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The primary purpose of the study is to evaluate if patients with a standard indication for permanent ventricular pacing, left ventricular ejection fraction without limit, or any QRS duration will profit from the prevention of ventricular desynchronisation.
The study will be performed as a controlled, single-blind, international, multicenter, prospective, randomized, parallel group design.
In order to pragmatically examine the effectiveness of biventricular pacing in patients with an indication for ventricular pacing, the study group with biventricular pacing is compared to a control group with standard pacemakers which only allow univentricular (right ventricular) stimulation, as it has been the standard outside of clinical studies until so far.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RV Pacing | Active Comparator | Standard Pacemaker implant |
|
| Biventricular Pacing | Experimental | Biventricular Pacemaker implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biventricular Pacing | Device | Biventricular Pacemaker implant |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Mortality | Number of deaths observed | Study duration (5.7 years mean follow-up) |
| Death or Heart Failure Hospitalization | Number of subjects who experienced death or hospitalization where heart failure is a primary cause of hospitalization | Study duration (5.7 years mean follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Death Due to Cardiovascular Causes | Number of subjects who died due to cardiovascular causes, as classified by the independent Event Adjudication Committee (IEAC) | Study duration (5.7 years mean follow-up) |
| Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test |
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Inclusion Criteria:
Presence of an indication for ventricular pacing according to the actual guidelines for the implantation of cardiac pacemakers and a need for frequent (or even permanent) ventricular pacing for:
Any QRS duration and morphology
Left ventricular ejection fraction (LVEF) without limit as measured by echocardiography (in at least one plane, either 4- or 2-chamber or apical long axis view)
Signed written informed consent of the patient or a first-degree relative for study participation after informing the patient/relative about the risks and the aim of the study
Willingness and ability to comply with the prescribed follow-up tests and schedule of evaluations.
Absence of an implanted ventricular pacing device (patients with atrial pacemakers and new need for ventricular pacing may be included)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reinhard Funck, MD | Klinikum Bad Hersfeld, Germany | Principal Investigator |
| Jean-Jacques Blanc, Prof. | Hôpital Cavale Blanche, Brest, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum der Philipps-Universität Marburg | Marburg | 35033 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16864616 | Background | Funck RC, Blanc JJ, Mueller HH, Schade-Brittinger C, Bailleul C, Maisch B; BioPace Study Group. Biventricular stimulation to prevent cardiac desynchronization: rationale, design, and endpoints of the 'Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization (BioPace)' study. Europace. 2006 Aug;8(8):629-35. doi: 10.1093/europace/eul075. | |
| 24200715 |
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1834 patients have been scheduled for randomization, while 1833 have been randomized to RV Pacing or Biventricular group.
One patient could not be randomized due to organizational reasons.
Patients were enrolled between May 2003 and September 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | RV Pacing | Standard Pacemaker implant RV Pacing: Standard Pacemaker implant |
| FG001 | Biventricular Pacing | Biventricular Pacemaker implant Biventricular Pacing: Biventricular Pacemaker implant |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RV Pacing | Standard Pacemaker implant RV Pacing: Standard Pacemaker implant |
| BG001 | Biventricular Pacing | Biventricular Pacemaker implant Biventricular Pacing: Biventricular Pacemaker implant |
| 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 | Total Mortality | Number of deaths observed | Posted | Count of Participants | Participants | Study duration (5.7 years mean follow-up) |
|
|
Study duration (5.7 years mean follow-up)
The sponsor assessed all events except the death cases without further information, duplicate events and uncomplicated device replacement due to end of life. 5628 events were reviewed and assessed by the sponsor. Subjects may experience more than one adverse event.
