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This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD lead.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD/ CRT-D therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| First ICD/CRT-D implantation or upgrade from pacemaker | Device |
|
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The patients selected for the investigation should be from the investigator's general patient population according to the inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Oliver Gunkel, Dr. med. | Coordinating Investigator, former PI at the Klinikum Frankfurt (Oder) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kepler Universitätsklinikum | Linz | Austria | ||||
| Klinikum Frankfurt (Oder) GmbH |
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| ID | Title | Description |
|---|---|---|
| FG000 | ICD/ CRT-D Therapy With TD01 as ICD Lead | enrolled as a patient planned with ICD and TD01 implantation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
analysis include only the 28 patients that received the TD01 as implant
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| ID | Title | Description |
|---|---|---|
| BG000 | ICD/ CRT-D Therapy With TD01 as ICD Lead | patients with TD01 as implanted ICD lead |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | per protocol analysis | Posted | Median | 95% Confidence Interval | V | 3 month follow-up |
|
|
All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ICD/ CRT-D Therapy With TD01 as ICD Lead | patient with TD01 as implanted ICD lead |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse drug reaction | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mathias Freudigmann, Director Clinical Project Management | BIOTRONIK SE & Co. KG | +49 30 68905 | 1248 | mathias.freudigmann@biotronik.com |
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| 3 month follow-up |
| Frankfurt (Oder) |
| Brandenburg |
| 15236 |
| Germany |
| Vivantes-Krankenhaus Neukölln | Berlin | Germany |
| DRK Krankenhaus Chemnitz-Rabenstein | Chemnitz | Germany |
| Kliniken im Naturpark Altmühltal | Kösching | Germany |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight | Median | Standard Deviation | kg |
|
| Height | Median | Standard Deviation | cm |
|
| Body Mass Index (BMI) | Median | Standard Deviation | kg/m² |
|
| Left Ventricular Ejection Fraction (LVEF) | LVEF is calculated by dividing the volume of blood pumped from the left ventricle per beat (stroke volume) by the volume of blood collected in the left ventricle at the end of diastolic filling (end-diastolic volume). | Median | Standard Deviation | % |
|
| NYHA class | Class I: Ordinary physical activity does not cause undue dyspnea or fatigue. Class II: Comfortable at rest. Ordinary physical activity results in dyspnea or fatigue. Class III: Comfortable at rest. Less than ordinary physical activity results in dyspnea or fatigue. Class IV: Symptoms of heart failure may be present even at rest. If any physical activity is undertaken, discomfort is increased. | Number | participants |
|
| Participants |
|
|
| 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. | per protocol analysis | Posted | Median | 95% Confidence Interval | mV | 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. | full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | 3 month follow-up |
|
|
|
| 6 |
| 28 |
| 19 |
| 28 |
| 0 |
| 28 |
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | Systematic Assessment |
|
| Arteriosclerosis coronary artery | Cardiac disorders | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | Systematic Assessment |
|
| Cataract | Eye disorders | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
|
| Cerebrovascular insufficiency | Nervous system disorders | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Condition aggravated | General disorders | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Device lead damage | Product Issues | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | Systematic Assessment |
|
| Diabetic foot | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | Systematic Assessment |
|
| Duodenal polyp | Gastrointestinal disorders | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | Systematic Assessment |
|
| Implant site haematoma | General disorders | Systematic Assessment |
|
| Inflammation | General disorders | Systematic Assessment |
|
| Lead dislodgement | Product Issues | Systematic Assessment |
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| Melaena | Gastrointestinal disorders | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Oesophageal stenosis | Gastrointestinal disorders | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
|
| Phlebitis | Vascular disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Procedural pneumothorax | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulseless electrical activity | Cardiac disorders | Systematic Assessment |
|
| Rectal polyp | Gastrointestinal disorders | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | Systematic Assessment |
|
| Rhinitis | Infections and infestations | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | Systematic Assessment |
|
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Tonsil cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
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