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Clinical Trials

Topic   Cardiology
Title   PROTEGO DF4 Registry
Summary   This is a registry, that is an observational study, without any treatment or intervention, that follows patients who have had a certain type of implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) placed. The purpose of this study is to confirm the long-term safety and reliability of BIOTRONIK’s Protego DF4 lead (a wire that delivers energy to the heart muscle).
Description   Patients who have had a successful implant with a BIOTRONIK IIesto DF4 ICD or CRT-D or future market released BIOTRONIK DF4 ICD or CRT-D can be enrolled in this observational registry up to 30 days before or 30 days after implant with DF4 system. There will be a total of 1,694 subjects enrolled and data collection will continue for five years after implant for each patient. The researchers will evaluate the overall incidence of adverse events that are related to the Protego lead or device. They will also look at other device measurements such as pacing, threshold, sensing, and impedance for five years after implant. There is no research study treatment or intervention for patients who are enrolled in this study, meaning that their care is not changed by being enrolled in this study. Patients are simply followed over time, and data is collected. The purpose of this study is to confirm the long-term safety and reliability of BIOTRONIK’s Protego DF4 lead (wire that delivers energy to the heart muscle).
IRB Number   # 15312
Inclusion/Notes   Patients who have had a successful implant with a BIOTRONIK IIesto DF4 ICD or CRT-D or future market released BIOTRONIK DF4 ICD or CRT-D can be enrolled in this observational registry up to 30 days before or 30 days after implant with DF4 system.
Principal Name   Joseph Germano, DO
Contact Name   Wendy Drewes, BSN, RN, CCRC, Dipti Patel, MSN, MPH
Email   jgermano@nyuwinthrop.org
Phone   516-663-2929
Alternate Phone   516-663-8692