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

Cardiovascular Diseases Clinical Trial

— LP-I-CARDIAG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05987904
• Other study ID #: MDR LP-I-CARDIAG
• Status: Recruiting
• Start date: October 2, 2023
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: Lynx Health Science GmbH
• Contact: Michael Klum
• Phone: 49 30 814504401
• Email: klum[@]lynx-health.science
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: September 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases

Intervention

Device:
• LynxPatch
Measurements with the LynxPatch device are conducted.

Locations

Country	Name	City	State
Germany	Med. Klinik II - Kardiologie und Angiologie	Bochum

Sponsors (2)

Lead Sponsor	Collaborator
Lynx Health Science GmbH	Meditrial Europe Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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