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QP ExCELs Clinical Trial

Sentus QP - Extended CRT Evaluation with Quadripolar Left Ventricular Leads

Study Design

  • Prospective, non-randomized, multi-center study
  • Designed to 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.

Key Results

A subanalysis of 120 matched pairs of CRT-and CRT-DX patients included in the study demonstrated that the CRT-DX system can provide similar CRT responses and significantly fewer complications when compared to a similar cohort with a conventional three-lead CRT-D system.

QP Excels key result 1

Figure 1: Freedom from primary endpoint major complications over total follow-up.

 

QP Excels key result 2

Figure 2: NYHA changes at 6 months follow-up. All percentages are displayed as absolute percentages (out of 120 subjects).

Study Details

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

Primary Endpoint

  • 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

Major Secondary 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

Main 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
  • Investigational: Sentus OTW QP L LV lead and Sentus OTW QP S LV lead

Study Duration

  • Study start date January 2015 - Study completion January 2023

Reference no.

  • NCT02290028

Principal Investigators

  • Prof. Antonio Curnis, Spedali Civili - Universita di Brescia, Italy
  • Dr. Mattias Roser, Charité CBF Berlin, Germany

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1 Brignole M et al. 2013 ESC Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy. European Heart Journal. 2013, 34(29).