Comparison of Axillary Vein Puncture With Subclavian Vein Puncture in Pacemaker Implantation

Not Applicable

• Conditions: Mechanical Complication of Cardiac Pacemaker
• Interventions: Device: Placement of electrode lead through axillary vein puncture; Device: Placement of electrode lead through subclavian vein puncture

• Registration Number: NCT02358551
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

The intrathoracic subclavian venous technique for pacemaker implantation may be associated with serious complications. Axillary vein puncture tends to reduce lead implantation complications such as pneumothorax and lead crush, but clinical adoption is not widely acknowledged, especially in China, although this approach has been proposed for 20 years. The major concern is the learning curve for axillary vein puncture and its success rate. The investigators try to prove that the success rate of axillary vein puncture is non-inferior to subclavian vein puncture, hence to promote the clinical application of axillary vein puncture to reduce pacemaker implantation complications.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-01-25
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-03
• Last Update Submitted: 2015-02-03
• Study First Posted: 2015-02-09
• Last Update Posted: 2015-02-09
• Primary Completion: 2017-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Patients with indication of pacemaker or ICD implantation
• Personally signed and dated informed consent document

Exclusion Criteria

• Accompanied with malignant disease or other disease, which cause life expectancy < 1 year.
• Anatomical variation of axillary vein or subclavian vein, unable to puncture.
• Poor compliance for follow-up.
• Patients with any condition which, in the investigator's judgment, not suitable for enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Axillary vein	Placement of electrode lead through axillary vein puncture	Lead Placement Through the Axillary Vein Technique
Subclaivan vein	Placement of electrode lead through subclavian vein puncture	Lead Placement Through the Subclavian Vein Technique

Primary Outcome Measures

Name	Time	Method
Success rate of vein puncture	1 Day

Secondary Outcome Measures

Name	Time	Method
Duration of pacemaker implantation	1 Day
Mechanical complication of electrode lead (combined endpoints of hemothorax, pneumothorax, air embolism, inadvertent arterial puncture, hematoma, fracture of electrode lead, nerve injury and subclavian crush syndrome)	6 months

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, China