- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01790841
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
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
-
-
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Greifswald, Germany
- Universitaetsmedizin Greifswald
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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
|
|
ICD system with DF-1 connection
Ilesto/Iforia ICD with DF-1 connection
|
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
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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
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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
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
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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