BIO|MASTER.Ilivia Family / Plexa

Biotronik

Status: Completed

Conditions: Heart Failure; Tachyarrhythmia

Treatments: Device: Ilivia ICD Family; Device: Plexa ICD lead

Study type: Interventional

Funder types: Industry

Identifiers

NCT02774616

TA111

Details and patient eligibility

About

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

Enrollment: 292 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

292 participants in 3 patient groups

Ilivia ICD Family

Other group

Description:

Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting

Treatment:

Device: Ilivia ICD Family

Plexa ICD lead

Other group

Description:

Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting

Treatment:

Device: Plexa ICD lead

Ilivia ICD and Plexa lead

Other group

Description:

Implant of the new Ilivia ICD Family and the new Plexa lead. Device measurements, pre-defined programming and Adverse Event Reporting

Treatment:

Device: Ilivia ICD Family

Device: Plexa ICD lead