Phase
Condition
Chest Pain
Heart Failure
Hyponatremia
Treatment
Acticor/Rivacor ICDs/CRT-Ds
Plexa S DX
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Standard indication for ICD or CRT-D therapy according to clinical guidelines
Planned for de novo implantation of an ICD/CRT-D, or upgrade/exchange from existingICD/CRT-D or pacemaker implant
Able to understand the nature of study and to provide written informed consent
Willing and able to perform all follow-up visits at the study site
Willing and able to use the CardioMessenger and accepts the BIOTRONIK HomeMonitoring concept
Exclusion
Exclusion Criteria:
Contraindication to ICD and CRT-D therapy
Planned for implantation of a CRT-DX system
For VR-T DX devices: permanent atrial tachyarrhythmia
For VR-T DX devices: patients requiring atrial pacing
Less than 18 years old
Pregnant or breast feeding
Participating in another interventional clinical investigation
Life-expectancy is less than 12 months
Cardiac surgical procedure planned within 12 months after implantation (includinginterventional procedures like ablation, valve replacement, heart transplant etc.).Procedures to occur during or prior to implantation are not exclusionary
Study Design
Connect with a study center
Kepler Universitätsklinikum
Linz,
AustriaSite Not Available
Herz- und Diabeteszentrum NRW
Bad Oeynhausen,
GermanySite Not Available
Charité Universitätsmedizin Berlin
Berlin,
GermanySite Not Available
Klinikum Coburg
Coburg,
GermanySite Not Available
SRH Wald-Klinikum Gera GmbH
Gera,
GermanySite Not Available
SRH Zentralklinikum Suhl
Suhl,
GermanySite Not Available
Universitätsklinikum Würzburg
Würzburg,
GermanySite Not Available
National Hospital of Cardiology
Balatonfüred,
HungarySite Not Available
Semmelweis Medical University
Budapest,
HungarySite Not Available
Pauls Stradins Clinical University Hospital
Riga,
LatviaSite Not Available
Hospital Medisch Spectrum Twente
Enschede,
NetherlandsSite Not Available
Erasmus Medical Center
Rotterdam,
NetherlandsSite Not Available
East-Slovak Cardiology Institute (VUSCH)
Košice,
SlovakiaSite Not Available
Inselspital - Universitätsspital Bern
Bern,
SwitzerlandSite Not Available
Universitätsspital Zürich
Zürich,
SwitzerlandSite Not Available

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