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Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted within Medtronic's System Longevity Study (SLS).
As part of the requirement to satisfy the PMA Conditions of Approval for the Medtronic Model 4965 CapSure Epi® Steroid-Eluting Unipolar Epicardial Pacing Lead, 50 adult subjects who were ≥19 years old at time of implant were followed for one-year post-implant.
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| Measure | Description | Time Frame |
|---|---|---|
| Model 4965 Complication Free Rate | A 4965 lead-related complication is an adverse event requiring invasive intervention to resolve. The complication-free rate is based on the number of leads analyzed. | 1 year |
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Inclusion Criteria:
AND one of the following (A, B, or C) must also apply:
A. Subjects indicated for implant or within six months post-implant of a Medtronic market-released lead connected to a market-released IPG, ICD, or CRT Device. The Medtronic lead must be used for a pacing, sensing, or defibrillation application.
B. Subjects who participated in a qualifying study of a Medtronic cardiac therapy product and for whom:
Note: Subjects currently active in the Chronic Lead Study or Tachyarrhythmia Chronic Systems Study will continue in the follow-up phase of the SLS.
Exclusion Criteria:
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Subjects 19 years or older implanted with Model 4965 Capsure Epi Lead.
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| Name | Affiliation | Role |
|---|---|---|
| 4965 Post-Approval Study Clinical Trial Leader | Medtronic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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The study utilized centers that had implanted model 4965 leads in adult subjects to obtain information regarding safety, lead events, and lead survival.
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| ID | Title | Description |
|---|---|---|
| FG000 | Medtronic 4965 Subjects | Single arm registry of Model 4965 implanted patients |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Anchorage |
| Alaska |
| 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 |
| Los Angeles | California | United States |
| Salinas | California | United States |
| Torrance | California | United States |
| Van Nuys | California | United States |
| Colorado Springs | Colorado | United States |
| Denver | Colorado | United States |
| Washington D.C. | District of Columbia | United States |
| Clearwater | Florida | United States |
| Jacksonville | Florida | United States |
| Melbourne | Florida | United States |
| Ocala | Florida | United States |
| Wellington | Florida | United States |
| Atlanta | Georgia | United States |
| Columbus | Georgia | United States |
| Marietta | Georgia | United States |
| Oak Lawn | Illinois | United States |
| Indianapolis | Indiana | United States |
| Newburgh | 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 |
| Salisbury | Maryland | United States |
| Silver Spring | Maryland | United States |
| Towson | Maryland | United States |
| Grand Blanc | Michigan | United States |
| Marquette | Michigan | United States |
| Saginaw | Michigan | United States |
| Southfield | Michigan | United States |
| Robbinsdale | Minnesota | United States |
| Rochester | Minnesota | United States |
| Saint Paul | Minnesota | United States |
| Kansas City | Missouri | United States |
| Lebanon | New Hampshire | United States |
| Browns Mills | New Jersey | United States |
| Newark | 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 |
| Mineola | New York | United States |
| Rochester | New York | United States |
| Greensboro | North Carolina | United States |
| Hickory | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Toledo | Ohio | United States |
| Portland | Oregon | United States |
| Doylestown | Pennsylvania | United States |
| Lancaster | Pennsylvania | United States |
| Sayre | Pennsylvania | United States |
| Columbia | South Carolina | United States |
| Florence | South Carolina | United States |
| Sioux Falls | South Dakota | United States |
| Chattanooga | Tennessee | United States |
| Germantown | Tennessee | United States |
| Memphis | 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 |
| Chesapeake | Virginia | United States |
| Fairfax | Virginia | United States |
| Olympia | Washington | United States |
| Spokane | Washington | United States |
| Madison | Wisconsin | United States |
| Milwaukee | Wisconsin | United States |
| Bedford Park | South Australia | Australia |
| Linz | Austria |
| Vienna | Austria |
| Hasselt | Belgium |
| Calgary | Alberta | Canada |
| Hamilton | Ontario | Canada |
| Ottawa | Ontario | Canada |
| Toronto | Ontario | Canada |
| Montreal | Quebec | Canada |
| Ste-Foy | Quebec | Canada |
| Regina | Saskatchewan | Canada |
| Copenhagen | Denmark |
| Marseille | France |
| Homburg/Saar | Germany |
| Catanzaro | Italy |
| Reggio Emilia | Italy |
| Udine | Italy |
| Eindhoven | Netherlands |
| Rotterdam | Netherlands |
| Belgrade | Serbia |
| Valencia | Spain |
| Skövde | Sweden |
| Zurich | Switzerland |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Medtronic 4965 Subjects | Single arm registry of Model 4965 implanted patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Model 4965 Complication Free Rate | A 4965 lead-related complication is an adverse event requiring invasive intervention to resolve. The complication-free rate is based on the number of leads analyzed. | Patients ≥ 19 yrs at implant of MDT 4965 Epicardial Lead. | Posted | Number | 95% Confidence Interval | Model 4965 complication free rate | 1 year | 4965 leads | 4965 leads |
|
|
|
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For this study, "serious" is defined as requiring an invasive intervention to resolve.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Medtronic 4965 Subjects | Single arm registry of Model 4965 implanted patients | 2 | 73 | 0 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Failure to capture | Vascular disorders | Systematic Assessment | Intermittent |
| |
| Lead conductor fracture | Vascular disorders | Systematic Assessment | Lead electrically abandoned |
|
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The study cohort was limited to subjects >19 years of age at the time of implant, limiting the survival analysis of the Model 4965 lead in a pediatric population.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stefanie Lorinser, Sr. Clinical Research Specialist | Medtronic, Inc. | 763-526-2742 | stefanie.lorinser@medtronic.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001919 | Bradycardia |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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