Clinical Investigation of the SelectSecure Pacing Lead

Completed · Not applicable

Conditions studied: Bradycardia

In brief

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.

Key facts

Study ID

NCT00266682

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

365

Starts

2002-08-01

Expected to finish

2005-08-01

Last updated by the study team

2006-10-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who are in need of a pacemaker that paces in both the right atrium and ventricle.

You may not qualify if…

• Subjects who are in need of an implantable cardioverter defibrillator (ICD).
• Subjects who have a mechanical or diseased tricuspid valve (a structure in the heart, located between the right atrium and right ventricle, which allows blood to flow from the atrium to the ventricle).
• Steroid contraindication

Where it is running

• Study site — Anchorage, Alaska, United States
• Study site — Peoria, Arizona, United States
• Study site — Long Beach, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Evanston, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Des Moines, Iowa, United States
• Study site — Iowa City, Iowa, United States
• Study site — Kansas City, Kansas, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Robbinsdale, Minnesota, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Kansas City, Missouri, United States
• Study site — Springfield, Missouri, United States
• Study site — Livingston, New Jersey, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Lancaster, Pennsylvania, United States
• Study site — Sayre, Pennsylvania, United States
• Study site — Germantown, Tennessee, United States
• Study site — Nashville, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Temple, Texas, United States

Full record on ClinicalTrials.gov

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