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Post-Market Clinical Follow-up of the new Cor Family ICDs/CRT-Ds (Acticor, Rivacor) and the new Plexa ProMRI S DX right ventricular lead to provide post-market data and supporting evidence for the clinical safety and performance of the devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acticor/Rivacor ICDs/CRT-Ds | Other | Implant of the new Cor Family internal cardioverter defibrillators (ICDs) / Cardiac Resynchronisation Therapy-Defibrillators (CRT-Ds) and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acticor/Rivacor ICDs/CRT-Ds | Device | pre-defined device programming, measurements and follow-up schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cor Family-related Serious Adverse Device Effect (SADE)-Free Rate Until 3-month Follow-up | Serious Adverse Device Effect (SADE)-free rate possibly or securely related to the Cor Family Internal Cardioverter Defibrillators (ICDs) / Cardiac Resynchronisation Therapy-Defibrillators (CRT-Ds) until 3-month follow-up | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Estimate for the Cor Family Related SADE-free Rate | Application of the Kaplan-Meier method to estimate the 3-month (92 days) SADE-free rate and the 12-month (365 days) SADE-free rate | 3 months, 12 months |
| Number of Handling-Assessments of the Automatic LV VectorOpt Test (CRT-devices Only) by the Investigator |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Steffel, MD | Universitätsspital Zürich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kepler Universitätsklinikum | Linz | Austria | ||||
| Herz- und Diabeteszentrum NRW |
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127 patients received one or more study devices implanted. 3 enrolled patients did not receive a study device. Two of those patients who did not receive a study were excluded from the analysis while the third patient underwent an implantation attempt and was therefore included in the general analysis population
130 patients completed the informed consent process and signed the informed consent sheet.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acticor/Rivacor ICDs/CRT-Ds | Implant of the new Cor Family ICDs and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting Acticor/Rivacor ICDs/CRT-Ds: pre-defined device programming, measurements and follow-up schedule Plexa S DX: Implantation, measurements and follow-up schedule |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 21, 2018 | Nov 18, 2022 |
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| Plexa S DX | Device | Implantation, measurements and follow-up schedule |
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Investigators were asked to assess the overall handling of the Automatic LV VectorOpt test in patients who received a CRT-device. Assessments were collected during implantation, pre-hospital discharge, and 3-month follow-up visit. The following options could be chosen by the investigator: Very good - good - adequate - poor -very poor. |
| 3 months |
| Number of Handling-Assessments for the Overall Handling of the CRT AutoAdapt Feature (CRT-devices Only) by the Investigator | Investigator were asked to assess the overall handling of the CRT AutoAdapt feature in patients who received a CRT-device. Assessments were collected during the 3-month follow-up visit. The following options could be chosen by the investigator: Very good - good - adequate -poor -very poor. | 3 months |
| Bad Oeynhausen |
| Germany |
| Charité Universitätsmedizin Berlin | Berlin | Germany |
| SRH Wald-Klinikum Gera GmbH | Gera | Germany |
| SRH Zentralklinikum Suhl | Suhl | Germany |
| National Hospital of Cardiology | Balatonfüred | Hungary |
| Semmelweis Medical University | Budapest | Hungary |
| Pauls Stradins Clinical University Hospital | Riga | Latvia |
| Hospital Medisch Spectrum Twente | Enschede | Netherlands |
| Erasmus Medical Center | Rotterdam | Netherlands |
| East-Slovak Cardiology Institute (VUSCH) | Košice | Slovakia |
| Inselspital - Universitätsspital Bern | Bern | Switzerland |
| Universitätsspital Zürich | Zurich | Switzerland |
| Patients With Implantation Attempt |
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| Patients Implanted |
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| COMPLETED |
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| NOT COMPLETED |
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Of 130 enrolled patients, 128 underwent an implantation attempt with an investigational device (COR family ICD or Plexa S DC lead) and were included in the baseline analysis population. Two patient received a non-investigational device and were therefore excluded in the baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Acticor/Rivacor ICDs/CRT-Ds | Implant of the new Cor Family ICDs and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting Acticor/Rivacor ICDs/CRT-Ds: pre-defined device programming, measurements and follow-up schedule Plexa S DX: Implantation, measurements and follow-up schedule |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Cor Family-related Serious Adverse Device Effect (SADE)-Free Rate Until 3-month Follow-up | Serious Adverse Device Effect (SADE)-free rate possibly or securely related to the Cor Family Internal Cardioverter Defibrillators (ICDs) / Cardiac Resynchronisation Therapy-Defibrillators (CRT-Ds) until 3-month follow-up | All patients who either had a primary endpoint or who had reached 3 months of follow-up | Posted | Count of Participants | Participants | 3 months |
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| Secondary | Kaplan-Meier Estimate for the Cor Family Related SADE-free Rate | Application of the Kaplan-Meier method to estimate the 3-month (92 days) SADE-free rate and the 12-month (365 days) SADE-free rate | Of 130 enrolled patients, 127 implanted with a COR Family ICD. Out of these, 123 patients were eligible for these endpoint analysis; 4 patients had premature study termination before day 61 after implantation without experiencing a Serious Adverse Device Effect related to the Cor Family device (SADE-d) and were excluded from analysis. For the 12-month endpoint, 111 patients who completed the study were eligible for endpoint analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 3 months, 12 months |
