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| Name | Class |
|---|---|
| Biotronik SE & Co. KG | INDUSTRY |
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The goal of this exploratory study is to test the preliminary safety and product performance of the new Amvia/Solvia pacemaker family in subjects that require a pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation. The study will be conducted at sites in Australia and New Zealand. It is planned to include 50 subjects in the study. Participants will visit sites at enrollment in the study, at implantation, pre-hospital discharge, 1- 3- and 12-month follow-up visits. At the visits the device will be interrogated and standard device measurements including those related to special features will be performed to assess the functionality of the device. Programming of the pacemakers will be done according to the participant´s therapeutical needs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amvia Sky pacemaker or CRT-P implantation | Experimental | Patients implanted with an Amvia Sky pacemaker or CRT-P device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amvia Sky pacemaker or CRT-P device | Device | Subjects with an indication for a pacemaker or CRT-P device will be implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. Device programming will be done according to the medical needs of the subjects. |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Device Effect (SADE)-Free Rate After 12 Months | Descriptive statistics of the investigational device related SADE-free rate after first implantation attempt will be calculated using a Kaplan-Meier estimate | 12 months |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Right Atrial Sensing Amplitude | The sensing amplitude is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum voltage of the heart's intrinsic electrical signals that a pacemaker can detect through its leads to monitor the heart's natural activity and decide whether pacing is needed. In this case refering to the lead placed in the right atrium. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin Mariani, Dr | The Alfred | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Hunter Hospital | New Lambton Heights | New South Wales | 2305 | Australia | ||
| Advara Heart Care Wesley |
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50 patients were planned to be enrolled according to the protocol. At the time of the notification of enrollment stop (after the 50th implantation), two additional patients were already enrolled, thus leading to a total of 52 enrolled patients.
All enrolled patients provided written informed consent and were implanted with an investigational device.
52 patients were enrolled between the date of first patient in (November 23, 2022) and last patient in (May 25, 2023).
Patients that were already enrolled at the time of the notification of enrollment stop (after the 50th implantation) were still admitted for implantation, thus leading to two more patients than specified in the protocol (N=50)l.
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| ID | Title | Description |
|---|---|---|
| FG000 | Amvia Sky Pacemaker or CRT-P Implantation | Patients implanted with an Amvia Sky pacemaker or CRT-P device Amvia Sky pacemaker or CRT-P device: Subjects with an indication for a pacemaker or CRT-P device were implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. After implantation with an investigational device, the patients were seen by the investigator at pre-hospital discharge, 1-month, 3-months, and 12-months follow-up. All clinical procedures were performed according to clinical routine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Amvia Sky Pacemaker or CRT-P Implantation | Patients implanted with an Amvia Sky pacemaker or CRT-P device Amvia Sky pacemaker or CRT-P device: Subjects with an indication for a pacemaker or CRT-P device were implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. After implantation with an investigational device, the patients were seen by the investigator at pre-hospital discharge, 1-month, 3-months, and 12-months follow-up. All clinical procedures were performed according to clinical routine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Serious Adverse Device Effect (SADE)-Free Rate After 12 Months | Descriptive statistics of the investigational device related SADE-free rate after first implantation attempt will be calculated using a Kaplan-Meier estimate | All 52 patients implanted with an investigational device contribute to the analysis of the SADE-free rate. Neither any of the 46 patients with regular study termination after 12 months, nor any of the 6 patients with premature study termination had any SADE. Thus, a 95% CI for the SADE-free rate could methodologically not be estimated with the Kaplan-Meier method, but instead with the binomial method. | Posted | Count of Participants | Participants | 12 months |
|
Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one 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 | Amvia Sky Pacemaker or CRT-P Implantation | Patients implanted with an Amvia Sky pacemaker or CRT-P device Amvia Sky pacemaker or CRT-P device: Subjects with an indication for a pacemaker or CRT-P device were implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. After implantation with an investigational device, the patients were seen by the investigator at pre-hospital discharge, 1-month, 3-months, and 12-months follow-up. All clinical procedures were performed according to clinical routine. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device computer issue | Product Issues | MedDRA 22.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Project Management | BIOTRONIK SE & Co. KG | +49 30 68905 | 0 | mathias.freudigmann@biotronik.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: sections 1-9 | May 30, 2022 | Apr 17, 2025 | Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: sections 10-23 | May 30, 2022 | Apr 17, 2025 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Amendments | Mar 13, 2023 | Apr 17, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 17, 2023 | Mar 27, 2025 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D001919 | Bradycardia |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| 12 months |
| Right Atrial Pacing Threshold | The pacing threshold is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum amount of electrical energy required to consistently depolarize the myocardium, thereby triggering a cardiac contraction. In this case refering to the lead placed in the right atrium. | 12 months |
| Right Ventricular Sensing Amplitude | The sensing amplitude is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum voltage of the heart's intrinsic electrical signals that a pacemaker can detect through its leads to monitor the heart's natural activity and decide whether pacing is needed. In this case refering to the lead placed in the right ventricle. | 12 months |
| Right Ventricular Pacing Threshold | The pacing threshold is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum amount of electrical energy required to consistently depolarize the myocardium, thereby triggering a cardiac contraction. In this case refering to the lead placed in the right ventricle. | 12 months |
| Left Ventricular Sensing Amplitude | The sensing amplitude is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum voltage of the heart's intrinsic electrical signals that a pacemaker can detect through its leads to monitor the heart's natural activity and decide whether pacing is needed. In this case refering to the lead placed next to the left ventricle. | 12 months |
