SD01 Master Study (Safety and Efficacy Study)

SD01 Master Study (Safety and Efficacy Study)

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

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