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

China-Japan Friendship Hospital

Status: Unknown

Conditions: Mechanical Complication of Cardiac Pacemaker

Treatments: Device: Placement of electrode lead through subclavian vein puncture; Device: Placement of electrode lead through axillary vein puncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02358551

CJFH-2014-086

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Axillary vein

Other group

Description:

Lead Placement Through the Axillary Vein Technique

Treatment:

Device: Placement of electrode lead through axillary vein puncture

Subclaivan vein

Other group

Description:

Lead Placement Through the Subclavian Vein Technique

Treatment:

Device: Placement of electrode lead through subclavian vein puncture