Post Market Clinical Follow-up Study for the Pamira ICD Lead Family
NCT ID: NCT05621187
Last Updated: 2025-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
221 participants
INTERVENTIONAL
2022-11-30
2025-01-20
Brief Summary
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* demonstrating clinical safety
* evaluating performance based on sensing and pacing assessment
* collecting additional data of interest to assess other aspects such as the handling and usability
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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All patients
Pamira ICD lead family
Implantation, measurements and follow-up schedule
Interventions
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Pamira ICD lead family
Implantation, measurements and follow-up schedule
Eligibility Criteria
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Inclusion Criteria
* Planned for de novo implantation of a BIOTRONIK ICD or CRT-D in combination with Pamira
* Ability to understand the nature of the study and willingness to provide written informed consent
* Ability and willingness to perform all follow-up visits at the study site
* Ability and willingness to use the CardioMessenger and acceptance the BIOTRONIK Home Monitoring® concept
Exclusion Criteria
* Known Dexamethasone acetate intolerance
* Cardiac surgical post-implantation procedure planned within 12 months (including interventional procedures like ablation, valve replacement, heart transplant etc.)
* Less than 18 years old
* Pregnant or breast feeding
* Participating in another interventional clinical investigation
* Life-expectancy less than 12 months
18 Years
99 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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Thomas Deneke, Prof.
Role: PRINCIPAL_INVESTIGATOR
RHÖN-KLINIKUM Campus Bad Neustadt, Germany
Locations
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John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Medizinische Universität Graz
Graz, Styria, Austria
UZ Brussels
Jette, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
Klinikum der Universität München
München, Bavaria, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau bei Berlin, Brandenburg, Germany
St. Marienkrankhaus Klinikum Westmünsterland GmbH
Ahaus, North Rhine-Westphalia, Germany
Städtisches Klinikum Dresden-Friedrichstadt
Dresden, Saxony, Germany
Otto-von-Guericke-Universität Magdeburg
Magdeburg, Saxony-Anhalt, Germany
Klinikum Dorothea Christiane Erxleben Quedlinburg
Quedlinburg, Saxony-Anhalt, Germany
SRH Wald-Klinikum Gera GmbH
Gera, Thuringia, Germany
SRH Zentralklinikum Suhl GmbH
Suhl, Thuringia, Germany
Städtisches Klinikum Brandenburg GmbH
Brandenburg, , Germany
State Hospital of Cardiology
Balatonfüred, , Hungary
Semmelweis University
Budapest, , Hungary
The University of Pécs
Pécs, , Hungary
Assuta Medical Center
Ashdod, , Israel
Soroka Medical Center
Beersheba, , Israel
Shaare Zedek MC
Jerusalem, , Israel
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Stredoslovenský ústav srdcových a cievnych chorôb, a.s. (SÚSCCH, a.s.)
Banská Bystrica, , Slovakia
Countries
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Other Identifiers
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TA117
Identifier Type: -
Identifier Source: org_study_id
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