Protego

Protego

Protego DF4 Post-Approval Registry

Study Design

Prospective, single-arm, non-randomized, multi-center registry
Designed to confirm long-term safety and reliability of BIOTRONIK's Protego DF4 lead, as used in conjunction with a BIOTRONIK DF4 compatible implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) pulse generator
1,694 patients with an ICD or CRT-D implant at up to 75 centers in USA - This study is ongoing

Study Objective	Evaluate the long-term safety and reliability of the Protego DF4 lead
1° Endpoints	Evaluation of the overall incidence of adverse events (AEs) related to the Protego lead or device header Evaluation of the incidence of each individual type of AE that contributes to Primary Endpoint 1
2° Endpoints	Pacing threshold, sensing and impedance measurements for the Protego lead through 5 years post-implant Shock impedance for the Protego lead through 5 years post-implant AE rates for AEs excluded from primary safety endpoints 1 and 2, through 5 years post-implant
Clinical Sites	Up to 75 sites in USA
Sample Size	1,694 patients
Inclusion Criteria	Implanted within the last 30 days or candidate for implantation of 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
Main Exclusion Criteria	Enrolled in any investigational cardiac device trial Planned cardiac surgical procedure 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
Devices	All BIOTRONIK DF4 compatible ICD or CRT-D devices, including Ilesto VR-T DF4, Ilesto DR-T DF4, Ilesto HF-T DF4, Itrevia VR-T DF4, Itrevia DR-T DF4, Itrevia HF-T DF4, Itrevia HF-T QP, and Iperia 7 DR-T DF4 All right ventricular leads must be the Protego DF4 lead Manufacturer of right atrial and left ventricular leads are left to the discretion of the implanting physician
Follow-Up	5 years from implantation; 3-months post implant, 6-months post implant, and every 6 months thereafter; Home Monitoring may be used up to every other study visit beginning with the 3-month visit
Study Duration	Study start date September 2014. Estimated study completion June 2024
Reference no.	NCT02243696

Tachycardia Therapy

Tachycardia Therapy

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BIOTRONIK offers an extensive product portfolio in the area of tachycardia therapy.