Mechanical Complication of Cardiac Pacemaker
Conditions
Keywords
Pacemaker, Axillary Vein, Subclavian vein, Clinical Study, Cardiovascular implantable electronic devices
Brief 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.
Interventions
DEVICEPlacement of electrode lead through axillary vein puncture
DEVICEPlacement of electrode lead through subclavian vein puncture
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of vein puncture | 1 Day |
Secondary
| Measure | 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 |
Countries
China
Contacts
Primary ContactXianlun Li, MD
Backup ContactPeng Liu, MD, PhD
Outcome results
None listed