TD01 Master Study (Safety and Efficacy Study)

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

Official Title
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TD01 Master Study (Safety and Efficacy Study)

Conditions
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ICD/CRT-D Indication

Intervention / Treatment
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* Device: First ICD/CRT-D implantation or upgrade from pacemaker


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICD/ CRT-D therapy<br> | Device: First ICD/CRT-D implantation or upgrade from pacemaker<br> <br> * Other names: Free choice of additional RA and/or LV lead (if applicable);|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICD, CRT-D, lead