Status:
TERMINATED
Protego DF4 Post Approval Registry
Lead Sponsor:
Biotronik, Inc.
Conditions:
Implantable Defibrillator User
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this registry study is to confirm the long-term safety and reliability of the Protego DF4 right ventricular lead.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 27 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 17 2019
Estimated Enrollment :
1694 Patients enrolled
Trial Details
Trial ID
NCT02243696
Start Date
September 27 2014
End Date
April 17 2019
Last Update
June 22 2020
Active Locations (68)
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1
Gadsden, Alabama, United States
2
Avondale, Arizona, United States
3
Glendale, Arizona, United States
4
Peoria, Arizona, United States