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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1097 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-02

Study Completion Date

2024-06-20

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.

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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.

Conditions

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Cardiovascular Diseases Heart Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1: Cardiologic Group

This group includes patients who are scheduled for echocardiography.

LynxPatch

Intervention Type DEVICE

Measurements with the LynxPatch device are conducted.

Group 2: Surgery Group

This group includes patients that are scheduled for non-cardiac surgery.

LynxPatch

Intervention Type DEVICE

Measurements with the LynxPatch device are conducted.

Interventions

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LynxPatch

Measurements with the LynxPatch device are conducted.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No