Ventricular TachycardiaNCT01836497
SD01 Master Study (Safety and Efficacy Study)
An observational study of Ventricular Tachycardia and Ventricular Fibrillation, run by Biotronik SE & Co. KG at 14 sites in 5 countries.
Trial summary
The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ventricular Fibrillation, Heart Failure
- What is being tested?
- SD01 ICD lead
- Type of treatment
- Medical device
- How many people
- 163 participants
- Where
- 14 sitesin 5 countries
- Study dates
- May 2013to 25 Sep 2024
- 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
- Standard indication for an ICD/CRT-D therapy
- Signed informed consent form
- Patient is willing and able to participate for the whole study duration
- Patient is willing and able to activate and use the CardioMessenger
- Legal capacity and ability to consent.
Who cannot join
- Standard contraindication for an ICD/CRT-D therapy
- Age <18 years.
- Pregnant or breastfeeding
- Cardiac surgery is planned within the next six months
- Any condition that in the opinion of the investigator would preclude compliance with the study protocol during the whole follow-up period
- 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
14 sites in 5 countries.
14 sites in 5 countries
Germany8 sites
Helios Klinik Aue
Aue
Universitätsklinikum Düsseldorf
Düsseldorf
Universitätsklinik Jena
Jena
University Clinic of Schleswig-Holstein
Lübeck
Carl-von-Basedow Clinic
Merseburg
Städtisches Klinikum München Bogenhausen
München
Klinik Rothenburg
Rothenburg upon Tauber
Universitätsklinik Würzburg
Würzburg
France2 sites
CHU de Saint-Etienne
Saint-Etienne
Hopital Civil Strasbourg
Strasbourg
Hungary2 sites
Semmelweiss University Hospital
Budapest
University of Debrecen
Debrecen
About this study
The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.
- Being tested
- SD01 ICD lead
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SD01 ICD leadDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of appropriate sensing and pacing
The evaluation of right ventricular sensing performance is based on the assessment of consecutive intrinsic beats documented with markers on an IEGM (intra-cardiac electrogram). The evaluation of ventricular sensing performance is based on the data to be collected during the 3-month follow-up. The appropriate pacing performance in the right ventricle results from the evaluation of "capture" at the end of the 3-month follow-up.
Measured: at the 3-month follow-up
Serious adverse device effects (SADEs) related to the SD01 lead
Measured: until the 3-month follow-up
Secondary outcomes (2)
Comparison of pacing threshold between Linoxsmart and SD01
Comparison of the manually measured pacing threshold of the SD01 lead system to the Linox SD lead at 3-month follow-up. The idea is that the pacing threshold will be similar within a suitable range.
Measured: at the 3-month follow-up
Shift rate of the painless shock impedance measurement
Measured: between 3- and 6-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 posted22 Apr 2013 (estimated)
- Study startMay 2013
- Primary completion22 Dec 2014
- Study completion25 Sep 2024
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 only
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roland Richard Tilz, Prof. Dr. med., Principal investigator, University Clinic of Schleswig-Holstein, Lübeck, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836497
- Sponsor's protocol ID
- TA103
- Status last verified
- Jul 2024
- First submitted
- 12 Apr 2013
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SD01 Master Study (Safety and Efficacy Study)
- ClinicalTrials.gov ID
- NCT01836497
- Acronym / sponsor ID
- TA103
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- 22 Dec 2014 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 22 Apr 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 study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
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 (5 listed)
- Standard indication for an ICD/CRT-D therapy
- Signed informed consent form
- Patient is willing and able to participate for the whole study duration
- Patient is willing and able to activate and use the CardioMessenger
- Legal capacity and ability to consent.
Key exclusion criteria (8 listed)
- Standard contraindication for an ICD/CRT-D therapy
- Age <18 years.
- Pregnant or breastfeeding
- Cardiac surgery is planned within the next six months
- Any condition that in the opinion of the investigator would preclude compliance with the study protocol during the whole follow-up period
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 | – |
Primary outcome
Rate of appropriate sensing and pacing
Time frame: at the 3-month follow-up
The evaluation of right ventricular sensing performance is based on the assessment of consecutive intrinsic beats documented with markers on an IEGM (intra-cardiac electrogram). The evaluation of ventricular sensing performance is based on the data to be collected during the 3-month follow-up. The appropriate pacing performance in the right ventricle results from the evaluation of "capture" at the end of the 3-month follow-up.
Serious adverse device effects (SADEs) related to the SD01 lead
Time frame: until the 3-month follow-up
2 secondary outcomes
Comparison of pacing threshold between Linoxsmart and SD01
Time frame: at the 3-month follow-up
Shift rate of the painless shock impedance measurement
Time frame: between 3- and 6-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 22 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.
Roland Richard Tilz, Prof. Dr. med. principal investigator
University Clinic of Schleswig-Holstein, Lübeck, Germany
14 sites in 5 countries: 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 14 sites in 5 countries.
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 8 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 22 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 14 sites in Germany, France, Hungary, Czechia, Latvia. 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?
Rate of appropriate sensing and pacing (time frame: at the 3-month follow-up). The study lists 2 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 22 Jan 2025; AzTrials last refreshed its copy on 27 Oct 2026.