Incidence of Pulmonary Embolism During Temporary Pacing V... | NCT02430207

Studies
Incidence of Pulmonary Embolism During Temporary Pacing Via Femoral Versus Subclavian Vein

NCT02430207

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Status

Unknown status

Last Update Posted

Feb 19, 2016Estimated

Enrollment

360Estimated

Phase

Not Applicable

Conditions

Pulmonary Embolism

Interventions

temporary pacing femoral vein
temporary pacing subclavian vein

Countries

Not provided

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

Apr 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

May 2016Estimated

Completion Date

Not provided

First Submitted Date

Apr 21, 2015

First Submission Date that Met QC Criteria

Apr 29, 2015

First Posted Date

Apr 30, 2015Estimated

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

Feb 18, 2016

Last Update Posted Date

Feb 19, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Minglong Chen, Vice Director of Division of Cardiology, The First Affiliated Hospital of Nanjing Medical University; Professor of Medicine, Nanjing Medical University, The First Affiliated Hospital with Nanjing Medical UniversityPrincipal Investigator

Lead Sponsor

The First Affiliated Hospital with Nanjing Medical UniversityOTHER

Collaborators

Name	Class
Suqian People's Hospital	UNKNOWN
The First People's Hospital of Kunshan	OTHER
Danyang People's Hospital of Jiangsu Province	UNKNOWN
Jiangsu Taizhou People's Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Temporary pacing via femoral vein is used widely in mainland China, because of its feasibility and simplicity. However, pulmonary embolism often occurred after the procedure. It is not known that whether there was any difference in incidence of pulmonary embolism between via different approaches. This randomized and multi-center study was designed to verify whether temporary pacing via subclavian vein has lower incidence than via femoral vein.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

360Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Femoral Vein	Experimental	patients receiving temporary pacing via femoral vein	Procedure: temporary pacing femoral vein
Subclavian Vein	Experimental	patients receiving temporary pacing via subclavian vein	Procedure: temporary pacing subclavian vein

Interventions

Name	Type	Description	Arm Group Labels	Other Names
temporary pacing femoral vein	Procedure	Temporary pacing via femoral or subclavian vein	Femoral Vein

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of participants suffering from pulmonary embolism		12 hours to 7 days after extraction of temporary pacing leads

Secondary Outcomes

Measure	Description	Time Frame
Percentage of participants suffering from deep vein thrombosis		12 hours to 7 days after extraction of temporary pacing leads

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years old or older
There is indication for temporary pacing
Patients agreed to participate in the clinical trial and sign a written informed consent

Exclusion Criteria:

History of pulmonary embolism or deep vein thrombosis
Devices existing in vein system
Patients who could not receive randomization
Severe coagulation disorder
Severe liver, kidney dysfunction
Mental diseases
Pregnancy
Patients investigators believed not suitable for enrollment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kai Gu, M.D.	Contact	0086 25 68136965		gukaiwang@163.com

Overall Officials

Name	Affiliation	Role
Minglong Chen, M.D.	The First Affiliated Hospital with Nanjing Medical University	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
13002611	Background	ZOLL PM. Resuscitation of the heart in ventricular standstill by external electric stimulation. N Engl J Med. 1952 Nov 13;247(20):768-71. doi: 10.1056/NEJM195211132472005. No abstract available.
10814641	Background	Gammage MD. Temporary cardiac pacing. Heart. 2000 Jun;83(6):715-20. doi: 10.1136/heart.83.6.715. No abstract available.

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D004617	Embolism
D016769	Embolism and Thrombosis