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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: | NCT00268281 |
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed.
Left Ventricular Capture Management (LVCM) refers to the overall method for determining left ventricular thresholds (level of energy needed to effectively pace the tissue in the lower left chamber of the heart) by measuring, analyzing, and adjusting energy delivered from the CRT device to the pacing lead.
The purpose of the Left Ventricular Capture Management Software Download Clinical Trial was to evaluate the accuracy of the Left Ventricular Capture Management (LVCM) feature to support LVCM feature approval in future cardiac resynchronization therapy with defibrillation (CRT-D) devices
Condition | Intervention |
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Heart Failure |
Device: Left Ventricular Capture Management Software |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Left Ventricular Capture Management (LVCM) Software Download Clinical Trial |
Estimated Enrollment: | 107 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | July 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 238 |
Study First Received: | December 21, 2005 |
Last Updated: | October 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00268281 History of Changes |
Health Authority: | United States: Food and Drug Administration |
cardiac resynchronization therapy |
Heart Failure Heart Diseases |
Heart Failure Heart Diseases Cardiovascular Diseases |