Plexa ICD Lead Registry

Biotronik

Status: Terminated

Conditions: Implantable Defibrillator User

Study type: Observational

Funder types: Industry

Identifiers

NCT03103503

Plexa Registry

Details and patient eligibility

About

The purpose of this registry is to confirm the long-term safety and reliability of BIOTRONIK's Plexa ICD lead.

Enrollment: 901 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Successfully implanted with a BIOTRONIK ICD or CRT-D compatible system along with the Plexa lead no more than 30 days prior to consent
• Able to understand the nature of the registry and provide informed consent
• Available for follow-up visits on a regular basis at the study site for the expected 5 years of follow-up
• Accepts BIOTRONIK Home Monitoring® concept
• Age greater than or equal to 18 years

Exclusion criteria

• Enrolled in any investigational cardiac device trial
• Enrolled in BIOTRONIK's QP ExCELs lead study
• 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
• Patients reporting pregnancy at the time of enrollment

Trial design