TD01 Master Study (Safety and Efficacy Study)

TD01 Master Study (Safety and Efficacy Study)

This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD lead.

Inclusion Criteria:

• Meet standard indication for ICD/CRT-D therapy
• First ICD/CRT-D implantation or upgrade from pacemaker
• Duly signed informed consent form
• Willing to participate for the whole study duration
• Patient accepts Home Monitoring concept and is able to activate and use the CardioMessenger
• Patient has a 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
• 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
• Known dexamethasone acetate intolerance