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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 | RV Pacing | Standard Pacemaker implant | 307 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | ISO 14155:2011 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | ISO 14155:2011 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pascale Ducloux, Clinical Manager | St Jude Medical | +3227746709 | pducloux@sjm.com |
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| ID | Term |
|---|---|
| D054537 | Atrioventricular Block |
| D018754 | Ventricular Dysfunction |
| ID | Term |
|---|---|
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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| RV Pacing |
| Device |
Standard Pacemaker implant |
|
| 12 months post-implant |
| Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire© | Minnesota Living with Heart Failure (MLWHF) questionnaire score at 12 months MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status. | 12 months post-implant |
| Incidence of Hospitalizations for Deterioration of Heart Failure | Study duration (5.7 years mean follow-up) |
| Incidence of Hospitalizations for Cardiovascular Events | Study duration (5.7 years mean follow-up) |
| Incidence of Hospitalizations for Any Reason | Study duration (5.7 years mean follow-up) |
| Cardiac Structure and Function | 12 & 24 months |
| Successful Implantation of the Left Ventricular Lead | Implantation |
| Chronic Atrial Fibrillation (Defined as Presence of Atrial Fibrillation in Two Subsequent ECG´s/Visits) | Chronic atrial fibrillation is defined as presence of atrial fibrillation in two subsequent ECG´s/visits. | Study duration (5.7 years mean follow-up) |
| Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test | 24 months post-implant |
| Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire© | Minnesota Living with Heart Failure (MLWHF) questionnaire score at 24 months. MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status. | 24 months post-implant |
| Duration of Hospitalizations for Deterioration of Heart Failure | Study Duration (5.7 years mean follow-up) |
| Duration of Hospitalizations for Cardiovascular Events | Study Duration (5.7 years mean follow-up) |
| Duration of Hospitalizations for Any Reason | Study duration (5.7 years mean follow-up) |
| Adverse Events Related to Left Ventricular Lead | Only serious adverse events related to the left ventricular lead are included. | Study Duration (5.7 years mean follow-up) |
| Funck RC, Mueller HH, Lunati M, Piorkowski C, De Roy L, Paul V, Wittenberg M, Wuensch D, Blanc JJ; BioPace study group. Characteristics of a large sample of candidates for permanent ventricular pacing included in the Biventricular Pacing for Atrio-ventricular Block to Prevent Cardiac Desynchronization Study (BioPace). Europace. 2014 Mar;16(3):354-62. doi: 10.1093/europace/eut343. Epub 2013 Nov 7. |
| 40105785 | Derived | Funck RC, Muller HH, Lunati M, De Roy L, Klein N, Meisel E, Milasinovic G, Carlson MD, Wittenberg M, Hindricks G, Blanc JJ. Biventricular vs. right ventricular pacing devices in patients anticipated to require frequent ventricular pacing (BioPace). Europace. 2025 Mar 5;27(3):euaf029. doi: 10.1093/europace/euaf029. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Ventricular pacing at 1 month | Mean | Inter-Quartile Range | % |
|
| Underlying cardiac diseases | Number | participants |
|
| Cardiovascular risk factor | Some participants experienced more than one cardiovascular risk factor. | Number | participants |
|
| Left ventricular ejection fraction (LVEF) | Mean | Standard Deviation | % |
|
| Left Ventricular Ejection Fraction (LVEF) range | Number | participants |
|
| QRS duration | Mean | Standard Deviation | ms |
|
| QRS range | Number | participants |
|
| Atrial arrhythmias | Number | participants |
|
| Left bundle branch block (LBBB) | Number | participants |
|
| Scheduled for ICD | Number | participants |
|
| Indications for device implantation | Number | participants |
|
| Participants |
|
|
|
| Primary | Death or Heart Failure Hospitalization | Number of subjects who experienced death or hospitalization where heart failure is a primary cause of hospitalization | Posted | Count of Participants | Participants | Study duration (5.7 years mean follow-up) |
|
|
|
|
| Secondary | Death Due to Cardiovascular Causes | Number of subjects who died due to cardiovascular causes, as classified by the independent Event Adjudication Committee (IEAC) | Posted | Count of Participants | Participants | Study duration (5.7 years mean follow-up) |
|
|
|
|
| Secondary | Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test | This analysis includes all enrolled patients who completed the 6-minute walk test both at the baseline and 12-month visits. Due to that reason, the overall number of participants analyzed is different from the participant module. | Posted | Mean | Standard Deviation | meters | 12 months post-implant |
|
|
|
| Secondary | Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire© | Minnesota Living with Heart Failure (MLWHF) questionnaire score at 12 months MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status. | This analysis includes all enrolled patients who completed the Minnesota Living With Heart Failure questionnaire both at the baseline and 12-month visits. Due to that reason, the overall number of participants analyzed is different from the participant module. | Posted | Mean | Standard Deviation | score on a scale | 12 months post-implant |
|
|
|
| Secondary | Incidence of Hospitalizations for Deterioration of Heart Failure | Posted | Number | hospitalization per patient year | Study duration (5.7 years mean follow-up) |
|
|
|
| Secondary | Incidence of Hospitalizations for Cardiovascular Events | Posted | Number | hospitalizations per patient year | Study duration (5.7 years mean follow-up) |
|
|
|
| Secondary | Incidence of Hospitalizations for Any Reason | Posted | Number | Hospitalization per patient year | Study duration (5.7 years mean follow-up) |
