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Master Study of the Acticor/Rivacor ICDs/CRT-Ds and the Plexa ProMRI S DX Lead
NA trial testing Acticor/Rivacor ICDs/CRT-Ds in Heart Failure in 130 participants. Completed in 24 September 2021.
| Lead sponsor | Biotronik SE & Co. KG |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 130 |
| Start date | 30 April 2019 |
| Primary completion | 21 December 2020 |
| Estimated completion | 24 September 2021 |
| Sites | 13 locations across Netherlands, Slovakia, Austria, Germany, Hungary, Switzerland, Latvia |
Biotronik SE & Co. KG — full company profile →
Adults 18 to 99, any sex, with Heart Failure or Tachyarrhythmia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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
| Group | Value | 95% CI |
|---|---|---|
| Acticor/Rivacor ICDs/CRT-Ds | 122 |
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
| Group | Value | 95% CI |
|---|---|---|
| Kaplan-Meier-Estimate for the Cor-Family Related SADE-free Rate 92 Days After Implantation | 99.2 | 94.5 – 99.9 |
| Kaplan-Meier-Estimate for the Cor-Family Related SADE-free Rate 365 Days After Implantation | 99.2 | 94.5 – 99.9 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Acticor/Rivacor ICDs/CRT-Ds | 21 |
| Group | Value | 95% CI |
|---|---|---|
| Acticor/Rivacor ICDs/CRT-Ds | 27 |
| Group | Value | 95% CI |
|---|---|---|
| Acticor/Rivacor ICDs/CRT-Ds | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Acticor/Rivacor ICDs/CRT-Ds | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Acticor/Rivacor ICDs/CRT-Ds | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Acticor/Rivacor ICDs/CRT-Ds | 7 |
| Group | Value | 95% CI |
|---|---|---|
| Acticor/Rivacor ICDs/CRT-Ds | 10 |
| Group | Value | 95% CI |
|---|---|---|
| Acticor/Rivacor ICDs/CRT-Ds | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Acticor/Rivacor ICDs/CRT-Ds | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Acticor/Rivacor ICDs/CRT-Ds | 0 |
Time frame: Patients were followed for 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Acticor/Rivacor ICDs/CRT-Ds |
|---|---|---|
| Cardiac failure | Cardiac disorders | — |
| Adverse drug reaction | General disorders | — |
| Ventricular tachycardia | Cardiac disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Mitral valve incompetence | Cardiac disorders | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Cardiac failure chronic | Cardiac disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Fall | Injury, poisoning and procedural complications | — |
| Implant site haematoma | General disorders | — |
| Procedural pneumothorax | Injury, poisoning and procedural complications | — |
| Pulseless electrical activity | Cardiac disorders | — |
| Syncope | Nervous system disorders | — |
| Acute myocardial infarction | Cardiac disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Ankle fracture | Injury, poisoning and procedural complications | — |
| Aortic intramural haematoma | Vascular disorders | — |
| Aortic valve incompetence | Cardiac disorders | — |
| Ascites | Gastrointestinal disorders | — |
| Atrioventricular block complete | Cardiac disorders | — |
| Barrett's oesophagus | Gastrointestinal disorders | — |
| Blood potassium decreased | Investigations | — |
| Bradycardia | Cardiac disorders | — |
| Cardiac arrest | Cardiac disorders | — |
| Reaction | System | Acticor/Rivacor ICDs/CRT-Ds |
|---|---|---|
| Adverse drug reaction | General disorders | — |
| Implant site haematoma | General disorders | — |
| Device stimulation issue | Product Issues | — |
| Atrial fibrillation | Cardiac disorders | — |
| Chest pain | General disorders | — |
| Condition aggravated | General disorders | — |
| Implant site pain | General disorders | — |
| Renal impairment | Renal and urinary disorders | — |
| Ventricular tachycardia | Cardiac disorders | — |
| Atrial tachycardia | Cardiac disorders | — |
| Blood creatinine increased | Investigations | — |
| Cardiac vein dissection | Injury, poisoning and procedural complications | — |
| Circulatory collapse | Vascular disorders | — |
| Cognitive disorder | Nervous system disorders | — |
| Complication of device insertion | General disorders | — |
| Corona virus infection | Infections and infestations | — |
| Dementia | Nervous system disorders | — |
| Device computer issue | Product Issues | — |
| Device inappropriate shock delivery | Product Issues | — |
| Dizziness | Nervous system disorders | — |
| Electromagnetic interference | Product Issues | — |
| Facet joint syndrome | Musculoskeletal and connective tissue disorders | — |
| Gynaecomastia | Reproductive system and breast disorders | — |
| Hypertension | Vascular disorders | — |
| Hypotension | Vascular disorders | — |
| Hypothyroidism | Endocrine disorders | — |
| Implant site inflammation | General disorders | — |
| Implant site swelling | General disorders | — |
| Large intestinal stenosis | Gastrointestinal disorders | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — |
| Oversensing | Product Issues | — |
| Pericardial effusion | Cardiac disorders | — |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | — |
| Pneumonia | Infections and infestations | — |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | — |
| Post procedural fever | Injury, poisoning and procedural complications | — |
| Radiculopathy | Nervous system disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Sinus tachycardia | Cardiac disorders | — |
| Spinal cord compression | Nervous system disorders | — |
Most-reported serious reactions: Cardiac failure, Adverse drug reaction, Ventricular tachycardia, Atrial fibrillation, Mitral valve incompetence, Pleural effusion, Acute kidney injury, Cardiac failure chronic.
Data from ClinicalTrials.gov NCT03891329 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing