Feasibility Study for Instant Cardiac Diagnostic and Post-operative Risk Assessment with the LynxPatch Device (LP-I-CARDIAG)

Lynx Health Science

Status: Completed

Conditions: Cardiovascular Diseases; Heart Diseases

Treatments: Device: LynxPatch

Study type: Observational

Funder types: Industry

Identifiers

NCT05987904

MDR LP-I-CARDIAG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,097 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,097 participants in 2 patient groups

Group 1: Cardiologic Group

Description:

This group includes patients who are scheduled for echocardiography.

Treatment:

Device: LynxPatch

Group 2: Surgery Group

Description:

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

Treatment:

Device: LynxPatch