|
|
|
| Secondary | Cardiac Structure and Function | Data related to cardiac structure and function can not be presented as the data was not collected and analysis provided by the core lab. | Posted | 12 & 24 months |
|
|
| Secondary | Successful Implantation of the Left Ventricular Lead | There was an attempt of left ventricular lead implantation only for subjects from Biventricular Pacing group. | Posted | Number | participants | Implantation |
|
|
|
| Secondary | Chronic Atrial Fibrillation (Defined as Presence of Atrial Fibrillation in Two Subsequent ECG´s/Visits) | Chronic atrial fibrillation is defined as presence of atrial fibrillation in two subsequent ECG´s/visits. | Posted | Number | participants | Study duration (5.7 years mean follow-up) |
|
|
|
| Secondary | Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test | Posted | Mean | Standard Deviation | meters | 24 months post-implant |
|
|
|
| Secondary | Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire© | Minnesota Living with Heart Failure (MLWHF) questionnaire score at 24 months. MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status. | This analysis includes all enrolled patients who completed the Minnesota Living With Heart Failure questionnaire both at the baseline and 24-month visits. Due to that reason, the overall number of participants analyzed is different from the participant module. | Posted | Mean | Standard Deviation | score on a scale | 24 months post-implant |
|
|
|
| Secondary | Duration of Hospitalizations for Deterioration of Heart Failure | Posted | Number | days per patient year | Study Duration (5.7 years mean follow-up) |
|
|
|
| Secondary | Duration of Hospitalizations for Cardiovascular Events | Posted | Number | Days per patient year | Study Duration (5.7 years mean follow-up) |
|
|
|
| Secondary | Duration of Hospitalizations for Any Reason | Posted | Number | days per patient year | Study duration (5.7 years mean follow-up) |
|
|
|
| Secondary | Adverse Events Related to Left Ventricular Lead | Only serious adverse events related to the left ventricular lead are included. | Posted | Number | participants | Study Duration (5.7 years mean follow-up) |
|
|
|
| 908 |
| 641 |
| 908 |
| 451 |
| 908 |
| EG001 | Biventricular Pacing | Biventricular Pacemaker implant | 305 | 902 | 698 | 902 | 507 | 902 |
| Epistaxis | Blood and lymphatic system disorders | ISO 14155:2011 | Systematic Assessment | device pocket revision, lead dysfunction. |
|
| Haemoptysis | Blood and lymphatic system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hematochezia | Blood and lymphatic system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hypercalcemia | Blood and lymphatic system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hyperkalemia | Blood and lymphatic system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hyponatremia | Blood and lymphatic system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Thromboemboli | Blood and lymphatic system disorders | ISO 14155:2011 | Systematic Assessment |
|
| AV Fistula | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Acute Coronary Syndrome | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Angina | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Chest Pain | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Dyspnea | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Endocarditis | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Exacerbation of heart failure | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hypertension | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hypertrophic obstructive cardiomyopathy | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hypotension | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Mitral Regurgitation | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Rise in threshold and exit block | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Shortness of Breath | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Valve damage | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Lowry Wood Syndrome | Congenital, familial and genetic disorders | ISO 14155:2011 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | ISO 14155:2011 | Systematic Assessment |
|
| Diabetes | Endocrine disorders | ISO 14155:2011 | Systematic Assessment |
|
| Glycemia | Endocrine disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hypoglycemia | Endocrine disorders | ISO 14155:2011 | Systematic Assessment |
|
| Cataract | Eye disorders | ISO 14155:2011 | Systematic Assessment |
|
| Galucoma | Eye disorders | ISO 14155:2011 | Systematic Assessment |
|
| Macular Degeneration | Eye disorders | ISO 14155:2011 | Systematic Assessment |
|
| Cholangitis | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Gastrointestinal Bleeding | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Gastrointestinal disease | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Ulcer | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Antral gastritis | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Appendicitis | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Bowel obstruction | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hernia | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Intestinal Obstruction | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Rectal Bleeding | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Dizziness | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Drug Toxicity | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Dysphagia | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Dysphonia | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Esophagitis | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Fever | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hospitalization for non-cardiac diseases | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hydrocephalus | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Influenza | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Lyme Disease | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Malaise | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Pain | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Shingles | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Stenosis | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Syncope | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Weakness | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Worsening of General Patient's Condition | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Cirrhosis | Hepatobiliary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Gallbladder disease | Hepatobiliary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Gallstones | Hepatobiliary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Allergy | Immune system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Infection | Infections and infestations | ISO 14155:2011 | Systematic Assessment |
|
| Sepsis | Infections and infestations | ISO 14155:2011 | Systematic Assessment |
|
| Septic shock | Infections and infestations | ISO 14155:2011 | Systematic Assessment |
|
| Abdominal adhesions post surgery | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Accidental injury | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Acute hemorrhage/bleeding | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Air emboli | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Amputation | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Cardiac or venous perforation | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Cardiac/coronary sinus dissection | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Coronary sinus or cardiac vein thrombosis | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Erosion | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Excessive bleeding | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Extracardiac stimulation (phrenic nerve, diaphragm, chest wall) | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Hematoma/seroma formation | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Medication Error | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Pericardial effusion | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Pericarditis | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Pleural Effusion | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Pneumothorax | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | ISO 14155:2011 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
|
| Bone fracture | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
|
| Coxarthrosis | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
|
| Gout | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
|
| Adenomatous polyps | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ISO 14155:2011 | Systematic Assessment |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ISO 14155:2011 | Systematic Assessment |
|
| Local tissue reaction; formation of fibrotic tissue; cyst formation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ISO 14155:2011 | Systematic Assessment |
|
| Tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ISO 14155:2011 | Systematic Assessment |
|
| Concussion | Nervous system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Delirium | Nervous system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Depression | Nervous system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Dimentia | Nervous system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Orthostatic intolerance | Nervous system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Radicular syndrome | Nervous system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Sclerosis | Nervous system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Sleep Apnea | Nervous system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Inappropriate mode switch | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Inappropriate shocks | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Lead Fracture | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Lead migration, dislodgment or poor lead placement | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Loss of Capture | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Mechanical malfunction of the pacing lead | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Oversensing | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Pacemaker Mediated Tachycardia | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Pacing Lead Impedance Out of Range | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Pulse Generator Reset | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Undersensing | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Altered Mental Status | Psychiatric disorders | ISO 14155:2011 | Systematic Assessment |
|
| Cardiac or venous perforation | Renal and urinary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Kidney Stones | Renal and urinary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Kidney disease | Renal and urinary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Macrohematuria | Renal and urinary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Nephrocalcinosis | Renal and urinary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Renal Disease | Renal and urinary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Ureteral Obstruction | Renal and urinary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Urinary Track Disease | Renal and urinary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Respiratory Disease | Respiratory, thoracic and mediastinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Abscess | Skin and subcutaneous tissue disorders | ISO 14155:2011 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | ISO 14155:2011 | Systematic Assessment |
|
| Colposcopy | Surgical and medical procedures | ISO 14155:2011 | Systematic Assessment |
|
| Coronary artery bypass surgery | Surgical and medical procedures | ISO 14155:2011 | Systematic Assessment |
|
| Endoscopic Retrograde Cholangiopancreatography | Surgical and medical procedures | ISO 14155:2011 | Systematic Assessment |
