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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacing Lead | Device | Left ventricular pacing lead |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Efficacy at 3 months | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Implant success rate and times with the Model 4195; Handling characteristics and electrical performance of the Model 4195; All adverse events occurring throughout study | Ongoing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart W Adler II, MD | St. Paul Heart Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach | California | United States | ||||
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| Palo Alto |
| California |
| United States |
| Newark | Delaware | United States |
| Jacksonville | Florida | United States |
| Orlando | Florida | United States |
| Atlanta | Georgia | United States |
| Lexington | Kentucky | United States |
| Grand Rapids | Michigan | United States |
| Saginaw | Michigan | United States |
| Saint Paul | Minnesota | United States |
| St Louis | Missouri | United States |
| Lincoln | Nebraska | United States |
| Newark | New Jersey | United States |
| Rochester | New York | United States |
| Durham | North Carolina | United States |
| Germantown | Tennessee | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Temple | Texas | United States |
| Milwaukee | Wisconsin | United States |
| Calgary | Alberta | Canada |
| Victoria | British Columbia | Canada |
| London | Ontario | Canada |
| Sainte-Foy | Quebec | Canada |
| Milan | Italy |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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