Plexa ICD Lead Registry

Stopped early

Conditions studied: Implantable Defibrillator User

In brief

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

Key facts

Study ID

NCT03103503

Run by

Biotronik, Inc.

People needed

901

Starts

2017-05-18

Expected to finish

2019-09-27

Last updated by the study team

2020-10-14

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Thomas Hospital Research Office — Fairhope, Alabama, United States
• Jeffrey S Goodman MD — Los Angeles, California, United States
• Eisenhower Desert Cardiology — Rancho Mirage, California, United States
• Florida Hospital — Orlando, Florida, United States
• Advent Health Tampa — Tampa, Florida, United States
• St. Louis Cardiology Consultants — Alton, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Heartland Cardiology — Wichita, Kansas, United States
• Research Integrity LLC — Owensboro, Kentucky, United States
• Northern Light Cardiology — Bangor, Maine, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Metro Health Hospital — Wyoming, Michigan, United States
• Michigan Heart — Ypsilanti, Michigan, United States
• Mercy Clinic Cardiology — Springfield, Missouri, United States
• St. Louis Heart and Vascular — St Louis, Missouri, United States
• Gateway Cardiovascular Research Center — St Louis, Missouri, United States
• Mercy Clinic Heart and Vascular — St Louis, Missouri, United States
• Glacier View Research Institute Cardiology — Kalispell, Montana, United States
• Deborah Heart and Lung Center — Browns Mills, New Jersey, United States
• Novant Health — Winston-Salem, North Carolina, United States
• Sanford Medical Center — Fargo, North Dakota, United States
• The Ohio State Wexner Medical Center — Columbus, Ohio, United States
• Toledo Cardiology — Toledo, Ohio, United States
• The Arrhythmia Institute — Newtown, Pennsylvania, United States
• Upstate Cardiology — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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