CT Data Collection Study

Completed

• Conditions: Cardiac Disease

• Registration Number: NCT03589664
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary

The primary objective of this study is to gather chest CT images as part of routine clinical procedure from subjects with and without prior sternotomy to characterize the substernal space. Specifically, the study will provide references for physicians to better understand substernal anatomy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-20
• Study First Submitted QC: 2018-07-05
• Study First Posted: 2018-07-18
• Study Start: 2018-07-20
• Primary Completion: 2019-12-15
• Study Completion: 2019-12-15
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-12
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Subject must be≥18 years old
• Subject must be indicated for high quality chest CT imaging as part of routine clinical procedure
• Subject must be willing to provide Informed Consent

Exclusion Criteria

• Subject has medical conditions that would limit study participation
• Subject is pregnant or have a pregnancy plan during the study
• Subject is enrolled in a concurrent study that may confound the results of this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CT imaging data	At enrollment	High quality CT images

Trial Locations

Locations (1)

TongRen Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China