TD01 Master Study (Safety and Efficacy Study)

ICD/CRT-D Indication Clinical Trial

Official title:

TD01 Master Study (Safety and Efficacy Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02087189
• Other study ID #: TA107
• Status: Completed
• Start date: August 2014
• Est. completion date: March 31, 2020

Study information

• Verified date: January 2020
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 31, 2020
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ICD/CRT-D Indication

Intervention

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

Locations

Country	Name	City	State
Austria	Kepler Universitätsklinikum	Linz
Germany	Vivantes-Krankenhaus Neukölln	Berlin
Germany	DRK Krankenhaus Chemnitz-Rabenstein	Chemnitz
Germany	Klinikum Frankfurt (Oder) GmbH	Frankfurt (Oder)	Brandenburg
Germany	Kliniken im Naturpark Altmühltal	Kösching

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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