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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left Ventricular Capture Management Software | Device |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the accuracy of left ventricular capture management (LVCM) |
| Measure | Description | Time Frame |
|---|---|---|
| To compare left ventricular capture management (LVCM) measurements to a similar measurement taken automatically when subjects are completing normal daily activities | ||
| To evaluate subject rhythm and rate immediately following an LVCM measurements |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
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| To characterize all adverse events |
| Little Rock |
| Arkansas |
| United States |
| Palo Alto | California | United States |
| Bridgeport | Connecticut | United States |
| Atlantis | Florida | United States |
| Ormond Beach | Florida | United States |
| Oak Lawn | Illinois | United States |
| Indianapolis | Indiana | United States |
| Portland | Maine | United States |
| Minneapolis | Minnesota | United States |
| Kansas City | Missouri | United States |
| West Orange | New Jersey | United States |
| Charlotte | North Carolina | United States |
| Wynnewood | Pennsylvania | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Richmond | Virginia | United States |
| Morgantown | West Virginia | United States |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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