BIO|MASTER.Ilivia Family / Plexa

Status: Completed
Location: See all (25) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
Other Locations
Australia
Liverpool Hospital
Liverpool
Nambour General Hospital
Nambour
Austria
Universitätsklinikum St. Pölten
St. Pölten
Denmark
Odense University Hospital
Odense
France
CHU Brest
Brest
Germany
Hufeland Klinikum GmbH
Bad Langensalza
HDZ NRW Bad Oeynhausen
Bad Oeynhausen
Städtisches Klinikum Brandenburg GmbH
Brandenburg
Universitätsklinikum Erlangen
Erlangen
Universitätsklinikum Essen
Essen
Universitätsklinikum Freiburg
Freiburg
SRH Wald-Klinikum Gera GmbH
Gera
Westpfalz-Klinikum Kaiserslautern
Kaiserslautern
Hegau-Bodensee-Klinikum Singen
Singen
Universitätsklinikum Würzburg
Würzburg
Israel
Chaim Sheba Medical Center
Ramat Gan
Tel Aviv Sourasky Medical Center
Tel Aviv
Latvia
Pauls Stradins Clinical University Hospital
Riga
Singapore
National Heart Center Singapore
Singapore
Spain
Hospital de Bellvitge
Barcelona
Hospital de Donostia
San Sebastian
Hospital Universitario Virgen de Macarena
Sevilla
Switzerland
Universitätsspital Basel
Basel
Inselspital Bern
Bern
Kantonspital Luzern
Luzern
Time Frame
Start Date: June 2016
Completion Date: March 2018
Participants
Target number of participants: 292
Treatments
Other: Ilivia ICD Family
Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting
Other: Plexa ICD lead
Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting
Other: Ilivia ICD and Plexa lead
Implant of the new Ilivia ICD Family and the new Plexa lead. Device measurements, pre-defined programming and Adverse Event Reporting
Related Therapeutic Areas
Sponsors
Leads: Biotronik SE & Co. KG

This content was sourced from clinicaltrials.gov

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