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

Study Overview
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Brief Summary
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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.

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

Conditions
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Mechanical Complication of Cardiac Pacemaker

Intervention / Treatment
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* Device: Placement of electrode lead through axillary vein puncture
* Device: Placement of electrode lead through subclavian vein puncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Axillary vein<br>Lead Placement Through the Axillary Vein Technique | Device: Placement of electrode lead through axillary vein puncture<br> <br> |
| Other: Subclaivan vein<br>Lead Placement Through the Subclavian Vein Technique | Device: Placement of electrode lead through subclavian vein puncture<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of vein puncture |  | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Duration of pacemaker implantation |  | 1 Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pacemaker, Axillary Vein, Subclavian vein, Clinical Study, Cardiovascular implantable electronic devices