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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05621187
Other study ID # TA117
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 30, 2022
Est. completion date February 28, 2025

Study information

Verified date January 2024
Source Biotronik SE & Co. KG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 221
Est. completion date February 28, 2025
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Pamira ICD lead family
Implantation, measurements and follow-up schedule

Locations

Country Name City State
Australia John Hunter Hospital New Lambton Heights New South Wales
Austria Medizinische Universität Graz Graz Steiermark
Belgium UZ Brussels Jette
Belgium UZ Leuven Gasthuisberg Leuven
Germany St. Marienkrankhaus Klinikum Westmünsterland GmbH Ahaus Nordrhein-Westfalen
Germany Immanuel Klinikum Bernau Herzzentrum Brandenburg Bernau Brandenburg
Germany Städtisches Klinikum Brandenburg GmbH Brandenburg
Germany Städtisches Klinikum Dresden-Friedrichstadt Dresden Sachsen
Germany Universitätsklinikum Erlangen Erlangen Bayern
Germany SRH Wald-Klinikum Gera GmbH Gera Thüringen
Germany Otto-von-Guericke-Universität Magdeburg Magdeburg Sachsen-Anhalt
Germany Klinikum der Universität München München Bayern
Germany Klinikum Dorothea Christiane Erxleben Quedlinburg Quedlinburg Sachsen-Anhalt
Germany SRH Zentralklinikum Suhl GmbH Suhl Thüringen
Germany Universitätsklinikum Würzburg Würzburg Bayern
Hungary State Hospital of Cardiology Balatonfüred
Hungary Semmelweis University Budapest
Hungary The University of Pécs Pécs
Israel Assuta Medical Center Ashdod
Israel Soroka Medical Center Beer-Sheva
Israel Shaare Zedek MC Jerusalem
Latvia Pauls Stradins Clinical University Hospital Riga
Slovakia Stredoslovenský ústav srdcových a cievnych chorôb, a.s. (SÚSCCH, a.s.) Banská Bystrica

Sponsors (1)

Lead Sponsor Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Germany,  Hungary,  Israel,  Latvia,  Slovakia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pamira lead related SADE-d free rate at 6 months after implantation 6 months
Secondary 1a and b: Pamira lead related SADE-d free rate at 3 and 12 months after implantation 3 months, 12 months
Secondary 2a and 2b: Rate of appropriate right ventricular sensing at the 6- and 12-month follow-up 6 months, 12 months
Secondary 3a and 3b: Rate of appropriate right ventricular pacing at the 6- and 12-month follow-up 6 months, 12 months
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