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COMPLETEDNA

Post Market Clinical Follow-up Study for the Pamira ICD Lead Family

BIO|MASTER.Pamira Study

NCT05621187•Biotronik SE & Co. KG

Summary

Confirm clinical safety and performance of the Pamira lead to support the regulatory post market strategy in Europe and other regions and validating promotional claims by * 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

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Standard indication for ICD or CRT-D therapy according to clinical guidelines
•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

•Mechanical tricuspid valve prosthesis or a severe tricuspid valve disease
•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

Locations (23)

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

Key Dates

Start Date

November 30, 2022

Primary Completion Date

January 20, 2025

Completion Date

January 20, 2025

Last Updated

February 26, 2025

Enrollment

221

ACTUAL participants

Conditions

Heart FailureTachyarrhythmia

Interventions

Pamira ICD lead family

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Post Market Clinical Follow-up Study for the Pamira ICD Lead Family

Inclusion Criteria

Exclusion Criteria

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