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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 China-Japan Friendship Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Xianlun Li, China-Japan Friendship Hospital
ClinicalTrials.gov Identifier:
NCT02358551
First received: January 25, 2015
Last updated: February 3, 2015
Last verified: February 2015
  Purpose
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.

Condition Intervention
Mechanical Complication of Cardiac Pacemaker
Device: Placement of electrode lead through axillary vein puncture
Device: Placement of electrode lead through subclavian vein puncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Axillary Vein Puncture With Subclavian Vein Puncture in Pacemaker Implantation

Further study details as provided by China-Japan Friendship Hospital:

Primary Outcome Measures:
  • Success rate of vein puncture [ Time Frame: 1 Day ]

Secondary Outcome 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 ]

Estimated Enrollment: 220
Study Start Date: June 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Axillary vein
Lead Placement Through the Axillary Vein Technique
Device: Placement of electrode lead through axillary vein puncture
Subclaivan vein
Lead Placement Through the Subclavian Vein Technique
Device: Placement of electrode lead through subclavian vein puncture

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02358551

Contacts
Contact: Xianlun Li, MD 86-10-84206151 leexianlun@163.com
Contact: Peng Liu, MD, PhD 86-10-84205136 liupengdoc@gmail.com

Locations
China
China-Japan Friendship Hospital Recruiting
Beijing, China, 100029
Contact: Chen Wang, MD    86-10-84205566    zryyyb@126.com   
Sponsors and Collaborators
China-Japan Friendship Hospital
Investigators
Principal Investigator: Xianlun Li, MD China-Japan Friendship Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xianlun Li, Deputy Director, Department of Cardiology, China-Japan Friendship Hospital
ClinicalTrials.gov Identifier: NCT02358551     History of Changes
Other Study ID Numbers: CJFH-2014-086
Study First Received: January 25, 2015
Last Updated: February 3, 2015

Keywords provided by China-Japan Friendship Hospital:
Pacemaker
Axillary Vein
Subclavian vein
Clinical Study
Cardiovascular implantable electronic devices

ClinicalTrials.gov processed this record on April 28, 2017