Model 4195 Left Ventricular (LV) Lead Chronic Performance Study
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/15/2018 |
| Start Date: | March 2009 |
| End Date: | April 3, 2018 |
Attain StarFix® Model 4195 Left Ventricular Lead Chronic Performance Post Approval Study
Evaluate long-term performance of the 4195 LV Lead. This evaluation is based on the number of
lead-related complications occuring 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 Model 4195 LV Lead and is integrated within Medtronic's
post-market surveillance platform.
lead-related complications occuring 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 Model 4195 LV Lead and is integrated within Medtronic's
post-market surveillance platform.
Model 4195 LV lead complication-free survivability will be summarized.
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 StarFix Model 4195 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
We found this trial at
63
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials