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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Mechanical Complication of Cardiac Pacemaker

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Axillary vein

Lead Placement Through the Axillary Vein Technique

Group Type OTHER

Placement of electrode lead through axillary vein puncture

Intervention Type DEVICE

Subclaivan vein

Lead Placement Through the Subclavian Vein Technique

Group Type OTHER

Placement of electrode lead through subclavian vein puncture

Intervention Type DEVICE

Interventions

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Placement of electrode lead through axillary vein puncture

Intervention Type DEVICE

Placement of electrode lead through subclavian vein puncture

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No