NCT02014675Completed
SD01 Registry (SD01 ICD Lead)
Source: ClinicalTrials.gov · Last updated 23 Jan 2025
Brief summary (registry, in English)
This registry is designed to gather further evidence, in addition to the SD01 Master Study, for the safety and efficacy of the SD01 ICD lead.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 280 (estimated)
- First submitted
- 4 Dec 2013
- Start date
- Mar 2014
- Primary completion date
- 26 Sept 2024
- Lead sponsor
- Biotronik SE & Co. KG
- Diseases
- Heart failure
- NCT number
- NCT02014675
What you commit to
- Study type: Observational
- Planned participants: 280
- From Mar 2014 to the primary completion date, 26 Sept 2024
- 10 sites in 1 country
- 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
- Meet a standard contraindication for an ICD/CRT-D therapy
- Dexamethasone acetate intolerance
Other illness
- Cardiac surgery planned within the next six months
- Enrollment in another cardiac clinical investigation with active treatment arm
- Mechanical tricuspid valve prosthesis or severe tricuspid valve disease
Age
- Age \<18 years
Other
- Pregnant or breast-feeding women
Who the study is looking for
- Meet a standard indication for ICD/CRT-D therapy
- First ICD/CRT-D implantation or upgrade from pacemaker
- Signed informed consent form
- Willing to participate for the whole duration of the registry
- Patient accepts Home Monitoring concept and is able to activate and use the Cardiomessenger
- Patient has legal capacity and ability to consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vivantes, Humboldt-Klinikum Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| DRK Klinikum Berlin-Köpenick Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Universitares Herzzentrum Hamburg Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Klinikum Leverkusen Coordinator of this site? Confirm its status | Leverkusen | Germany | Unknown status |
| University Clinic of Schleswig-Holstein Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
| Carl-von-Basedow Klinik Coordinator of this site? Confirm its status | Merseburg | Germany | Unknown status |
| Marienkrankenhaus Papenburg Coordinator of this site? Confirm its status | Papenburg | Germany | Unknown status |
| DRK Krankenhaus Moelln-Ratzeburg Coordinator of this site? Confirm its status | Ratzeburg | Germany | Unknown status |
| SRH Zentralklinikum Suhl Coordinator of this site? Confirm its status | Suhl | Germany | Unknown status |
| Universitätsklinik Würzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.