Iperia/Sentus QP Study

Study Overview
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Brief Summary
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The objective of this study is to confirm the safety and efficacy of the new Sentus OTW QP LV lead and Iperia ICD family. The study focuses on the safety and efficacy of the QP device system.

Official Title
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Iperia Family / Sentus QP Master Study

Conditions
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Heart Failure, Tachyarrhythmia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is able to understand the nature of the study and provides written informed consent. Patient meets a standard indication for CRT-D (Sentus QP group) or ICD therapy. Patient is able and willing to complete the planned follow-up visits at the investigational site. Patient accepts the Home Monitoring® concept. Age is ≥ 18 years. Sentus QP group only: Patient is a candidate for a new (de novo) implant or an upgrade from an existing ICD or pacemaker utilizing a BIOTRONIK Sentus QP lead Exclusion Criteria: Patient has a standard contraindication for CRT-D (Sentus QP group) or ICD therapy. Sentus QP group only: Currently implanted with an endocardial or epicardial LV lead or had prior attempt to place a LV lead. Sentus QP group only: Cardiac surgery procedure (coronary bypass graft, valve surgery, or ablation) that is planned to occur within 3 months after implantation. Patient is expected to receive ventricular assist device or heart transplantation within the next 3 months. Patient is pregnant or breastfeeding. Life expectancy of less than 3 months Participating in another cardiac clinical investigation with active treatment arm.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sentus QP group<br>Patients with standard indication for CRT-D therapy who will be implanted with Sentus QP LV lead and the BIOTRONIK HF-T QP device. | |
| VR-T/DR-T group<br>Patients with standard indication for ICD therapy who will be implanted with either single chamber ICD or dual chamber ICD of the Iperia ICD family | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sentus QP LV lead: Serious Adverse Device Effect (SADE) free rate | The safety of the LV lead will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the LV lead will be the basis for endpoint calculation of the SADE-free rate. | 3 months | 
| Iperia ICD family: SADE free rate | The safety of the Iperia ICD family will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the pacemaker will be the basis for endpoint calculation of the SADE-free rate. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LV pacing threshold | Lv pacing threshold measured in the final programmed pacing vector | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quadripolar CRT-D system, Heart Failure, Iperia ICD family, Sentus QP left ventricular lead