|
| Iron Infusion | Surgical and medical procedures | ISO 14155:2011 | Systematic Assessment |
|
| Percutaneous Coronary Intervention | Surgical and medical procedures | ISO 14155:2011 | Systematic Assessment |
|
| Planned Lead Revision | Surgical and medical procedures | ISO 14155:2011 | Systematic Assessment |
|
| Planned Pulse Generator Replacement | Surgical and medical procedures | ISO 14155:2011 | Systematic Assessment |
|
| Pulse Generator Pocket Revision | Surgical and medical procedures | ISO 14155:2011 | Systematic Assessment |
|
| Surgery | Surgical and medical procedures | ISO 14155:2011 | Systematic Assessment |
|
| Aneurysm | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Cerebrovascular Accident | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Coronary artery disease | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Fluid accumulation | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Lim Ischemia | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Peripheral Arterial Occlusive Disease | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Peripheral artery disease | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Stroke | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Transient Ischemic Attack | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Venous occlusion | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Bicytopenia | Blood and lymphatic system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Epistaxis | Blood and lymphatic system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hematochezia | Blood and lymphatic system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hypereosinophilia | Blood and lymphatic system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hyperkalemia | Blood and lymphatic system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Thromboemboli | Blood and lymphatic system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Acute Coronary Syndrome | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Arteritis | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Bigeminy | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Chest Pain | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Dyspnea | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Exacerbation of heart failure | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Heart block | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hypertension | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hypotension | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Mitral Regurgitation | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Percutaneous Coronary Intervention | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Rise in threshold and exit block | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Shortness of Breath | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Valve damage | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | ISO 14155:2011 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | ISO 14155:2011 | Systematic Assessment |
|
| Diabetes | Endocrine disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hyperlipidemia | Endocrine disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hypoglycemia | Endocrine disorders | ISO 14155:2011 | Systematic Assessment |
|
| Toxic multinodular goitre | Endocrine disorders | ISO 14155:2011 | Systematic Assessment |
|
| Cataract | Eye disorders | ISO 14155:2011 | Systematic Assessment |
|
| Galucoma | Eye disorders | ISO 14155:2011 | Systematic Assessment |
|
| Macular Degeneration | Eye disorders | ISO 14155:2011 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Ulcer | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Antral gastritis | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hernia | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Ulcerative colitis | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Cold | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Dizziness | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Drug Toxicity | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Dysphonia | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Esophagitis | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Fever | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Genital Prolapse | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hospitalization for non-cardiac diseases | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Influenza | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Pain | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Prolapse | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Shingles | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Short Loss of Consciousness | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Stenosis | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Syncope | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Tremor | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Weakness | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Worsening of General Patient's Condition | General disorders | ISO 14155:2011 | Systematic Assessment |
|
| Dysfibrinogenemia | Hepatobiliary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Gallbladder disease | Hepatobiliary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Gallstones | Hepatobiliary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Allergy | Immune system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Infection | Infections and infestations | ISO 14155:2011 | Systematic Assessment |
|
| Sepsis | Infections and infestations | ISO 14155:2011 | Systematic Assessment |
|
