DF4 Master Study (Safety and Efficacy Study)
Master Study of the BIOTRONIK DF4 System
1 other identifier
observational
240
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 12, 2013
CompletedFirst Posted
Study publicly available on registry
February 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedApril 19, 2016
April 1, 2016
2.2 years
February 12, 2013
April 18, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
Serious adverse device effect (SADE) rate related to the ICD with DF4 connection
until 3 month follow-up
SADE rate related to the Linox smart DF4 lead (ICD shock lead)
until 3 month follow-up
Shift rate of the painless shock impedance measurement
between 3 and 6 month follow-up
Pacing threshold comparison between Linox smart DF-1 and Linox smart DF4 lead
3 month follow-up
Secondary Outcomes (1)
Comparison of automatic atrial pacing threshold test vs. manual measurement
3 month follow-up
Study Arms (2)
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
Interventions
Eligibility Criteria
Patients with standard ICD/CRT-D indication who are referred to the hospital.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitaetsmedizin Greifswald
Greifswald, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2013
First Posted
February 13, 2013
Study Start
February 1, 2013
Primary Completion
May 1, 2015
Study Completion
April 1, 2016
Last Updated
April 19, 2016
Record last verified: 2016-04