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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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.

Country

City, postcode or hospital

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

Other trials in Germany

Austria1 site

Kepler Universitätsklinikum
Linz

Other trials in Austria

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 groups in NCT02087189
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.

Aug 201431 Mar 2020

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)

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

Results posted to the registry on 3 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ICD/ CRT-D Therapy With TD01 as ICD Lead	30	28

Primary outcome: TD01 Pacing Threshold

Time frame: 3 month follow-up. Median (95% Confidence Interval). Unit: V

Measure	ICD/ CRT-D Therapy With TD01 as ICD Lead n = 20
Value	0.5 (0.3 to 0.6)

Population analysed: per protocol analysis

Primary outcome: TD01 Sensing Amplitude

Time frame: 3 month follow-up. Median (95% Confidence Interval). Unit: mV

Measure	ICD/ CRT-D Therapy With TD01 as ICD Lead n = 20
Value	19.6 (16.1 to 21.4)

Population analysed: per protocol analysis

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ICD/ CRT-D Therapy With TD01 as ICD Lead	19 of 28 (67.9%)	0 of 28 (0%)	6 of 28

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?

On the ClinicalTrials.gov record for NCT02087189.

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.