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

Imagem
Tachycardia Therapy

Tachycardia Therapy

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