DF4 Master Study (Safety and Efficacy Study)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01790841
First received: February 12, 2013
Last updated: April 11, 2014
Last verified: April 2014

February 12, 2013
April 11, 2014
February 2013
November 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01790841 on ClinicalTrials.gov Archive Site
Comparison of automatic atrial pacing threshold test vs. manual measurement [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
DF4 Master Study (Safety and Efficacy Study)
Master Study of the BIOTRONIK DF4 System

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Ventricular Tachycardia
  • Ventricular Fibrillation
  • Sudden Cardiac Death
  • Heart Failure
Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego
  • ICD system with DF4 connection
    Iforia/Ilesto ICD with DF4 connection and Linox smart DF4 lead/ Protego
    Intervention: Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego
  • ICD system with DF-1 connection
    Ilesto/Iforia ICD with DF-1 connection
    Intervention: Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
237
May 2016
November 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01790841
54
No
Biotronik SE & Co. KG
Biotronik SE & Co. KG
Not Provided
Not Provided
Biotronik SE & Co. KG
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP