Clinical trial NCT02774616: BIO|MASTER.Ilivia Family / Plexa
Official title: BIO|MASTER.Ilivia Family / Plexa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Tachyarrhythmia
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2016-05-17
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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


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

Primary outcomes:
measure: Ilivia Family Related SADE-free Rate Through 3 Months
timeFrame: 3 months
measure: Plexa Related SADE-free Rate Through 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up
timeFrame: 6 months
measure: Rate of Appropriate Right Ventricular Sensing at 3-month Follow-up
timeFrame: 3 months
measure: Rate of Appropriate Right Ventricular Pacing at the 3 Months Follow-up
timeFrame: 3 months
Other outcomes:
Locations:
city: Liverpool
country: Australia
facility: Liverpool Hospital
city: Nambour
country: Australia
facility: Nambour General Hospital
city: St. Pölten
country: Austria
facility: Universitätsklinikum St. Pölten
city: Odense
country: Denmark
facility: Odense University Hospital
city: Brest
country: France
facility: CHU Brest
city: Bad Langensalza
country: Germany
facility: Hufeland Klinikum GmbH
city: Bad Oeynhausen
country: Germany
facility: HDZ NRW Bad Oeynhausen
city: Brandenburg
country: Germany
facility: Städtisches Klinikum Brandenburg GmbH
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera GmbH
city: Kaiserslautern
country: Germany
facility: Westpfalz-Klinikum Kaiserslautern
city: Singen
country: Germany
facility: Hegau-Bodensee-Klinikum Singen
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Singapore
country: Singapore
facility: National Heart Center Singapore
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
city: San Sebastian
country: Spain
facility: Hospital de Donostia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Macarena
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Luzern
country: Switzerland
facility: Kantonspital Luzern
Study officials:
affiliation: Universitätsspital Basel
name: Christian Sticherling, Prof. Dr.
role: STUDY_CHAIR
References: