SD01 Master Study (Safety and Efficacy Study)

Biotronik

Status: Completed

Conditions: Ventricular Fibrillation; Heart Failure; Ventricular Tachycardia

Treatments: Device: SD01 ICD lead

Study type: Observational

Funder types: Industry

Identifiers

NCT01836497

TA103

Details and patient eligibility

About

The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.

Enrollment: 163 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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