DF4 Master Study (Safety and Efficacy Study)

April 18, 2016 updated by: Biotronik SE & Co. KG

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Greifswald, Germany
        • Universitaetsmedizin Greifswald

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of automatic atrial pacing threshold test vs. manual measurement
Time Frame: 3 month follow-up
3 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

February 12, 2013

First Submitted That Met QC Criteria

February 12, 2013

First Posted (ESTIMATE)

February 13, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 54 (Other Identifier: Ondokuz Mayis University Clinical Research Ethics Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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