Protego DF4 Post Approval Registry

Stopped early

Conditions studied: Implantable Defibrillator User

In brief

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

Key facts

Study ID

NCT02243696

Run by

Biotronik, Inc.

People needed

1694

Starts

2014-09-27

Expected to finish

2019-04-17

Last updated by the study team

2020-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Avondale, Arizona, United States
• Study site — Glendale, Arizona, United States
• Study site — Peoria, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Escondido, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Hawthorne, California, United States
• Study site — Los Angeles, California, United States
• Study site — Santa Barbara, California, United States
• Study site — Temecula, California, United States
• Study site — Torrance, California, United States
• Study site — Norwalk, Connecticut, United States
• Study site — Brooksville, Florida, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Miami, Florida, United States
• Study site — New Smyrna Beach, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Zephyrhills, Florida, United States
• Study site — Alton, Illinois, United States
• Study site — Aurora, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Gadsden, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.