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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Cardiovascular Diseases
• Intervention / Treatment: Device: 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 Type: Observational
• Enrollment (Actual): 1097

Contacts and Locations

Study Locations

• Germany
  • Bochum, Germany, 44789
    • Med. Klinik II - Kardiologie und Angiologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

In this study, all patients will be consecutively recruited that are either scheduled for an echocardiographic examination or that will be subjected to a non-cardiac surgical procedure according to their respective standard procedure.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1: Cardiologic Group; This group includes patients who are scheduled for echocardiography.	Device: LynxPatch; Measurements with the LynxPatch device are conducted.
Group 2: Surgery Group; This group includes patients that are scheduled for non-cardiac surgery.	Device: LynxPatch; Measurements with the LynxPatch device are conducted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of agreement between the LynxPatch device and echocardiography in detecting a cardiac pathology.	Comparison of the detection of the presence of a cardiac pathology by the LynxPatch device and by echocardiography-based expert diagnosis.	30 minutes per individual

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lynx Health Science GmbH
• Collaborators: Meditrial Europe Ltd.
• Investigators: Principal Investigator: Aydan Ewers, Dr. med., BG Universitätsklinikum Bergmannsheil

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Actual): June 20, 2024
• Study Completion (Actual): June 20, 2024

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2024
• Last Update Submitted That Met QC Criteria: October 28, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Cardiac Diagnosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: MDR LP-I-CARDIAG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No