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The purpose of this study is to evaluate long-term performance of the 4196 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4196 LV Lead and is integrated within the Product Surveillance Registry (PAN Registry).
Model 4196 LV lead complication-free survivability will be summarized.
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| Measure | Description | Time Frame |
|---|---|---|
| Lead-related complication rate | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Types of lead-related events | 5 years | |
| Percent of subjects with changes in electrode programming | 5 Years | |
| Percent of fractures with loss of function |
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Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.
Inclusion Criteria
Exclusion Criteria
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Patients implanted with a 4196 LV Lead within the past 30 days. All patients must meet Inclusion criteria and none of the Exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| 4196 LV Lead Chronic Performance Study Team | Medtronic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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| 5 years |
| Mean bipolar pacing threshold | 1 year |
| Mean pacing threshold and impedance via Tip and Ring unipolar pacing configurations | 1 year |
| Anchorage |
| Alaska |
| United States |
| Gilbert | Arizona | United States |
| Phoenix | Arizona | United States |
| Scottsdale | Arizona | United States |
| Little Rock | Arkansas | United States |
| Bakersfield | California | United States |
| Chula Vista | California | United States |
| Downey | California | United States |
| East Palo Alto | California | United States |
| Long Beach | California | United States |
| Salinas | California | United States |
| San Bernardino | California | United States |
| Torrance | California | United States |
| Van Nuys | California | United States |
| Colorado Springs | Colorado | United States |
| Denver | Colorado | United States |
| Newark | Delaware | United States |
| Washington D.C. | District of Columbia | United States |
| Bradenton | Florida | United States |
| Clearwater | Florida | United States |
| Jacksonville | Florida | United States |
| Melbourne | Florida | United States |
| Wellington | Florida | United States |
| Atlanta | Georgia | United States |
| Columbus | Georgia | United States |
| Marietta | Georgia | United States |
| Oak Lawn | Illinois | United States |
| Evansville | Indiana | United States |
| Indianapolis | Indiana | United States |
| Des Moines | Iowa | United States |
| Kansas City | Kansas | United States |
| Lexington | Kentucky | United States |
| Louisville | Kentucky | United States |
| Alexandria | Louisiana | United States |
| Baton Rouge | Louisiana | United States |
| Baltimore | Maryland | United States |
| Salisbury | Maryland | United States |
| Silver Spring | Maryland | United States |
| Takoma Park | Maryland | United States |
| Worcester | Massachusetts | United States |
| Grand Blanc | Michigan | United States |
| Marquette | Michigan | United States |
| Saginaw | Michigan | United States |
| Ypsilanti | Michigan | United States |
| Robbinsdale | Minnesota | United States |
| Rochester | Minnesota | United States |
| Columbia | Missouri | United States |
| Kansas City | Missouri | United States |
| Lebanon | New Hampshire | United States |
| Browns Mills | New Jersey | United States |
| Ocean City | New Jersey | United States |
| Parlin | New Jersey | United States |
| West Orange | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| Huntington | New York | United States |
| Utica | New York | United States |
| Durham | North Carolina | United States |
| Greensboro | North Carolina | United States |
| Hickory | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Fargo | North Dakota | United States |
| Akron | Ohio | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Toledo | Ohio | United States |
| Portland | Oregon | United States |
| Erie | Pennsylvania | United States |
| Lancaster | Pennsylvania | United States |
| Sayre | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Columbia | South Carolina | United States |
| Florence | South Carolina | United States |
| Chattanooga | Tennessee | United States |
| Germantown | Tennessee | United States |
| Kingsport | Tennessee | United States |
| Nashville | Tennessee | United States |
| Amarillo | Texas | United States |
| Austin | Texas | United States |
| Dallas | Texas | United States |
| Fort Worth | Texas | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| The Woodlands | Texas | United States |
| Burlington | Vermont | United States |
| Fairfax | Virginia | United States |
| Olympia | Washington | United States |
| Spokane | Washington | United States |
| Madison | Wisconsin | United States |
| Milwaukee | Wisconsin | United States |
| Linz | Austria |
| Hasselt | Belgium |
| Ottawa | Ontario | Canada |
| Ste-Foy | Quebec | Canada |
| Kingston | Canada |
| Toronto | Canada |
| Marseille | France |
| Reggio Emilia | Italy |
| Udine | Italy |
| Eindhoven | Netherlands |
| Rotterdam | Netherlands |
| Valencia | Spain |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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