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| Secondary | Number of Handling-Assessments of the Automatic LV VectorOpt Test (CRT-devices Only) by the Investigator | Investigators were asked to assess the overall handling of the Automatic LV VectorOpt test in patients who received a CRT-device. Assessments were collected during implantation, pre-hospital discharge, and 3-month follow-up visit. The following options could be chosen by the investigator: Very good - good - adequate - poor -very poor. | In total, 52 assessments were received from the investigators: 24 assessments at time of implantation, 21 assessments at time of pre-hospital discharge, 7 assessments during 3-month follow-up visit | Posted | Number | Handling-assessment by investigator | 3 months | handling-assessments | handling-assessments |
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| Secondary | Number of Handling-Assessments for the Overall Handling of the CRT AutoAdapt Feature (CRT-devices Only) by the Investigator | Investigator were asked to assess the overall handling of the CRT AutoAdapt feature in patients who received a CRT-device. Assessments were collected during the 3-month follow-up visit. The following options could be chosen by the investigator: Very good - good - adequate -poor -very poor. | In total, 20 assessments were received from the investigator at the time of the 3-month follow-up visit. | Posted | Number | Handling-assessment by investigator | 3 months | handling-assessments | handling-assessments |
|
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Patients were followed for 1 year
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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 | Acticor/Rivacor ICDs/CRT-Ds | Implant of the new Cor Family ICDs and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting Acticor/Rivacor ICDs/CRT-Ds: pre-defined device programming, measurements and follow-up schedule Plexa S DX: Implantation, measurements and follow-up schedule | 5 | 130 | 54 | 130 | 42 | 130 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Adverse drug reaction | General disorders | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Aortic intramural haematoma | Vascular disorders | Systematic Assessment |
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| Aortic valve incompetence | Cardiac disorders | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | Systematic Assessment |
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| Barrett's oesophagus | Gastrointestinal disorders | Systematic Assessment |
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| Blood potassium decreased | Investigations | Systematic Assessment |
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| Bradycardia | Cardiac disorders | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | Systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | Systematic Assessment |
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| Cardiac ventricular thrombosis | Cardiac disorders | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | Systematic Assessment |
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| Cardiorenal syndrome | Cardiac disorders | Systematic Assessment |
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| Cerebral ischaemia | Nervous system disorders | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
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| Chest pain | General disorders | Systematic Assessment |
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| Chronic gastritis | Gastrointestinal disorders | Systematic Assessment |
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| Circulatory collapse | Vascular disorders | Systematic Assessment |
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| Cognitive disorder | Nervous system disorders | Systematic Assessment |
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| Coronary artery occlusion | Cardiac disorders | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Crepitations | General disorders | Systematic Assessment |
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| Death | General disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Delirium | Psychiatric disorders | Systematic Assessment |
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| Device connection issue | Product Issues | Systematic Assessment |
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| Device electrical impedance issue | Product Issues | Systematic Assessment |
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| Device lead damage | Product Issues | Systematic Assessment |
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| Device pacing issue | Product Issues | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Ejection fraction decreased | Investigations | Systematic Assessment |
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| Epilepsy | Nervous system disorders | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Gastric dysplasia | Gastrointestinal disorders | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | Systematic Assessment |
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| General physical health deterioration | General disorders | Systematic Assessment |
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| Haematoma | Vascular disorders | Systematic Assessment |
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| Haemodynamic instability | Vascular disorders | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | Systematic Assessment |
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| Implant site haematoma | General disorders | Systematic Assessment |
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| Implant site haemorrhage | General disorders | Systematic Assessment |
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| Implantation complication | Injury, poisoning and procedural complications | Systematic Assessment |
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| Inflammation | General disorders | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | Systematic Assessment |
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| Klebsiella bacteraemia | Infections and infestations | Systematic Assessment |
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| Lead dislodgement | Product Issues | Systematic Assessment |
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| Mediastinal haematoma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Mitral valve incompetence | Cardiac disorders | Systematic Assessment |
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| Osteoporosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pathological fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Postoperative hypotension | Injury, poisoning and procedural complications | Systematic Assessment |
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| Procedural hypotension | Injury, poisoning and procedural complications | Systematic Assessment |
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| Procedural pneumothorax | Injury, poisoning and procedural complications | Systematic Assessment |
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| Psychomotor skills impaired | Nervous system disorders | Systematic Assessment |
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| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulseless electrical activity | Cardiac disorders | Systematic Assessment |
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| Renal disorder | Renal and urinary disorders | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | Systematic Assessment |
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| Sensing amplitude decreased | Product Issues | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Systematic Assessment |
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| Tricuspid valve incompetence | Cardiac disorders | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Ventricular dyssynchrony | Cardiac disorders | Systematic Assessment |
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| Ventricular fibrillation | Cardiac disorders | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse drug reaction | General disorders | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Atrial tachycardia | Cardiac disorders | Systematic Assessment |
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| Blood creatinine increased | Investigations | Systematic Assessment |
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| Cardiac vein dissection | Injury, poisoning and procedural complications | Systematic Assessment |
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| Chest pain | General disorders | Systematic Assessment |
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| Circulatory collapse | Vascular disorders | Systematic Assessment |
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| Cognitive disorder | Nervous system disorders | Systematic Assessment |
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| Complication of device insertion | General disorders | Systematic Assessment |
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| Condition aggravated | General disorders | Systematic Assessment |
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| Corona virus infection | Infections and infestations | Systematic Assessment |
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| Dementia | Nervous system disorders | Systematic Assessment |
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| Device computer issue | Product Issues | Systematic Assessment |
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| Device inappropriate shock delivery | Product Issues | Systematic Assessment |
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| Device stimulation issue | Product Issues | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Electromagnetic interference | Product Issues | Systematic Assessment |
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| Facet joint syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Gynaecomastia | Reproductive system and breast disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | Systematic Assessment |
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| Implant site haematoma | General disorders | Systematic Assessment |
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| Implant site inflammation | General disorders | Systematic Assessment |
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| Implant site pain | General disorders | Systematic Assessment |
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| Implant site swelling | General disorders | Systematic Assessment |
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| Large intestinal stenosis | Gastrointestinal disorders | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Oversensing | Product Issues | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | Systematic Assessment |
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| Pleurisy | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Post procedural fever | Injury, poisoning and procedural complications | Systematic Assessment |
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| Radiculopathy | Nervous system disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
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| Spinal cord compression | Nervous system disorders | Systematic Assessment |
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| Spinal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Tachyarrhythmia | Cardiac disorders | Systematic Assessment |
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| Undersensing | Product Issues | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Project Management | BIOTRONIK SE & Co.KG | +49 30 68905 | 0 | mathias.freudigmann@biotronik.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 18, 2022 | Nov 18, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Hungary |
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| Slovakia |
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| Switzerland |
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| Germany |
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| handling-assessments |
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| handling-assessments |
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