Ventricular FibrillationSD01 RegistryNCT02014675
SD01 Registry (SD01 ICD Lead)
An observational study of Ventricular Fibrillation and Ventricular Tachycardia, run by Biotronik SE & Co. KG at 10 sites in Germany.
Trial summary
This registry is designed to gather further evidence, in addition to the SD01 Master Study, for the safety and efficacy of the SD01 ICD lead. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Fibrillation, Ventricular Tachycardia, Heart Failure
- What is being tested?
- SD01 ICD lead
- Type of treatment
- Medical device
- How many people
- 280 participants
- Where
- 10 sitesGermany
- Study dates
- Mar 2014to 26 Sep 2024
- How long will I take part?
- 10 Years
- 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 (cardiac resynchronization therapy plus defibrillator) indication
Who may be able to join
- Meet a standard indication for ICD/CRT-D therapy
- First ICD/CRT-D implantation or upgrade from pacemaker
- Signed informed consent form
- Willing to participate for the whole duration of the registry
- Patient accepts Home Monitoring concept and is able to activate and use the Cardiomessenger
- Patient has legal capacity and ability to consent
Who cannot join
- Meet a standard contraindication for an ICD/CRT-D therapy
- Age <18 years
- Pregnant or breast-feeding women
- Cardiac surgery planned within the next six months
- Enrollment in another cardiac clinical investigation with active treatment arm
- Mechanical tricuspid valve prosthesis or severe tricuspid valve disease
- Dexamethasone acetate intolerance
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
DRK Klinikum Berlin-Köpenick
Berlin
Vivantes Humboldt Klinikum Berlin
Berlin
Universitäres Herzzentrum Hamburg
Hamburg
Klinikum Leverkusen
Leverkusen
University Clinic of Schleswig-Holstein
Lübeck, 23538
Carl-von-Basedow Klinik
Merseburg
Marienkrankenhaus Papenburg
Papenburg
DRK Krankenhaus Moelln-Ratzeburg
Ratzeburg
SRH Zentralklinikum Suhl
Suhl
Universitätsklinik Würzburg
Würzburg
About this study
This registry is designed to gather further evidence, in addition to the SD01 Master Study, for the safety and efficacy of the SD01 ICD lead.
- Being tested
- SD01 ICD lead
- Keywords
- ICD, CRT-D, Lead
- Medical subject headings
- Ventricular Fibrillation, Tachycardia, Ventricular, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SD01 ICD leadDevice
| Study group | Role | What they receive |
|---|---|---|
| SD01 ICD lead | Not described Receives: Device: SD01 ICD lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
SADE-free rate
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startMar 2014
- Primary completion26 Sep 2024
- Study completion26 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular FibrillationStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
- Target duration
- 10 Years
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
- NCT02014675
- Sponsor's protocol ID
- 67 (TA108)
- Acronym
- SD01 Registry
- Status last verified
- Jan 2024
- First submitted
- 4 Dec 2013
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SD01 Registry (SD01 ICD Lead)
- ClinicalTrials.gov ID
- NCT02014675
- Acronym / sponsor ID
- SD01 Registry / 67 (TA108)
- Keywords
- ICD, CRT-D, Lead
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 18 Dec 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.
This registry is designed to gather further evidence, in addition to the SD01 Master Study, for the safety and efficacy of the SD01 ICD lead.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SD01 ICD lead | – | Device: SD01 ICD lead |
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 (cardiac resynchronization therapy plus defibrillator) indication
Key inclusion criteria (6 listed)
- Meet a standard indication for ICD/CRT-D therapy
- First ICD/CRT-D implantation or upgrade from pacemaker
- Signed informed consent form
- Willing to participate for the whole duration of the registry
- Patient accepts Home Monitoring concept and is able to activate and use the Cardiomessenger
Key exclusion criteria (7 listed)
- Meet a standard contraindication for an ICD/CRT-D therapy
- Age <18 years
- Pregnant or breast-feeding women
- Cardiac surgery planned within the next six months
- Enrollment in another cardiac clinical investigation with active treatment arm
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 |
|---|---|---|
| SD01 ICD lead | Device | SD01 ICD lead |
Primary outcome
SADE-free rate
Time frame: 10 years
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 23 Jan 2025.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Fibrillation and Ventricular Tachycardia, run by Biotronik SE & Co. KG at 10 sites 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 6 inclusion and 7 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 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
SADE-free rate (time frame: 10 years). 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 23 Jan 2025.