N/A
Completed N=278
BIO|MASTER.Ilivia Family / Plexa
Heart Failure · Tachyarrhythmia
Source: ClinicalTrials.gov NCT02774616 ↗
Enrolled (actual)
278
Serious AEs
35.4%
Results posted
Mar 2019
Primary outcomePrimary: Ilivia Family Related SADE-free Rate Through 3 Months — 91; 12 Participants — p=0.0004
Summary
Post-Market Clinical Follow-up of the new Ilivia ICD Family and the new Plexa right ventricular lead to fulfill requirements by the notified body and to support regulatory approval outside of the CE region
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ilivia Family Related SADE-free Rate Through 3 Months |
91; 12 | 0.0004 sig |
| PRIMARY Plexa Related SADE-free Rate Through 6 Months |
133; 12 | 0.0019 sig |
| SECONDARY Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up |
1 | — |
| SECONDARY Rate of Appropriate Right Ventricular Sensing at 3-month Follow-up |
145 | <0.0001 sig |
| SECONDARY Rate of Appropriate Right Ventricular Pacing at the 3 Months Follow-up |
150 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Standard indication for ICD or CRT-D therapy according to clinical practice
- De novo implantation or upgrade/exchange (group A only) from existing ICD, CRT-D or pacemaker implant
- Patient is able to understand the nature of the clinical investigation and provides written informed consent
- Patient is able and willing to complete all routine study visits at the investigational site
- Patient accepts Home Monitoring concept
- Age ≥ 18 years
Exclusion Criteria
- Contraindication to ICD or CRT-D therapy, respectively
- For CRT-D patients in group A only: physician not willing to activate MultiPole Pacing in the patient
- Cardiac surgical procedure planned within 6 months after implantation (including also interventional procedures like ablation, valve replacement etc.). Procedures to occur during or prior to implantation are not exclusionary.
- Expected to receive heart transplant or ventricular assist device within 6 months
- Life expectancy less than 6 months
- Participation in any other interventional clinical investigation
- Pregnant or breastfeeding at time of enrollment
Data sourced from ClinicalTrials.gov (NCT02774616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.