Protego DF4 Post Approval Registry

Biotronik

Status: Terminated

Conditions: Implantable Defibrillator User

Study type: Observational

Funder types: Industry

Identifiers

NCT02243696

P980023/S057

Details and patient eligibility

About

The purpose of this registry study is to confirm the long-term safety and reliability of the Protego DF4 right ventricular lead.

Enrollment: 1,694 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design