TD01 Master Study (Safety and Efficacy Study)

Biotronik

Status: Completed

Conditions: ICD/CRT-D Indication

Treatments: Device: First ICD/CRT-D implantation or upgrade from pacemaker

Study type: Observational

Funder types: Industry

Identifiers

NCT02087189

TA107

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

ICD/ CRT-D therapy

Treatment:

Device: First ICD/CRT-D implantation or upgrade from pacemaker