Heart Failure, Tachyarrhythmia
Conditions
Keywords
Heart Failure, Iperia ICD family, Sentus QP left ventricular lead, Quadripolar CRT-D system
Brief summary
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.
Interventions
None listed
Sponsors
Biotronik SE & Co. KG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sentus QP LV lead: Serious Adverse Device Effect (SADE) free rate | 3 months | 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. |
| Iperia ICD family: SADE free rate | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LV pacing threshold | 3 months | Lv pacing threshold measured in the final programmed pacing vector |
Other
| Measure | Time frame |
|---|---|
| Collection of data of interest: Handling of LV lead during implantation | 3 months |
Countries
Austria, Denmark, Finland, Germany, Italy, Latvia, Netherlands, Singapore, Spain, Switzerland, United Kingdom
Outcome results
None listed