Study Results
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View full resultsBasic Information
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COMPLETED
NA
292 participants
INTERVENTIONAL
2016-06-30
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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Ilivia ICD Family
Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting
Ilivia ICD Family
pre-defined device programming, measurements and follow-up schedule
Plexa ICD lead
Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting
Plexa ICD lead
predefined follow-up schedule
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
Ilivia ICD Family
pre-defined device programming, measurements and follow-up schedule
Plexa ICD lead
predefined follow-up schedule
Interventions
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Ilivia ICD Family
pre-defined device programming, measurements and follow-up schedule
Plexa ICD lead
predefined follow-up schedule
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Biotronik SE & Co. KG
INDUSTRY
Responsible Party
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Principal Investigators
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Christian Sticherling, Prof. Dr.
Role: STUDY_CHAIR
Universitätsspital Basel
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TA111
Identifier Type: -
Identifier Source: org_study_id
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