Heart Failure Clinical Trial
Official title:
BIO|MASTER.Pamira Study
Verified date | January 2024 |
Source | Biotronik SE & Co. KG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Biotronik SE & Co. KG |
Australia, Austria, Belgium, Germany, Hungary, Israel, Latvia, Slovakia,
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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