TD01 Master Study (Safety and Efficacy Study)

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

Study Overview

• Status: Completed
• Conditions: ICD/CRT-D Indication
• Intervention / Treatment: Device: First ICD/CRT-D implantation or upgrade from pacemaker

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

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

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

How is the study designed?

Number of groups / cohorts

1

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	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	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	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

• Sponsor: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Oliver Gunkel, Dr. med., Coordinating Investigator, former PI at the Klinikum Frankfurt (Oder)

Study record dates

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: ICD, CRT-D, lead
• Other Study ID Numbers: TA107