DF4 Master Study (Safety and Efficacy Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01790841
Recruitment Status : Completed
First Posted : February 13, 2013
Last Update Posted : April 19, 2016
Information provided by (Responsible Party):
Biotronik SE & Co. KG

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

Study Type : Observational
Actual Enrollment : 240 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Master Study of the BIOTRONIK DF4 System
Study Start Date : February 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : April 2016

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Serious adverse device effect (SADE) rate related to the ICD with DF4 connection [ Time Frame: until 3 month follow-up ]
  2. SADE rate related to the Linox smart DF4 lead (ICD shock lead) [ Time Frame: until 3 month follow-up ]
  3. Shift rate of the painless shock impedance measurement [ Time Frame: between 3 and 6 month follow-up ]
  4. Pacing threshold comparison between Linox smart DF-1 and Linox smart DF4 lead [ Time Frame: 3 month follow-up ]

Secondary Outcome Measures :
  1. Comparison of automatic atrial pacing threshold test vs. manual measurement [ Time Frame: 3 month follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01790841

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

Responsible Party: Biotronik SE & Co. KG Identifier: NCT01790841     History of Changes
Other Study ID Numbers: 54
First Posted: February 13, 2013    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016

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