TD01 Master Study (Safety and Efficacy Study)

N/ACompletedNCT02087189

Biotronik SE & Co. KG30 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

ICD/CRT-D Indication

Interventions

First ICD/CRT-D implantation or upgrade from pacemakerDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Kepler Universitätsklinikum

Linz, Austria

Klinikum Frankfurt (Oder) GmbH

Frankfurt (Oder), Brandenburg, Germany

Vivantes-Krankenhaus Neukölln

Berlin, Germany

DRK Krankenhaus Chemnitz-Rabenstein

Chemnitz, Germany

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 3 month follow-up

Secondary Outcomes

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.

Time frame: 3 month follow-up

Data from ClinicalTrials.gov

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