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DF4 Master Study (Safety and Efficacy Study)

B

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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