NCT00266682

Clinical Investigation of the SelectSecure Pacing Lead

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 365 (planned)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 0 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bradycardia

Interventions

Type	Name	Description
DEVICE	Pacing Lead

Timeline

• Start date: 2002-08-01
• Completion: 2005-08-01
• First posted: 2005-12-19
• Last updated: 2006-10-13

Locations

31 sites across 3 countries: United States, Australia, Canada