DF4 Master Study (Safety and Efficacy Study)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
First received: February 12, 2013
Last updated: April 11, 2014
Last verified: April 2014

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.

Condition Intervention
Ventricular Tachycardia
Ventricular Fibrillation
Sudden Cardiac Death
Heart Failure
Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Master Study of the BIOTRONIK DF4 System

Resource links provided by NLM:

Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • Serious adverse device effect (SADE) rate related to the ICD with DF4 connection [ Time Frame: until 3 month follow-up ] [ Designated as safety issue: Yes ]
  • SADE rate related to the Linox smart DF4 lead (ICD shock lead) [ Time Frame: until 3 month follow-up ] [ Designated as safety issue: Yes ]
  • Shift rate of the painless shock impedance measurement [ Time Frame: between 3 and 6 month follow-up ] [ Designated as safety issue: Yes ]
  • Pacing threshold comparison between Linox smart DF-1 and Linox smart DF4 lead [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of automatic atrial pacing threshold test vs. manual measurement [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 237
Study Start Date: February 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ICD system with DF4 connection
Iforia/Ilesto ICD with DF4 connection and Linox smart DF4 lead/ Protego
Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego
ICD system with DF-1 connection
Ilesto/Iforia ICD with DF-1 connection
Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with standard ICD/CRT-D indication who are referred to the hospital.


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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01790841

Universitaetsmedizin Greifswald
Greifswald, Germany
Sponsors and Collaborators
Biotronik SE & Co. KG
  More Information

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01790841     History of Changes
Other Study ID Numbers: 54
Study First Received: February 12, 2013
Last Updated: April 11, 2014
Health Authority: Austria: AGES (Bundesamt für Sicherheit im Gesundheitswesen)
Italy: Ministry of Labour, Health and Social Affairs
France: French medicines and healthcare products safety agency

Additional relevant MeSH terms:
Ventricular Fibrillation
Heart Failure
Tachycardia, Ventricular
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Heart Arrest
Death, Sudden

ClinicalTrials.gov processed this record on April 17, 2014