ICD/CRT-D Indication
Conditions
Keywords
ICD, CRT-D, lead
Brief summary
This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD lead.
Interventions
DEVICEFirst ICD/CRT-D implantation or upgrade from pacemaker
Sponsors
Biotronik SE & Co. KG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TD01 Pacing Threshold | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| SADE-free Rate Related to TD01 | 3 month follow-up | 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. |
Countries
Austria, Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ICD/ CRT-D Therapy With TD01 as ICD Lead patients with TD01 as implanted ICD lead | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | enrolled but did not receive a TD01 as implant | 2 |
Baseline characteristics
| Characteristic | ICD/ CRT-D Therapy With TD01 as ICD Lead |
|---|---|
| Age, Continuous | 70.7 years STANDARD_DEVIATION 8.9 |
| Body Mass Index (BMI) | 28.5 kg/m² STANDARD_DEVIATION 5.1 |
| Height | 172.0 cm STANDARD_DEVIATION 8.2 |
| Left Ventricular Ejection Fraction (LVEF) | 30 % STANDARD_DEVIATION 12.7 |
| NYHA class NYHA class I | 2 participants |
| NYHA class NYHA class II | 11 participants |
| NYHA class NYHA class III | 15 participants |
| NYHA class NYHA class IV | 0 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 21 Participants |
| Weight | 84.5 kg STANDARD_DEVIATION 19.8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 19 / 28 |
Outcome results
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.
Time frame: 3 month follow-up
Population: per protocol analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ICD/ CRT-D Therapy With TD01 as ICD Lead | TD01 Pacing Threshold | 0.5 V |
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.
Time frame: 3 month follow-up
Population: per protocol analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ICD/ CRT-D Therapy With TD01 as ICD Lead | TD01 Sensing Amplitude | 19.6 mV |
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.
Time frame: 3 month follow-up
Population: full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ICD/ CRT-D Therapy With TD01 as ICD Lead | SADE-free Rate Related to TD01 | 96.4 percentage of participants |