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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2015 by Xianlun Li, China-Japan Friendship Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02358551
First Posted: February 9, 2015
Last Update Posted: February 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Xianlun Li, China-Japan Friendship Hospital
January 25, 2015
February 9, 2015
February 9, 2015
June 2014
January 2017   (Final data collection date for primary outcome measure)
Success rate of vein puncture [ Time Frame: 1 Day ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison of Axillary Vein Puncture With Subclavian Vein Puncture in Pacemaker Implantation
Comparison of Axillary Vein Puncture With Subclavian Vein Puncture in Pacemaker Implantation
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Mechanical Complication of Cardiac Pacemaker
  • Device: Placement of electrode lead through axillary vein puncture
  • Device: Placement of electrode lead through subclavian vein puncture
  • Axillary vein
    Lead Placement Through the Axillary Vein Technique
    Intervention: Device: Placement of electrode lead through axillary vein puncture
  • Subclaivan vein
    Lead Placement Through the Subclavian Vein Technique
    Intervention: Device: Placement of electrode lead through subclavian vein puncture
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
220
January 2017
January 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT02358551
CJFH-2014-086
Yes
Not Provided
Not Provided
Xianlun Li, China-Japan Friendship Hospital
China-Japan Friendship Hospital
Not Provided
Principal Investigator: Xianlun Li, MD China-Japan Friendship Hospital
China-Japan Friendship Hospital
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP