Status:
COMPLETED
SD01 Master Study (Safety and Efficacy Study)
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Ventricular Tachycardia
Ventricular Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Standard contraindication for an ICD/CRT-D therapy
- Age \<18 years.
- Pregnant or breastfeeding
- 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
- Dexamethasone acetate intolerance
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 25 2024
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT01836497
Start Date
May 1 2013
End Date
September 25 2024
Last Update
January 22 2025
Active Locations (14)
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1
St. Ann University Hospital
Brno, Czechia
2
CHU de Saint-Etienne
Saint-Etienne, France
3
Hopital Civil Strasbourg
Strasbourg, France
4
Helios Klinik Aue
Aue, Germany