NCT01836497Completed
SD01 Master Study (Safety and Efficacy Study)
Source: ClinicalTrials.gov · Last updated 22 Jan 2025
Brief summary (registry, in English)
The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 163 (actual)
- First submitted
- 12 Apr 2013
- Start date
- May 2013
- Primary completion date
- Dec 2014
- Lead sponsor
- Biotronik SE & Co. KG
- Diseases
- Heart failure
- NCT number
- NCT01836497
What you commit to
- Study type: Observational
- Participants enrolled: 163
- From May 2013 to the primary completion date, Dec 2014
- 14 sites in 5 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
- Standard contraindication for an ICD/CRT-D therapy
- Dexamethasone acetate intolerance
Other illness
- Cardiac surgery is planned within the next six months
- Any condition that in the opinion of the investigator would preclude compliance with the study protocol during the whole follow-up period
- 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 breastfeeding
Who the study is looking for
- Standard indication for an ICD/CRT-D therapy
- Signed informed consent form
- Patient is willing and able to participate for the whole study duration
- Patient is willing and able to activate and use the CardioMessenger
- Legal capacity and ability to consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Ann University Hospital Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Helios Klinik Aue Coordinator of this site? Confirm its status | Aue | Germany | Unknown status |
| Universitätsklinikum Düsseldorf Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| Universitätsklinik Jena Coordinator of this site? Confirm its status | Jena | Germany | Unknown status |
| University Clinic of Schleswig-Holstein Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
| Carl-von-Basedow Clinic Coordinator of this site? Confirm its status | Merseburg | Germany | Unknown status |
| Städtisches Klinikum München Bogenhausen Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Klinik Rothenburg Coordinator of this site? Confirm its status | Rothenburg upon Tauber | Germany | Unknown status |
| Universitätsklinik Würzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| Chu de Saint Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Unknown status |
| Hopital Civil Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| Semmelweiss University Hospital Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Unknown status |
| Bovas P. Stradina KUS Latvian Center of Cardiology Coordinator of this site? Confirm its status | Riga | Latvia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.