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OpenTrials
Completed

NCT Number: NCT02087189

TD01 Master Study (Safety and Efficacy Study)

This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD lead.

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Key information

Conditions

ICD/CRT-D Indication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kepler Universitätsklinikum, Linz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

First ICD/CRT-D implantation or upgrade from pacemaker

Device

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)

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2020
First posted
Mar 14, 2014
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.