Clinical Trial: Clinical Investigation of the SelectSecure Pacing Lead

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Investigation of the SelectSecure Pacing Lead

Brief 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.

Detailed Summary:
Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Current Primary Outcome: 3-month safety (complications and all lead-related adverse events) and efficacy ( pacing and sensing) objectives

Original Primary Outcome: Same as current

Current Secondary Outcome: Lead and catheter handling characteristics, and lead impedance

Original Secondary Outcome: Same as current

Information By: Medtronic Cardiac Rhythm and Heart Failure

Dates:
Date Received: December 16, 2005
Date Started: August 2002
Date Completion: August 2005
Last Updated: October 11, 2006
Last Verified: October 2006