TD01 Master Study (Safety and Efficacy Study)

October 27, 2021 updated by: Biotronik SE & Co. KG
This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD lead.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria
        • Kepler Universitätsklinikum
  • Germany
      • Berlin, Germany
        • Vivantes-Krankenhaus Neukölln
      • Chemnitz, Germany
        • Drk Krankenhaus Chemnitz-Rabenstein
      • Kösching, Germany
        • Kliniken im Naturpark Altmühltal
    • Brandenburg
      • Frankfurt (Oder), Brandenburg, Germany, 15236
        • Klinikum Frankfurt (Oder) GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients selected for the investigation should be from the investigator's general patient population according to the inclusion and exclusion criteria.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ICD/ CRT-D therapy
Device: First ICD/CRT-D implantation or upgrade from pacemaker
Other Names:
  • 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
  • (or successor)
  • Free choice of additional RA and/or LV lead (if applicable)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 month follow-up
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.
3 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SADE-free Rate Related to TD01
Time Frame: 3 month follow-up

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.
3 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Investigators

  • Principal Investigator: Oliver Gunkel, Dr. med., Coordinating Investigator, former PI at the Klinikum Frankfurt (Oder)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 12, 2014

First Posted (Estimate)

March 14, 2014

Study Record Updates

Last Update Posted (Actual)

December 3, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TA107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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