ClinicalTrials.gg
Status unknownNCT02358551Updated Feb 9, 2015

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

An interventional study of Placement of electrode lead through axillary vein puncture and Placement of electrode lead through subclavian vein puncture in Mechanical Complication of Cardiac Pacemaker, sponsored by China-Japan Friendship Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-09.

Sponsored by China-Japan Friendship Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Mechanical Complication of Cardiac Pacemaker

Keywords

  • Pacemaker
  • Axillary Vein
  • Subclavian vein
  • Clinical Study
  • Cardiovascular implantable electronic devices
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In context

Lead sponsor

China-Japan Friendship Hospital is the lead sponsor of 177 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
220 participants (estimated)

Study arms

  • Other
    Axillary vein

    Lead Placement Through the Axillary Vein Technique

    Device: Placement of electrode lead through axillary vein puncture

  • Other
    Subclaivan vein

    Lead Placement Through the Subclavian Vein Technique

    Device: Placement of electrode lead through subclavian vein puncture

Interventions

  • DevicePlacement of electrode lead through axillary vein puncture
  • DevicePlacement of electrode lead through subclavian vein puncture
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What researchers measure

Primary outcomes

  1. Success rate of vein puncture

    Time frame: 1 Day

Secondary outcomes

  1. 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

  2. Duration of pacemaker implantation

    Time frame: 1 Day

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Study locations

1 of 1 sites recruiting
  • China-Japan Friendship Hospital
    Beijing, 100029, China
    Recruiting
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References and documents

Publications

  • Liu P, Zhou YF, Yang P, Gao YS, Zhao GR, Ren SY, Li XL. Optimized Axillary Vein Technique versus Subclavian Vein Technique in Cardiovascular Implantable Electronic Device Implantation: A Randomized Controlled Study. Chin Med J (Engl). 2016 Nov 20;129(22):2647-2651. doi: 10.4103/0366-6999.193462. PubMed 27823994 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02358551
Responsible party
Xianlun Li (Deputy Director, Department of Cardiology, China-Japan Friendship Hospital) — Principal investigator
First posted
Feb 9, 2015
Start date
Jun 2014
Primary completion
Jan 2017 (estimated)
Completion
Jan 2017 (estimated)
Last update
Feb 9, 2015

Study contacts

Xianlun Li, MD
Contact
leexianlun@163.com
86-10-84206151
Peng Liu, MD, PhD
Contact
liupengdoc@gmail.com
86-10-84205136
Xianlun Li, MD
principal investigator · China-Japan Friendship Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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