynxPatch device's usability by interviewing study participants using a questionnaire.
Rate of LynxPatch-related safety incidents	30 minutes per individual	Assessment of safety-related aspects with the LynxPatch device. Relevant incidents include Adverse Device Effects, Serious Adverse Device Effects and Device Defficiencies.

Trial Locations

Locations (1)

Med. Klinik II - Kardiologie und Angiologie; 🇩🇪 Bochum, Germany