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OpenTrials
Completed

NCT Number: NCT05987904

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

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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Key information

Conditions

Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Med. Klinik II - Kardiologie und Angiologie

Bochum, 44789, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LynxPatch

Device

Measurements with the LynxPatch device are conducted.

Primary outcomes

  1. Level of agreement between the LynxPatch device and echocardiography in detecting a cardiac pathology.

    Time frame: 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 outcomes

  1. Accuracy of the LynxPatch device predictions of an adverse perioperative outcome

    Time frame: 30 days per individual

    Comparison of the LynxPatch device predictions of an adverse perioperative outcome with actually occuring adverse perioperative outcome.

  2. Usability of the LynxPatch device

    Time frame: 30 minutes per individual

    Evaluation of aspects of the LynxPatch device's usability by interviewing study participants using a questionnaire.

  3. Rate of LynxPatch-related safety incidents

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Lynx Health Science GmbH

Industry

Collaborators

  • Meditrial Europe Ltd.

Registry information

Official study title

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

Acronym: LP-I-CARDIAG

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2023
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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