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Completed

NCT Number: NCT01790841

DF4 Master Study (Safety and Efficacy Study)

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.

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Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Death Tachycardia Tachycardia, Ventricular Ventricular Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitaetsmedizin Greifswald

Greifswald, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego

Device

Primary outcomes

  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 outcomes

  1. Comparison of automatic atrial pacing threshold test vs. manual measurement

    Time frame: 3 month follow-up

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

Master Study of the BIOTRONIK DF4 System

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Feb 13, 2013
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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