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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2017

Interventions

  • Device: Placement of electrode lead through axillary vein puncture
  • Device: Placement of electrode lead through subclavian vein puncture

Arms, Groups and Cohorts

  • Other: Axillary vein
    • Lead Placement Through the Axillary Vein Technique
  • Other: Subclaivan vein
    • Lead Placement Through the Subclavian Vein Technique

Clinical Trial Outcome Measures

Primary Measures

  • Success rate of vein puncture
    • Time Frame: 1 Day

Secondary Measures

  • 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)
    • Time Frame: 6 months
  • Duration of pacemaker implantation
    • Time Frame: 1 Day

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • China-Japan Friendship Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xianlun Li, Deputy Director, Department of Cardiology – China-Japan Friendship Hospital
  • Overall Official(s)
    • Xianlun Li, MD, Principal Investigator, China-Japan Friendship Hospital
  • Overall Contact(s)
    • Xianlun Li, MD, 86-10-84206151, leexianlun@163.com

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