Protego DF4 Post Approval Registry

  • Observational [Patient Registry]
  • Recruiting
  • NCT02243696
Eligibility Details Visit Clinicaltrials.gov

Protego DF4 Post Approval Registry

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

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT02243696

IRB#IRB14-1238

Lead SponsorBiotronik, Inc.

Lead PhysicianRoderick Tung

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting