Protego DF4 Post Approval Registry
Status: | Active, not recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/7/2019 |
Start Date: | September 2014 |
End Date: | October 2021 |
The purpose of this registry study is to confirm the long-term safety and reliability of the
Protego DF4 right ventricular lead.
Protego DF4 right ventricular lead.
Inclusion Criteria:
- Implanted within the last 30 days or candidate for implantation of a BIOTRONIK ICD or
CRT-D DF4 compatible system along with the Protego DF4 lead
- Meets ICD or CRT-D system implant recommendations as defined in guidelines published
by relevant professional societies
- Able to understand the nature of the registry and provide informed consent
- Available for follow-up visits on a regular basis at the investigational site for the
expected 5 years of follow-up
- Age greater than or equal to 18 years
Exclusion Criteria:
- Enrolled in any investigational cardiac device trial
- Planned cardiac surgical procedures or interventional measures within the next 6
months
- Expected to receive heart transplantation or ventricular assist device within 1 year
- Life expectancy of less than 1 year
- Presence of another life-threatening, underlying illness separate from their cardiac
disorder
- Patients reporting pregnancy at the time of enrollment
We found this trial at
68
sites
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