SD01 Registry (SD01 ICD Lead)

Biotronik

Status: Completed

Conditions: Ventricular Fibrillation; Heart Failure; Ventricular Tachycardia

Treatments: Device: SD01 ICD lead

Study type: Observational

Funder types: Industry

Identifiers

NCT02014675

67 (TA108)

Details and patient eligibility

About

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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

280 participants in 1 patient group

SD01 ICD lead

Treatment:

Device: SD01 ICD lead