Status:
COMPLETED
Model 4196 Left Ventricular (LV) Lead Chronic Performance Study
Lead Sponsor:
Medtronic
Conditions:
Heart Failure
Eligibility:
All Genders
Brief Summary
The purpose of this study is to evaluate long-term performance of the 4196 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the numb...
Detailed Description
Model 4196 LV lead complication-free survivability will be summarized.
Eligibility Criteria
Inclusion
- 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
- 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 4196 LV lead
- Patient within 30 day post implant enrollment window
- Exclusion Criteria
- Patient who is, or is expected to be inaccessible for follow-up
- Patient with exclusion criteria required by local law
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
1847 Patients enrolled
Trial Details
Trial ID
NCT00930904
Start Date
June 1 2009
End Date
April 1 2017
Last Update
December 27 2017
Active Locations (103)
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1
Birmingham, Alabama, United States
2
Anchorage, Alaska, United States
3
Gilbert, Arizona, United States
4
Phoenix, Arizona, United States