CT Data Collection Study | NCT03589664

Studies
CT Data Collection Study

NCT03589664

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Status

Completed

Last Update Posted

Oct 14, 2020Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Cardiac Disease

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2018Actual

Primary Completion Date

Dec 15, 2019Actual

Completion Date

Dec 15, 2019Actual

First Submitted Date

Jun 20, 2018

First Submission Date that Met QC Criteria

Jul 5, 2018

First Posted Date

Jul 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2020

Last Update Posted Date

Oct 14, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-Sternotomy Group		Subjects who have no prior sternotomy
Sternotomy Group		Subjects who previously underwent a sternotomy procedure.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CT imaging data	High quality CT images	At enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

The study will enroll up to 100 patients who have taken or plan to take chest CT images during routine clinical procedure. The subjects will be divided into sternotomy group and non-sternotomy group based on whether the subject had undergone sternotomy.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zhaohui Qiu	Shanghai Tong Ren Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
TongRen Hospital, Shanghai Jiao Tong University School of Medicine		Shanghai			China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided