Collect Flow and Ultrasound Images of Coronary Bypass Grafts

NCT ID: NCT06360224

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-15
• Study Completion Date: 2029-05-15

Brief Summary

This is a post-market observational, non-interventional, multicenter clinical investigation with the purpose of harvesting high quality data from regular cardiac bypass surgery (CABG).

Conditions

Cardiac Bypass Surgery (CABG)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

MiraQ systems with Transit Time Flow Measurement (TTFM) and High Frequency Ultrasound (HFUS) probes

The objective of this study is to harvest a wide dataset of high quality to allow exploratory analysis and training of machine learning

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient older than 18 years
• Scheduled for CABG
• Understand the nature of the procedure and willingness to comply with the CIP
• Provide written informed consent

Exclusion Criteria

• Patient younger than 18 years
• Any condition that the investigator believes should exclude participation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medistim ASA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Haakon Grøthe

Role: CONTACT

haakon.groethe@medistim.com

04790968263

Other Identifiers

CASES

Identifier Type: -

Identifier Source: org_study_id