| Left Ventricular Pacing Threshold | The pacing threshold is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum amount of electrical energy required to consistently depolarize the myocardium, thereby triggering a cardiac contraction. In this case refering to the lead placed next to the left ventricle. | 12 months |
| Auchenflower |
| Queensland |
| 4066 |
| Australia |
| Gold Coast University Hospital | Southport | Queensland | 4215 | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | 7001 | Australia |
| Peninsula Heart Centre | Frankston | Victoria | 3199 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Christchurch Hospital | Christchurch | 8140 | New Zealand |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Other Pre-specified | Right Atrial Sensing Amplitude | The sensing amplitude is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum voltage of the heart's intrinsic electrical signals that a pacemaker can detect through its leads to monitor the heart's natural activity and decide whether pacing is needed. In this case refering to the lead placed in the right atrium. | The analysis population for right atrial lead parameters consists of those patients that were implanted with an atrial lead, i.e. patients with a dual- or triple-chamber device, and for whom a value was measured at the specified timepoint. | Posted | Mean | Standard Deviation | mV | 12 months |
|
|
|
| Other Pre-specified | Right Atrial Pacing Threshold | The pacing threshold is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum amount of electrical energy required to consistently depolarize the myocardium, thereby triggering a cardiac contraction. In this case refering to the lead placed in the right atrium. | The analysis population for right atrial lead parameters consists of those patients that were implanted with an atrial lead, i.e. patients with a dual- or triple-chamber device, and for whom a value was measured at the specified timepoint. | Posted | Mean | Standard Deviation | V | 12 months |
|
|
|
| Other Pre-specified | Right Ventricular Sensing Amplitude | The sensing amplitude is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum voltage of the heart's intrinsic electrical signals that a pacemaker can detect through its leads to monitor the heart's natural activity and decide whether pacing is needed. In this case refering to the lead placed in the right ventricle. | The analysis population for right ventricular lead parameters consists of all patients for whom a value was measured at the specified timepoint. | Posted | Mean | Standard Deviation | mV | 12 months |
|
|
|
| Other Pre-specified | Right Ventricular Pacing Threshold | The pacing threshold is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum amount of electrical energy required to consistently depolarize the myocardium, thereby triggering a cardiac contraction. In this case refering to the lead placed in the right ventricle. | The analysis population for right ventricular lead parameters consists of all patients for whom a value was measured at the specified timepoint. | Posted | Mean | Standard Deviation | V | 12 months |
|
|
|
| Other Pre-specified | Left Ventricular Sensing Amplitude | The sensing amplitude is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum voltage of the heart's intrinsic electrical signals that a pacemaker can detect through its leads to monitor the heart's natural activity and decide whether pacing is needed. In this case refering to the lead placed next to the left ventricle. | The analysis population for left ventricular lead parameters consists of those patients that were implanted with an LV lead, i.e. patients with a triple-chamber device, and for whom a value was measured at the specified timepoint. | Posted | Mean | Standard Deviation | mV | 12 months |
|
|
|
| Other Pre-specified | Left Ventricular Pacing Threshold | The pacing threshold is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum amount of electrical energy required to consistently depolarize the myocardium, thereby triggering a cardiac contraction. In this case refering to the lead placed next to the left ventricle. | The analysis population for left ventricular lead parameters consists of those patients that were implanted with an LV lead, i.e. patients with a triple-chamber device, and for whom a value was measured at the specified timepoint. | Posted | Mean | Standard Deviation | V | 12 months |
|
|
|
| 6 |
| 52 |
| 30 |
| 52 |
| 27 |
| 52 |
| Adverse drug reaction | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Procedural pneumothorax | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Accelerated idioventricular rhythm | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Adnexa uteri mass | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Central nervous system lesion | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dementia Alzheimer's type | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Enterobacter pneumonia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Escherichia urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Gastrooesophageal cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
|
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Herpes simplex encephalitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Herpes simplex meningoencephalitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Iliac artery perforation | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Implant site erythema | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Implant site pain | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Implant site swelling | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Implant site warmth | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Inflammatory marker increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Intestinal mass | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Lead dislodgement | Product Issues | MedDRA 22.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Morganella infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Nerve injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pemphigoid | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pneumonia moraxella | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Tricuspid valve incompetence | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Urinary tract infection bacterial | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Vestibular neuronitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Corona virus infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Device stimulation issue | Product Issues | MedDRA 22.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Back injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Bundle branch block left | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cardiac sarcoidosis | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Device programming error | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Gastrointestinal stoma output abnormal | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Implant site haematoma | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Implant site pain | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Implant site paraesthesia | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Implant site swelling | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Peripheral coldness | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Raynaud's phenomenon | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Sarcoidosis | Immune system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
|
| Skin candida | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Tongue injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Undersensing | Product Issues | MedDRA 22.1 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 22.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |