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

Nanjing Medical University

Status: Unknown

Conditions: Pulmonary Embolism

Treatments: Procedure: temporary pacing subclavian vein; Procedure: temporary pacing femoral vein

Study type: Interventional

Funder types: Other

Identifiers

NCT02430207

KFSN201407

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

Femoral Vein

Experimental group

Description:

patients receiving temporary pacing via femoral vein

Treatment:

Procedure: temporary pacing femoral vein

Subclavian Vein

Experimental group

Description:

patients receiving temporary pacing via subclavian vein

Treatment:

Procedure: temporary pacing subclavian vein