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

MDR - Feasibility Study for Instant Cardiac Diagnostic and Post-operative Risk

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05987904

Acronym

LP-I-CARDIAG

Enrollment

1097

Registered

2023-08-14

Start date

2023-10-02

Completion date

2024-06-20

Last updated

2024-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Heart Diseases

Keywords

Cardiac Diagnosis

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.

Interventions

DEVICELynxPatch

Measurements with the LynxPatch device are conducted.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026