NCT05621187Completed
Post Market Clinical Follow-up Study for the Pamira ICD Lead Family
BIO|MASTER.Pamira Study
Source: ClinicalTrials.gov · Last updated 26 Feb 2025
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 221 (actual)
- First submitted
- 7 Nov 2022
- Start date
- 30 Nov 2022
- Primary completion date
- 20 Jan 2025
- Lead sponsor
- Biotronik SE & Co. KG
- Diseases
- Heart failure
- NCT number
- NCT05621187
What you commit to
- Study type: Interventional
- Participants enrolled: 221
- From 30 Nov 2022 to the primary completion date, 20 Jan 2025
- 23 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known Dexamethasone acetate intolerance
Other illness
- Mechanical tricuspid valve prosthesis or a severe tricuspid valve disease
- Cardiac surgical post-implantation procedure planned within 12 months (including interventional procedures like ablation, valve replacement, heart transplant etc.)
Age
- Less than 18 years old
Other
- Pregnant or breast feeding
- Participating in another interventional clinical investigation
- Life-expectancy less than 12 months
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universität Graz Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| John Hunter Hospital Coordinator of this site? Confirm its status | New Lambton Heights | Australia | Unknown status |
| UZ Brussels Coordinator of this site? Confirm its status | Jette | Belgium | Unknown status |
| UZ Leuven Gasthuisberg Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| St. Marienkrankhaus Klinikum Westmünsterland GmbH Coordinator of this site? Confirm its status | Ahaus | Germany | Unknown status |
| Immanuel Klinikum Bernau Herzzentrum Brandenburg Coordinator of this site? Confirm its status | Bernau bei Berlin | Germany | Unknown status |
| Städtisches Klinikum Brandenburg GmbH Coordinator of this site? Confirm its status | Brandenburg | Germany | Unknown status |
| Städtisches Klinikum Dresden-Friedrichstadt Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Universitätsklinikum Erlangen Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
| SRH Wald-Klinikum Gera GmbH Coordinator of this site? Confirm its status | Gera | Germany | Unknown status |
| Otto-von-Guericke-Universität Magdeburg Coordinator of this site? Confirm its status | Magdeburg | Germany | Unknown status |
| Klinikum der Universität München Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Klinikum Dorothea Christiane Erxleben Quedlinburg Coordinator of this site? Confirm its status | Quedlinburg | Germany | Unknown status |
| SRH Zentralklinikum Suhl GmbH Coordinator of this site? Confirm its status | Suhl | Germany | Unknown status |
| Universitätsklinikum Würzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| State Hospital of Cardiology Coordinator of this site? Confirm its status | Balatonfüred | Hungary | Unknown status |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| The University of Pécs Coordinator of this site? Confirm its status | Pécs | Hungary | Unknown status |
| Assuta Medical Center Coordinator of this site? Confirm its status | Ashdod | Israel | Unknown status |
| Soroka Medical Center Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Shaare Zedek MC Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Pauls Stradins Clinical University Hospital Coordinator of this site? Confirm its status | Riga | Latvia | Unknown status |
| Stredoslovenský ústav srdcových a cievnych chorôb, a.s. (SÚSCCH, a.s.) Coordinator of this site? Confirm its status | Banská Bystrica | Slovakia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.