An observational study in Heart Failure, sponsored by Medtronic. Completed at 52 sites in 3 countries. Per ClinicalTrials.gov, last updated 2021-02-17.
Sponsored by Medtronic · Observational
Lead survivability will be summarized.
The purpose of this study is to evaluate long-term performance of the 4396 LV Lead. This evaluation is based on the number of lead-related complications occurring 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 4396 LV Lead. This study is conducted within Medtronic's post-market surveillance platform.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 366 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Medtronic is the lead sponsor of 42 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients implanted with a 4396 LV Lead within 30 days. All subjects must meet Inclusion criteria and none of the Exclusion criteria.
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
Exclusion Criteria
Model 4396 LV Lead-related complication rate
Time frame: 5 years
Types of lead-related adverse device effects
Time frame: 5 years
Percent of subjects with changes in electrode programming
Time frame: 5 years
Number of fractures with and without loss of function
Time frame: 5 years
Bipolar electrical performance at 1 year
Time frame: 1 year
Bipolar pacing impedance
Time frame: 1 year
Bipolar pacing capture threshold
Time frame: 1 year
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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