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Sponsored by: |
Medtronic Cardiac Rhythm Disease Management |
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Information provided by: | Medtronic Cardiac Rhythm Disease Management |
ClinicalTrials.gov Identifier: | NCT00269230 |
People who have abnormal heart beats, or whose heart does not beat on its own, may need an electronic device called a pacemaker or a defibrillator.
Furthermore, people whose hearts have a reduced pumping ability may need a device are called cardiac resynchronization therapy (CRT) device. A CRT device is implanted surgically just under the skin in the upper chest area. This device then helps the heart beat at a regular rhythm by sending electrical signals (pacing) directly to the heart tissue through flexible wires called leads. The device may also be able to stop the heart from beating too fast. Three leads are implanted into the chambers of your heart. Two of the leads will be placed on the right side of your heart. The third lead is placed on the left side of your heart and is the lead being studied.
The purpose of this study is to evaluate the safety and efficacy of the Attain StarFixTM Model 4195 Left Ventricular (LV) Lead. This particular model lead has special characteristics that may help to better keep it in position once it is implanted into the left ventricle. It is also "steroid-eluting" which means that over time it slowly releases a small amount of medication into the heart tissue to help prevent too much swelling around the area it is implanted.
Condition | Intervention |
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Heart Failure |
Device: Pacing Lead |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Attain StarFix™ Model 4195 Left Ventricular Lead |
Enrollment: | 441 |
Study Start Date: | July 2004 |
Study Completion Date: | July 2005 |
Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Stuart W Adler II, MD | St. Paul Heart Clinic |
Responsible Party: | Medtronic CRDM ( CRDM Core Clinical ) |
Study ID Numbers: | 234 |
Study First Received: | December 21, 2005 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00269230 History of Changes |
Health Authority: | United States: Food and Drug Administration |
cardiac resynchronization therapy, left ventricular Lead, Heart Failure |
Heart Failure Heart Diseases |
Heart Failure Heart Diseases Cardiovascular Diseases |