Status:
COMPLETED
Attain StarFix® 4195 Lead Extraction Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
Indications for Lead Removal
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to characterize the removability of the Attain StarFix® Model 4195 Left Ventricular (LV) Lead (StarFix®). The goal of the trial is to evaluate the lead removal success in ...
Eligibility Criteria
Inclusion
- Subjects with a Class I/II indication and/or physician discretion for left ventricular lead removal
- 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
- None
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT00893386
Start Date
July 1 2009
End Date
April 1 2015
Last Update
February 1 2016
Active Locations (24)
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1
Phoenix, Arizona, United States
2
Burbank, California, United States
3
Long Beach, California, United States
4
Aurora, Colorado, United States