Attain Performa™ Left Ventricular (LV) Quadripolar Leads Chronic Performance Study
Study Details
Study Description
Brief Summary
Lead survivability will be summarized.
Condition or Disease | Intervention/Treatment | Phase |
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|
Detailed Description
The purpose of this study is to evaluate long-term performance of the Attain Performa™ LV Leads. 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 Attain Performa™ LV Leads. This study is conducted within Medtronic's post-market surveillance platform.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Attain Performa™ LV Leads Patients who meet all Inclusion criteria and no Exclusion criteria and are implanted with an Attain Performa™ LV lead. |
Outcome Measures
Primary Outcome Measures
- Lead complication [5 years]
Survival analysis will be used to analyze the lead. Lead status will be reported as a function of time post-implant for all leads in the study. Lead related complications include but are not limited to: failure to capture, abnormal sensing, threshold rise, abnormal impedance, insulation breach, conductor fracture, extracardiac stimulation, lead dislodgement, cardiac perforation, structural lead failure.
Secondary Outcome Measures
- Types of lead-related adverse device effects [5 years]
Summary statistics will be used to report types and rates of lead related adverse device effects (ADE). Examples of ADEs include but are not limited to: failure to capture, abnormal sensing, threshold rise, abnormal impedance, insulation breach, conductor fracture, extracardiac stimulation, lead dislodgement, cardiac perforation, structural lead failure.
- Returned lead analysis [5 years]
A listing of analysis results of all Attain Performa study leads which are explanted and returned for analysis will be reported.
- Lead survival estimate by model [5 years]
An analysis will be conducted at the end of the study to provide comparative statistics on the safety performance of each individual lead model.
Eligibility Criteria
Criteria
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
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Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
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Patient has or is intended to receive an Attain Performa™ LV lead
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Patient within 30 day post implant enrollment window
Exclusion Criteria
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Patient who is, or is expected to be inaccessible for follow-up
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Patient with exclusion criteria required by local law
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Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Birmingham | Alabama | United States | 35294 | |
2 | Anchorage | Alaska | United States | 99508 | |
3 | Chandler | Arizona | United States | 85226 | |
4 | Gilbert | Arizona | United States | 85295 | |
5 | Jonesboro | Arkansas | United States | 72410 | |
6 | Bakersfield | California | United States | 93301 | |
7 | Rancho Mirage | California | United States | 92270 | |
8 | Redwood City | California | United States | 94062 | |
9 | Salinas | California | United States | 93901 | |
10 | San Diego | California | United States | 92103 | |
11 | Stanford | California | United States | 94305 | |
12 | Torrance | California | United States | 90503 | |
13 | Van Nuys | California | United States | 91405 | |
14 | Colorado Springs | Colorado | United States | 80907 | |
15 | Lakewood | Colorado | United States | 80228 | |
16 | New Haven | Connecticut | United States | 06519 | |
17 | Washington | District of Columbia | United States | 20010 | |
18 | Bradenton | Florida | United States | 34205 | |
19 | Clearwater | Florida | United States | 33756 | |
20 | Jacksonville | Florida | United States | 32216 | |
21 | Safety Harbor | Florida | United States | 34695 | |
22 | Albany | Georgia | United States | 31701 | |