| Accidental injury | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Acute hemorrhage/bleeding | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Air emboli | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Amputation | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Asystole during implant | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Coronary Sinus Cannulation Failure | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Cardiac or venous perforation | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Cardiac tamponade | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Cardiac/coronary sinus dissection | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Coronary sinus or cardiac vein thrombosis | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Erosion | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Excessive bleeding | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Extracardiac stimulation (phrenic nerve, diaphragm, chest wall) | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Hematoma/seroma formation | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Inverted connection of RV and LV Leads | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Pericardial effusion | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Pneumothorax | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Steal Syndrome | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Trauma | Injury, poisoning and procedural complications | ISO 14155:2011 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | ISO 14155:2011 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
|
| Bone fracture | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
|
| Carpal tunnel syndrome | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
|
| Coxarthrosis | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
|
| Gonarthrosis | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
|
| Gout | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hypertonia | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
|
| Tendinitis | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ISO 14155:2011 | Systematic Assessment |
|
| Local tissue reaction; formation of fibrotic tissue; cyst formation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ISO 14155:2011 | Systematic Assessment |
|
| Tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ISO 14155:2011 | Systematic Assessment |
|
| Depression | Nervous system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Facial nerve paralysis | Nervous system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Parethesia | Nervous system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Sleep Apnea | Nervous system disorders | ISO 14155:2011 | Systematic Assessment |
|
| Decreased CRT pacing | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Inability to defibrillate | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Inappropriate mode switch | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Inappropriate shocks | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Lead migration, dislodgment or poor lead placement | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Loss of Capture | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Mechanical malfunction of the pacing lead | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Oversensing | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Pacemaker Mediated Tachycardia | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Pacing Lead Impedance Out of Range | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Pulse Generator Reset | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Undersensing | Product Issues | ISO 14155:2011 | Systematic Assessment |
|
| Elevated uric acid | Renal and urinary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Kidney disease | Renal and urinary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Prostatism | Renal and urinary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Renal Disease | Renal and urinary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Urinary Track Disease | Renal and urinary disorders | ISO 14155:2011 | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Nocturnal desaturation | Respiratory, thoracic and mediastinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Respiratory Disease | Respiratory, thoracic and mediastinal disorders | ISO 14155:2011 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | ISO 14155:2011 | Systematic Assessment |
|
| Mastitis | Skin and subcutaneous tissue disorders | ISO 14155:2011 | Systematic Assessment |
|
| Rosacea on Face | Skin and subcutaneous tissue disorders | ISO 14155:2011 | Systematic Assessment |
|
| Seborrheic keratosis | Skin and subcutaneous tissue disorders | ISO 14155:2011 | Systematic Assessment |
|
| Colposcopy | Surgical and medical procedures | ISO 14155:2011 | Systematic Assessment |
|
| Medication Titration | Surgical and medical procedures | ISO 14155:2011 | Systematic Assessment |
|
| Percutaneous Coronary Intervention | Surgical and medical procedures | ISO 14155:2011 | Systematic Assessment |
|
| Planned Lead Revision | Surgical and medical procedures | ISO 14155:2011 | Systematic Assessment |
|
| Planned Pulse Generator Replacement | Surgical and medical procedures | ISO 14155:2011 | Systematic Assessment |
|
| Pulse Generator Pocket Revision | Surgical and medical procedures | ISO 14155:2011 | Systematic Assessment |
|
| Surgery | Surgical and medical procedures | ISO 14155:2011 | Systematic Assessment |
|
| Aneurysm | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Cerebrovascular Accident | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Coronary artery disease | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Fluid accumulation | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Hemorrhoids | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Lim Ischemia | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Peripheral Arterial Occlusive Disease | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Stroke | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Transient Ischemic Attack | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Varicose Veins | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
| Venous occlusion | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
|
Not provided
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |