DF4 Master Study (Safety and Efficacy Study)

Biotronik

Status: Completed

Conditions: Ventricular Fibrillation; Heart Failure; Sudden Cardiac Death; Ventricular Tachycardia

Treatments: Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego

Study type: Observational

Funder types: Industry

Identifiers

NCT01790841

54

Details and patient eligibility

About

The purpose of the study is to proof the safety and efficacy of the new ICD sytem (Iforia/Ilesto). The devices are available with DF-1 and DF4 connection. A special focus is set on the ICD system with DF4 connection.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has provided written informed consent.
• Patient has standard ICD/CRT-D indication.
• Patient accepts Home Monitoring concept.
• Patient is able to attend the planned hospital follow-up visits.
• Patient has legal capacity and ability to consent.

Exclusion criteria

• Patient has a standard contra-indication for ICD/CRT-D therapy.
• Age < 18 years
• Patient is pregnant or breastfeeding.
• Patient is expected to receive ventricular assist device or heart transplantation within the next 12 months.
• Life expectancy of less than 12 months.
• Participating in any other clinical study of an investigational cardiac drug or device.

Trial design

240 participants in 2 patient groups

ICD system with DF4 connection

Description:

Iforia/Ilesto ICD with DF4 connection and Linox smart DF4 lead/ Protego

Treatment:

Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego

ICD system with DF-1 connection

Description:

Ilesto/Iforia ICD with DF-1 connection

Treatment:

Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego