TD01 Master Study (Safety and Efficacy Study)

Completed

• Conditions: ICD/CRT-D Indication
• Interventions: Device: First ICD/CRT-D implantation or upgrade from pacemaker

• Registration Number: NCT02087189
• Lead Sponsor: Biotronik SE & Co. KG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-14
• Study Start: 2014-08
• Primary Completion: 2015-12
• Status Verified: 2020-01
• Study Completion: 2020-03-31
• Results First Submitted: 2021-06-14
• Results First Submitted QC: 2021-10-27
• Last Update Submitted: 2021-10-27
• Results First Posted: 2021-12-03
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICD/ CRT-D therapy	First ICD/CRT-D implantation or upgrade from pacemaker	-

Primary Outcome Measures

Name	Time	Method
TD01 Pacing Threshold	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	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 Outcome Measures

Name	Time	Method
SADE-free Rate Related to TD01	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.

Trial Locations

Locations (5)

Kepler Universitätsklinikum; 🇦🇹 Linz, Austria

Klinikum Frankfurt (Oder) GmbH; 🇩🇪 Frankfurt (Oder), Brandenburg, Germany

DRK Krankenhaus Chemnitz-Rabenstein; 🇩🇪 Chemnitz, Germany

Kliniken im Naturpark Altmühltal; 🇩🇪 Kösching, Germany

Vivantes-Krankenhaus Neukölln; 🇩🇪 Berlin, Germany