QP ExCELs

QP ExCELs

Sentus QP - Extended CRT Evaluation with Quadripolar Left Ventricular Leads

NCT02290028

Study Design

  • Prospective, non-randomized, multi-center study
  • Confirm the safety and efficacy of BIOTRONIK’s Sentus QP leads in a clinical investigation to support regulatory approval as well as a long-term post-approval evaluation of the devices in the United States.
  • Pre-market: Up to 314 subjects at up to 75 sites within the United States and up to 125 sites worldwide Post-approval: Up to 1,754 subjects enrolled at up to 75 sites within the United States
  • This study is currently recruiting participants.

Reference no.
  • NCT02290028
Study Objective
  • Pre-market:
  • Confirm the safety and effectiveness of the BIOTRONIK Sentus OTW QP left ventricular pacing leads
  • Post-approval:
  • Confirm long-term safety of the BIOTRONIK Sentus OTW QP left ventricular pacing leads
1° Endpoints
  • Sentus QP related complication-free rate through 6 months
  • Percentage of subjects with acceptable pacing threshold of Sentus QP lead in permanently programmed vector at 3 months
  • Sentus QP related complication-free rate through 5 years post-implant
2° Endpoints
  • Sentus QP pacing threshold in permanently programmed vector at 3 months per lead model
  • Sentus QP pacing threshold in novel vectors at 3 months
  • Sentus QP R-wave sensed amplitude at 3 months per lead model
  • Sentus QP pacing impedance at 3 months per lead model
  • Sentus QP time to first complication
  • Percentage of subjects successfully reprogrammed to resolve phrenic nerve stimulation or high LV pacing threshold during the study period
  • Sentus QP related complication-free rate through 5 years post-implant per lead model
  • Sentus QP Lead Safety – Individual 5-year adverse event rates
Clinical Sites
  • Pre-market:
  • Up to 75 sites (US), up to 125 sites (worldwide)
  • Post-approval:
  • Up to 75 sites (US)
Sample Size
  • Pre-market:
  • Up to 314 subjects
  • Post-approval:
  • Up to 1754 subjects
Inclusion Criteria
  • Standard CRT-D indication according to clinical routine
  • De novo implantation or upgrade from existing ICD or pacemaker implant (with no prior attempt at LV lead placement) utilizing a BIOTRONIK CRT-D system with IS4 LV port and Sentus QP LV lead
  • Patient is able to understand the nature of the clinical investigation and provide written informed consent
  • Patient is able and willing to complete all routine study visits at the investigational site through 5 years of follow-up
  • Patient accepts Home Monitoring® concept
  • Age ≥ 18 years
Main Exclusion Criteria
  • Contraindication to CRT-D therapy
  • Currently implanted with an endocardial or epicardial left ventricular lead or had prior attempt to place a left ventricular lead
  • Cardiac surgical procedure, such as coronary artery bypass graft, valve surgery, or ablation that is planned to occur within 6 months after implant (ablations planned to occur prior to or at implant are not exclusionary)
  • Expected to receive a heart transplant or ventricular assist device within 6 months
  • Life expectancy less than 12 months
  • Participation in any other investigational cardiac clinical investigation during the course of the study
  • Presence of another life-threatening, underlying illness separate from their cardiac disorder
  • Pregnant or breast-feeding at time of enrollment
Devices
  • BIOTRONIK CRT-D with IS4 LV port (Currently Itrevia HF-T QP CRT-D)
  • Investigational: Sentus OTW QP L LV lead and Sentus OTW QP S LV lead
Follow-Up
Study Duration
  • Study start date January 2015. Estimated study completion May 2023.
Principal Investigators
  • Prof. Antonio Curnis, Spedali Civili - Universita di Brescia, Italy
  • Dr. Mattias Roser, Charité CBF Berlin, Germany