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
  Purpose

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

  Eligibility

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
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:
Death, Sudden, Cardiac
Heart Failure
Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Death
Death, Sudden
Heart Arrest
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014