QP ExCELs Clinical Trial

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

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