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NCT03589664 Clinical Trial

CT Data Collection Study

Cardiac Disease Clinical Trial

Official title:
Computed Tomography Data Collection for Anatomical Analysis of Substernal Space in Patients With Cardiovascular Diseases

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03589664
Other study ID # CT Data Collection Study
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 20, 2018
Est. completion date December 15, 2019

Study information
Verified date October 2020
Source Medtronic Cardiac Rhythm and Heart Failure
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 15, 2019
Est. primary completion date December 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
China TongRen Hospital, Shanghai Jiao Tong University School of Medicine Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary CT imaging data High quality CT images At enrollment
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