Clinical Investigation of the SelectSecure Pacing Lead

Status Completed

Clinical Trial Summary

People who have a slow heart beat, or whose heart does not beat on its own, may be in need of an electronic device called a pacemaker. A pacemaker is implanted surgically just under the skin in the upper chest area. This device helps the heart beat at a regular rhythm by sending electrical signals (pacing) directly to the heart tissue through flexible wires called leads. The purpose of this study is to demonstrate that the SelectSecure (Model 3830) lead is safe and effective for both sensing the heart’s natural rhythm and pacing the heart when it does not beat on its own. This lead will be studied in both the right atrium and right ventricle. A previously market approved Medtronic lead model will serve as a comparison to prove the safety and effectiveness of the SelectSecure Model.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Bradycardia

Clinical Trial Details

NCT number	NCT00266682
Study type	Interventional
Source	Medtronic Cardiac Rhythm Disease Management
Contact
Status	Completed
Phase	N/A
Start date	August 2002
Completion date	August 2005

View Details

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