Model 4296 Left Ventricular (LV) Lead Chronic Performance Study
Attain Ability® Family Left Ventricular Lead Chronic Performance Study
1 other identifier
observational
1,140
3 countries
99
Brief Summary
Lead survivability will be summarized.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2011
Longer than P75 for all trials
99 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 25, 2011
CompletedFirst Posted
Study publicly available on registry
May 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedJuly 22, 2019
July 1, 2019
8.2 years
May 25, 2011
July 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Model 4296 LV Lead-related complication rate
To demonstrate that the Model 4296 lead-related complication-free probability
5 years
Secondary Outcomes (6)
Types of lead-related adverse device effects
5 years
Percent of subjects with changes in electrode programming
5 years
Number of fractures with and without loss of function
5 years
Bipolar electrical performance at 1 year
1 year
Bipolar pacing impedance
1 year
- +1 more secondary outcomes
Eligibility Criteria
Patients implanted with a 4296 LV Lead within 30 days. All subjects must meet Inclusion criteria and none of the Exclusion criteria.
You may not qualify if:
- Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- Patient has or is intended to receive an Attain Ability Model 4296 LV lead
- Patient within 30 day post implant enrollment window
- Patient who is, or is expected to be inaccessible for follow-up
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtroniclead
Study Sites (99)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Anchorage, Alaska, 99508, United States
Unknown Facility
Chandler, Arizona, 85226, United States
Unknown Facility
Gilbert, Arizona, 85295, United States
Unknown Facility
Phoenix, Arizona, 85006, United States
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Jonesboro, Arkansas, 72410, United States
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Little Rock, Arkansas, 72205, United States
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Bakersfield, California, 93309, United States
Unknown Facility
Chula Vista, California, 91910, United States
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Monterey, California, 93940, United States
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Rancho Mirage, California, 92270, United States
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Redding, California, 96001, United States
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Redwood City, California, 94062, United States
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Salinas, California, 93901, United States
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San Diego, California, 92103, United States
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San Francisco, California, 94143, United States
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Stanford, California, 94305, United States
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Torrance, California, 90503, United States
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Van Nuys, California, 91405, United States
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Colorado Springs, Colorado, 80907, United States
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Lakewood, Colorado, 80228, United States
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New Haven, Connecticut, 06519, United States
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Newark, Delaware, 19713, United States
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Washington D.C., District of Columbia, 20010, United States
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Bradenton, Florida, 34205, United States
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Clearwater, Florida, 33756, United States
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Jacksonville, Florida, 32216, United States
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Melbourne, Florida, 32901, United States
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Safety Harbor, Florida, 34695, United States
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Tampa, Florida, 33607, United States
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Indianapolis, Indiana, 46202, United States
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West Des Moines, Iowa, 50266, United States
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Kansas City, Kansas, 66160, United States
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Lexington, Kentucky, 40503, United States
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Louisville, Kentucky, 40207, United States
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Baton Rouge, Louisiana, 70808, United States
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New Orleans, Louisiana, 70121, United States
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Hyattsville, Maryland, 20782, United States
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Silver Spring, Maryland, 20910, United States
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Takoma Park, Maryland, 20912, United States
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Worcester, Massachusetts, 01605, United States
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Lansing, Michigan, 48912, United States
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Marquette, Michigan, 49855, United States
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Ypsilanti, Michigan, 48197, United States
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Robbinsdale, Minnesota, 55422, United States
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Rochester, Minnesota, 55905, United States
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Saint Louis Park, Minnesota, 55416, United States
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Columbia, Missouri, 65201, United States
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Kansas City, Missouri, 64111, United States
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St Louis, Missouri, 63110, United States
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Henderson, Nevada, 89052, United States
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Las Vegas, Nevada, 89169, United States
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Lebanon, New Hampshire, 03766, United States
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Morristown, New Jersey, 07960, United States
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Ocean City, New Jersey, 07712, United States
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West Orange, New Jersey, 07052, United States
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Albuquerque, New Mexico, 87106, United States
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Garden City, New York, 11530, United States
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Huntington, New York, 11743, United States
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New York, New York, 10016, United States
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Poughkeepsie, New York, 12601, United States
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Utica, New York, 13501, United States
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Durham, North Carolina, 27705, United States
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Greensboro, North Carolina, 27610, United States
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Winston-Salem, North Carolina, 27157, United States
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Fargo, North Dakota, 58122, United States
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Akron, Ohio, 44304, United States
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Cincinnati, Ohio, 45219, United States
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Cleveland, Ohio, 44195, United States
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Toledo, Ohio, 43608, United States
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Allentown, Pennsylvania, 18103, United States
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Danville, Pennsylvania, 17822, United States
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Erie, Pennsylvania, 16550, United States
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Lancaster, Pennsylvania, 17604, United States
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Philadelphia, Pennsylvania, 19104, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Wilkes-Barre, Pennsylvania, 18711, United States
Unknown Facility
Columbia, South Carolina, 29204, United States
Unknown Facility
Germantown, Tennessee, 38138, United States
Unknown Facility
Kingsport, Tennessee, 37660, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
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Austin, Texas, 78705, United States
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Dallas, Texas, 75226, United States
Unknown Facility
Houston, Texas, 77030, United States
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Plano, Texas, 75093, United States
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San Antonio, Texas, 78229, United States
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The Woodlands, Texas, 77384, United States
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Falls Church, Virginia, 22042, United States
Unknown Facility
Leesburg, Virginia, 20176, United States
Unknown Facility
Olympia, Washington, 98506, United States
Unknown Facility
Spokane, Washington, 99204, United States
Unknown Facility
Tacoma, Washington, 98402, United States
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Madison, Wisconsin, 53715, United States
Unknown Facility
Milwaukee, Wisconsin, 53215, United States
Unknown Facility
Ottawa, Ontario, K1Y 4W7, Canada
Unknown Facility
Peterborough, Ontario, K9J 0B2, Canada
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Montreal, Quebec, H2W 1T8, Canada
Unknown Facility
Québec, Quebec, G1V 4G5, Canada
Unknown Facility
Essen, 45147, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2011
First Posted
May 27, 2011
Study Start
May 1, 2011
Primary Completion
July 1, 2019
Study Completion
July 1, 2019
Last Updated
July 22, 2019
Record last verified: 2019-07