This trial is active, not recruiting.

Conditions ventricular fibrillation, ventricular tachycardia, heart failure
Treatment sd01 icd lead
Sponsor Biotronik SE & Co. KG
Start date March 2014
End date April 2020
Trial size 280 participants
Trial identifier NCT02014675, 67 (TA108)


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
sd01 icd lead

Primary Outcomes

SADE-free rate
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - Meet a standard contraindication for an ICD/CRT-D therapy - Age <18 years - Pregnant or breast-feeding women - 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 - Dexamethasone acetate intolerance

Additional Information

Official title SD01 Registry (SD01 ICD Lead)
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Biotronik SE & Co. KG.