TD01 Master Study (Safety and Efficacy Study)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- ICD/CRT-D Indication
- Sponsor
- Biotronik SE & Co. KG
- Enrollment
- 30
- Locations
- 5
- Primary Endpoint
- TD01 Pacing Threshold
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD lead.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
TD01 Pacing Threshold
Time Frame: 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
Time Frame: 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 Outcomes
- SADE-free Rate Related to TD01(3 month follow-up)