Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
227 participants
OBSERVATIONAL
2009-07-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Non-4195 Lead, 181 days
Patients with a Medtronic LV Lead, other than Model 4195, implanted at least 181 days
LV Lead Extraction
Removal of a LV lead using any tools \& techniques.
4195 Lead, 181 days
Patients with a Medtronic Model 4195 LV Lead implanted at least 181 days
LV Lead Extraction
Removal of a LV lead using any tools \& techniques.
4195 Lead, 90-180 days
Patients with Medtronic Model 4195 LV Lead implanted for 90-180 days
LV Lead Extraction
Removal of a LV lead using any tools \& techniques.
Interventions
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LV Lead Extraction
Removal of a LV lead using any tools \& techniques.
Eligibility Criteria
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Inclusion Criteria
* Medtronic Model 4195 LV lead implanted for at least 181 days at time of extraction, or other Medtronic LV Lead (non-Model 4195) implanted for at least 181 days at time of extraction, or Medtronic Model 4195 LV lead implanted for 90-180 days
* Intention to remove the LV lead prior to the extraction procedure
* Subject is 18 years of age or older
* Subject (or subject's legally authorized representative) has signed and dated the Patient Consent Form and is willing and able to comply with the protocol
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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4195 Extraction Study Team
Role: STUDY_CHAIR
Medtronic
Locations
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Phoenix, Arizona, United States
Burbank, California, United States
Long Beach, California, United States
Aurora, Colorado, United States
Miami, Florida, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Saint Paul, Minnesota, United States
St Louis, Missouri, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
Spokane, Washington, United States
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Sainte-Foy, Quebec, Canada
Countries
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Other Identifiers
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StarFix Extraction
Identifier Type: -
Identifier Source: org_study_id
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