| Reference no. | |
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| 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
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| 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
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| 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
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| Clinical Sites | - Pre-market:
- Up to 75 sites (US), up to 125 sites (worldwide)
- Post-approval:
- Up to 75 sites (US)
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| Sample Size | - Pre-market:
- Up to 314 subjects
- Post-approval:
- Up to 1754 subjects
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| 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
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| 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
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| 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
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| Follow-Up | - Pre-hospital discharge/wound check, 3 month, 6 month and 12 month follow-up
- US sites continue every 6 months for 5 years post-implant
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| Study Duration | - Study start date January 2015. Estimated study completion May 2023.
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| Principal Investigators | - Prof. Antonio Curnis, Spedali Civili - Universita di Brescia, Italy
- Dr. Mattias Roser, Charité CBF Berlin, Germany
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