ICD/CRT-D IndicationNCT02087189
TD01 Master Study (Safety and Efficacy Study)
An observational study of ICD/CRT-D Indication, run by Biotronik SE & Co. KG at 5 sites in 2 countries.
Trial summary
This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD lead. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICD/CRT-D Indication
- What is being tested?
- First ICD/CRT-D implantation or upgrade from pacemaker
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Aug 2014to 31 Mar 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: The patients selected for the investigation should be from the investigator's general patient population according to the inclusion and exclusion criteria.
Who may be able to join
- Meet standard indication for ICD/CRT-D therapy
- First ICD/CRT-D implantation or upgrade from pacemaker
- Duly signed informed consent form
- Willing to participate for the whole study duration
- Patient accepts Home Monitoring concept and is able to activate and use the CardioMessenger
- Patient has a 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
- 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
- Known dexamethasone acetate intolerance
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites
Vivantes-Krankenhaus Neukölln
Berlin
DRK Krankenhaus Chemnitz-Rabenstein
Chemnitz
Klinikum Frankfurt (Oder) GmbH
Frankfurt (Oder), Brandenburg, 15236
Kliniken im Naturpark Altmühltal
Kösching
About this study
This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD lead.
- Conditions
- ICD/CRT-D Indication
- Being tested
- First ICD/CRT-D implantation or upgrade from pacemaker
- Keywords
- ICD, CRT-D, lead
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First ICD/CRT-D implantation or upgrade from pacemakerDevice
Also called TD01 (investigational device), Lumax 540, 640 or 740: VR-T, DR-T or HF-T or, Ilesto 5 or Ilesto 7 DF-1: VR-T, DR-T or HF-T or, Iforia 3, 5 or Iforia 7 DF-1: VR-T, DR-T or HF-T
| Study group | Role | What they receive |
|---|---|---|
| ICD/ CRT-D therapy | Not described Receives: Device: First ICD/CRT-D implantation or upgrade from pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
TD01 Pacing Threshold
Non-inferiority of the pacing threshold compared to Linox TD. It is expected, that pacing thresholds of the TD01 leads will be statistically significant lower than 0.8V.
Pacing threshold is the minimal electrical stimulus (voltage) required to produce consistent cardiac depolarization (heart contraction). Linox TD is another (predecessor) electrode that is used for comparison.
Measured: 3 month follow-up
TD01 Sensing Amplitude
Non-inferiority of the sensing amplitude compared to Linox TD. It is expected, that the sensing amplitudes of the TD01 leads will be statistically significant higher than 9.7mV.
Sensing amplitude is the value for the measured voltage maximum (mV) during the ventricular depolarization (QRS complex during contraction). Linox TD is another (predecessor) electrode that is used for comparison.
Measured: 3 month follow-up
Secondary outcomes (1)
SADE-free Rate Related to TD01
SADE-free rate related to TD01. It is expected, that the SADE-free rate is higher than 0.9 (90%).
SADE Free Rate is a safety parameter and defined as p = 1 - number of SADEs divided by the number of TD01 leads implanted. Whereby Serious Adverse Device Effects (SADEs) are accounted that relate to the TD01 ICD lead and were observed between implantation until the predefined follow-up time, e.g. the three month follow-up.
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 posted14 Mar 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2015
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ICD/CRT-D IndicationStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oliver Gunkel, Dr. med., Principal investigator, Coordinating Investigator, former PI at the Klinikum Frankfurt (Oder)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087189
- Sponsor's protocol ID
- TA107
- Status last verified
- Jan 2020
- First submitted
- 4 Mar 2014
- Last updated
- 3 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TD01 Master Study (Safety and Efficacy Study)
- ClinicalTrials.gov ID
- NCT02087189
- Acronym / sponsor ID
- TA107
- Conditions
- ICD/CRT-D Indication
- Keywords
- ICD, CRT-D, lead
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Posted 3 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD lead.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICD/ CRT-D therapy | – | Device: First ICD/CRT-D implantation or upgrade from pacemaker |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients selected for the investigation should be from the investigator's general patient population according to the inclusion and exclusion criteria.
Key inclusion criteria (6 listed)
- Meet standard indication for ICD/CRT-D therapy
- First ICD/CRT-D implantation or upgrade from pacemaker
- Duly signed informed consent form
- Willing to participate for the whole study duration
- 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
- 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 |
|---|---|---|
| First ICD/CRT-D implantation or upgrade from pacemakerAlso: TD01 (investigational device), Lumax 540, 640 or 740: VR-T, DR-T or HF-T or, Ilesto 5 or Ilesto 7 DF-1: VR-T, DR-T or HF-T or, Iforia 3, 5 or Iforia 7 DF-1: VR-T, DR-T or HF-T | Device | ICD/ CRT-D therapy |
Primary outcome
TD01 Pacing Threshold
Time frame: 3 month follow-up
Non-inferiority of the pacing threshold compared to Linox TD. It is expected, that pacing thresholds of the TD01 leads will be statistically significant lower than 0.8V. Pacing threshold is the minimal electrical stimulus (voltage) required to produce consistent cardiac depolarization (heart contraction). Linox TD is another (predecessor) electrode that is used for comparison.
TD01 Sensing Amplitude
Time frame: 3 month follow-up
Non-inferiority of the sensing amplitude compared to Linox TD. It is expected, that the sensing amplitudes of the TD01 leads will be statistically significant higher than 9.7mV. Sensing amplitude is the value for the measured voltage maximum (mV) during the ventricular depolarization (QRS complex during contraction). Linox TD is another (predecessor) electrode that is used for comparison.
1 secondary outcome
SADE-free Rate Related to TD01
Time frame: 3 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Oliver Gunkel, Dr. med. principal investigator
Coordinating Investigator, former PI at the Klinikum Frankfurt (Oder)
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ICD/CRT-D Indication, run by Biotronik SE & Co. KG at 5 sites in 2 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 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 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Austria. 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?
Yes. Results are posted in the registry (first posted 3 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
TD01 Pacing Threshold (time frame: 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 3 Dec 2021.