Ventricular TachycardiaNCT01790841
DF4 Master Study (Safety and Efficacy Study)
An observational study of Ventricular Tachycardia and Ventricular Fibrillation, run by Biotronik SE & Co. KG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ventricular Fibrillation, Sudden Cardiac Death
- What is being tested?
- Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego
- Type of treatment
- Medical device
- How many people
- 240 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2013to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with standard ICD/CRT-D indication who are referred to the hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation, Death, Sudden, Cardiac, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ ProtegoDevice
| Study group | Role | What they receive |
|---|---|---|
| ICD system with DF4 connection | Iforia/Ilesto ICD with DF4 connection and Linox smart DF4 lead/ Protego Receives: Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego | |
| ICD system with DF-1 connection | Ilesto/Iforia ICD with DF-1 connection Receives: Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious adverse device effect (SADE) rate related to the ICD with DF4 connection
Measured: until 3 month follow-up
SADE rate related to the Linox smart DF4 lead (ICD shock lead)
Measured: until 3 month follow-up
Shift rate of the painless shock impedance measurement
Measured: between 3 and 6 month follow-up
Pacing threshold comparison between Linox smart DF-1 and Linox smart DF4 lead
Measured: 3 month follow-up
Secondary outcomes (1)
Comparison of automatic atrial pacing threshold test vs. manual measurement
Measured: 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790841
- Sponsor's protocol ID
- 54
- Status last verified
- Apr 2016
- First submitted
- 12 Feb 2013
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Master Study of the BIOTRONIK DF4 System
- ClinicalTrials.gov ID
- NCT01790841
- Acronym / sponsor ID
- 54
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICD system with DF4 connection | – | Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ ProtegoIforia/Ilesto ICD with DF4 connection and Linox smart DF4 lead/ Protego |
| ICD system with DF-1 connection | – | Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ ProtegoIlesto/Iforia ICD with DF-1 connection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with standard ICD/CRT-D indication who are referred to the hospital.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego | Device | ICD system with DF-1 connection, ICD system with DF4 connection |
Primary outcome
Serious adverse device effect (SADE) rate related to the ICD with DF4 connection
Time frame: until 3 month follow-up
SADE rate related to the Linox smart DF4 lead (ICD shock lead)
Time frame: until 3 month follow-up
Shift rate of the painless shock impedance measurement
Time frame: 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
1 secondary outcome
Comparison of automatic atrial pacing threshold test vs. manual measurement
Time frame: 3 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
Related trials for Ventricular Tachycardia
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia and Ventricular Fibrillation, run by Biotronik SE & Co. KG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious adverse device effect (SADE) rate related to the ICD with DF4 connection (time frame: until 3 month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.