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DF4 Master Study (Safety and Efficacy Study)

This study is currently recruiting participants.
Verified February 2013 by Biotronik SE & Co. KG
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01790841
First received: February 12, 2013
Last updated: February 15, 2013
Last verified: February 2013
History of Changes
  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

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:

MedlinePlus related topics: Heart Failure Shock
U.S. FDA Resources

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: March 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
 Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead
ICD system with DF-1 connection
Ilesto/Iforia ICD with DF-1 connection
 Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead

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

Contacts
Contact: Antje Rebmann +49 30 68905 ext 1234 antje.rebmann@biotronik.com

Locations
Germany
Universitaetsmedizin Greifswald Recruiting
Greifswald, Germany
Contact: Stephan Felix, Prof. Dr.            
Contact: Mathias Busch, Dr.            
Principal Investigator: Stephan Felix, Prof. Dr.            
Principal Investigator: Mathias Busch, Dr.            
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: February 15, 2013
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:
Heart Failure
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Death, Sudden, Cardiac
Death
 Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Heart Arrest
Death, Sudden

ClinicalTrials.gov processed this record on May 23, 2013