23 | Marietta | Georgia | United States | 30060 | |
24 | Evansville | Indiana | United States | 47710 | |
25 | West Des Moines | Iowa | United States | 50266 | |
26 | Kansas City | Kansas | United States | 66160 | |
27 | Edgewood | Kentucky | United States | 41017 | |
28 | Lexington | Kentucky | United States | 40503 | |
29 | Louisville | Kentucky | United States | 40207 | |
30 | Baton Rouge | Louisiana | United States | 70808 | |
31 | Hyattsville | Maryland | United States | 20782 | |
32 | Salisbury | Maryland | United States | 21804 | |
33 | Silver Spring | Maryland | United States | 20910 | |
34 | Takoma Park | Maryland | United States | 20912 | |
35 | Lansing | Michigan | United States | 48912 | |
36 | Marquette | Michigan | United States | 49855 | |
37 | Ypsilanti | Michigan | United States | 48197 | |
38 | Minneapolis | Minnesota | United States | 55407 | |
39 | Robbinsdale | Minnesota | United States | 55422 | |
40 | Rochester | Minnesota | United States | 554905 | |
41 | Hattiesburg Clinic | Hattiesburg | Mississippi | United States | |
42 | Columbia | Missouri | United States | 65201 | |
43 | Kansas City | Missouri | United States | 64111 | |
44 | Saint Louis | Missouri | United States | 63110 | |
45 | Las Vegas | Nevada | United States | 89169 | |
46 | Lebanon | New Hampshire | United States | 03766 | |
47 | Morristown | New Jersey | United States | 07960 | |
48 | Albuquerque | New Mexico | United States | 87106 | |
49 | Huntington | New York | United States | 11743 | |
50 | New York | New York | United States | 10032 | |
51 | Poughkeepsie | New York | United States | 12601 | |
52 | Utica | New York | United States | 13501 | |
53 | Charlotte | North Carolina | United States | 28203 | |
54 | Durham | North Carolina | United States | 27705 | |
55 | Raleigh | North Carolina | United States | 27610 | |
56 | Akron | Ohio | United States | 44304 | |
57 | Cincinnati | Ohio | United States | 45219 | |
58 | Cleveland | Ohio | United States | 44195 | |
59 | Toledo | Ohio | United States | 43608 | |
60 | Portland | Oregon | United States | 97220 | |
61 | Allentown | Pennsylvania | United States | 18103 | |
62 | St Luke's University Health Network | Bethlehem | Pennsylvania | United States | |
63 | Danville | Pennsylvania | United States | 17822 | |
64 | Erie | Pennsylvania | United States | 16550 | |
65 | Philadelphia | Pennsylvania | United States | 19104 | |
66 | Pittsburgh | Pennsylvania | United States | 15213 | |
67 | Wilkes-Barre | Pennsylvania | United States | 18711 | |
68 | Germantown | Tennessee | United States | 38138 | |
69 | Nashville | Tennessee | United States | 37203 | |
70 | Austin | Texas | United States | 78705 | |
71 | Dallas | Texas | United States | 75226 | |
72 | Fort Worth | Texas | United States | 76104 | |
73 | Houston | Texas | United States | 77030 | |
74 | Plano | Texas | United States | 75093 | |
75 | The Woodlands | Texas | United States | 77384 | |
76 | Burlington | Vermont | United States | 05401 | |
77 | Falls Church | Virginia | United States | 22042 | |
78 | Leesburg | Virginia | United States | 20176 | |
79 | Spokane | Washington | United States | 99204 | |
80 | Madison | Wisconsin | United States | 53715 | |
81 | Milwaukee | Wisconsin | United States | 53215 | |
82 | Leuven | Belgium | |||
83 | Calgary | Alberta | Canada | ||
84 | London | Ontario | Canada | ||
85 | Montreal | Quebec | Canada | ||
86 | Calgary | Canada | |||
87 | Ottawa | Canada | |||
88 | Quebec | Canada | |||
89 | La Rochelle | France | |||
90 | Nantes | France | |||
91 | Essen | Germany | |||
92 | Hannover | Germany | |||
93 | Ulm | Germany | |||
94 | Eindhoven | Netherlands | |||
95 | Maastricht | Netherlands | |||
96 | Nieuwegein | Netherlands | |||
97 | Rotterdam | Netherlands | |||
98 | Zurich | Switzerland | |||
99 | Liverpool | United Kingdom | |||
100 | Middlesbrough | United Kingdom |
Sponsors and Collaborators
- Medtronic
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Attain Performa™ PAS