N/A
Completed N=30
TD01 Master Study (Safety and Efficacy Study)
ICD/CRT-D Indication
Source: ClinicalTrials.gov NCT02087189 ↗
Enrolled (actual)
30
Serious AEs
67.9%
Results posted
Dec 2021
Primary outcomePrimary: TD01 Pacing Threshold — 0.5 V
Summary
This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD lead.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY TD01 Pacing Threshold |
0.5 | — |
| PRIMARY TD01 Sensing Amplitude |
19.6 | — |
| SECONDARY SADE-free Rate Related to TD01 |
96.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT02087189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.