BIO|MASTER.Ilivia Family / Plexa
1 other identifier
interventional
292
9 countries
23
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Jun 2016
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2016
CompletedFirst Posted
Study publicly available on registry
May 17, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedResults Posted
Study results publicly available
March 26, 2019
CompletedMay 22, 2019
July 1, 2018
1.5 years
May 13, 2016
July 19, 2018
May 10, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Ilivia Family Related SADE-free Rate Through 3 Months
This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the ICD device
3 months
Plexa Related SADE-free Rate Through 6 Months
This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the "Plexa" lead
6 months
Secondary Outcomes (3)
Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up
6 months
Rate of Appropriate Right Ventricular Sensing at 3-month Follow-up
3 months
Rate of Appropriate Right Ventricular Pacing at the 3 Months Follow-up
3 months
Study Arms (3)
Ilivia ICD Family
OTHERImplant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting
Plexa ICD lead
OTHERImplant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting
Ilivia ICD and Plexa lead
OTHERImplant of the new Ilivia ICD Family and the new Plexa lead. Device measurements, pre-defined programming and Adverse Event Reporting
Interventions
pre-defined device programming, measurements and follow-up schedule
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Liverpool Hospital
Liverpool, Australia
Nambour General Hospital
Nambour, Australia
Universitätsklinikum St. Pölten
Sankt Pölten, Austria
Odense University Hospital
Odense, Denmark
CHU Brest
Brest, France
Hufeland Klinikum GmbH
Bad Langensalza, Germany
HDZ NRW Bad Oeynhausen
Bad Oeynhausen, Germany
Städtisches Klinikum Brandenburg GmbH
Brandenburg, Germany
Universitätsklinikum Erlangen
Erlangen, Germany
Universitätsklinikum Essen
Essen, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
SRH Wald-Klinikum Gera GmbH
Gera, Germany
Westpfalz-Klinikum Kaiserslautern
Kaiserslautern, Germany
Hegau-Bodensee-Klinikum Singen
Singen, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
Chaim Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Pauls Stradins Clinical University Hospital
Riga, Latvia
National Heart Center Singapore
Singapore, Singapore
Hospital de Bellvitge
Barcelona, Spain
Hospital de Donostia
Donostia / San Sebastian, Spain
Hospital Universitario Virgen de Macarena
Seville, Spain
Universitätsspital Basel
Basel, Switzerland
Inselspital Bern
Bern, Switzerland
Kantonspital Luzern
Lucerne, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director Clinical Project Management
- Organization
- Biotronik SE & Co.KG
Study Officials
- STUDY CHAIR
Christian Sticherling, Prof. Dr.
Universitätsspital Basel
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2016
First Posted
May 17, 2016
Study Start
June 1, 2016
Primary Completion
December 1, 2017
Study Completion
March 1, 2018
Last Updated
May 22, 2019
Results First Posted
March 26, 2019
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share