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To prospectively evaluate if the analysis of genetic polymorphisms can be used to identify patients at risk of ventricular tachycardia.
To evaluate the influence of ICD-based diagnostic information on the long term treatment and management of primary prevention ICD-patients.
Evaluate the positive predictive value of single nucleotide polymorphisms (SNPs) in the genes GNB3, GNAS and GNAQ as predictors of ventricular arrhythmia <400 msec.
Evaluate the positive predictive value of Single Nucleotide Polymorphisms as predictor for death, cardiac death and atrial fibrillation/flutter in the genes GNB3, GNAS, GNAQ and other SNPs involving signal transduction components which impact on the activity of cardiac ion channels.
Evaluate the best combination of genetic parameters, baseline data and follow-up data as predictor of primary endpoint, All cause Mortality, cardiac death and atrial arrhythmia.
Evaluate the usage of ICD-system diagnostics (battery status, impedance, pacing threshold, sensing) resulting in medical consequences*.
Evaluate the usage of ICD-based patient diagnostics (arrhythmia, IEGM, heart frequency, %pacing, Cardiac Compass) resulting in medical consequences*.
Evaluate the frequency of programming changes involving AF-prevention and AF-therapy algorithms.
Evaluate the frequency of pacing-parameter programming changes and the resulting medical consequences*.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD Therapy, blood sampling | Experimental | Blood sampling Defibrillator, Dual Chamber ; Implantable |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Defibrillator, Dual Chamber ; Implantable | Device | Patient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.393C>T Genotype | The GNAS c.393C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype. | 2 years |
| Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.2273C>T Genotype | The GNAS c.2273C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype. | 2 years |
| Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.2291C>T Genotype | The GNAS c.2291C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype. | 2 years |
| Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-909/-908GC>TT Genotype | The GNAQ c.-909/-908GC>TT single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype. | 2 years |
| Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-382G>A Genotype |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization, Medical Interventions, Medication, Surgery, Additional Diagnostics | 2 years | |
| All Cause Mortality, Cardiac Death and Atrial Fibrillation/Flutter | 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Women who are pregnant, or women of childbearing potential not on a reliable form of birth control,
Subject is enrolled in a concurrent study that may confound the results of this study,
Subject has a life expectancy less than two years,
Subject is post heart transplant or awaiting heart transplantation,
Subject is anticipated to demonstrate poor compliance,
Subjects with syndromes known to be associated with ion channel pathologies such as:
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| Name | Affiliation | Role |
|---|---|---|
| Domenico Corrado, MD | University of Padova, Italy | Principal Investigator |
| Heiner Wieneke, MD | Universitätsklinikum Essen, Germany | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27895044 | Derived | Wieneke H, Svendsen JH, Lande J, Spencker S, Martinez JG, Strohmer B, Toivonen L, Le Marec H, Garcia-Fernandez FJ, Corrado D, Huertas-Vazquez A, Uy-Evanado A, Rusinaru C, Reinier K, Foldesi C, Hulak W, Chugh SS, Siffert W. Polymorphisms in the GNAS Gene as Predictors of Ventricular Tachyarrhythmias and Sudden Cardiac Death: Results From the DISCOVERY Trial and Oregon Sudden Unexpected Death Study. J Am Heart Assoc. 2016 Nov 28;5(12):e003905. doi: 10.1161/JAHA.116.003905. |
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study is closed several years ago; this is not applicable for this study
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| ID | Title | Description |
|---|---|---|
| FG000 | ICD Therapy, Blood Sampling | Defibrillator, Dual Chamber ; Implantable: Patient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes. Blood sampling: Blood sampling for genetic analysis of the pre-identified SNPs |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ICD Therapy, Blood Sampling | Defibrillator, Dual Chamber ; Implantable: Patient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes. Blood sampling: Blood sampling for genetic analysis on pre-specified SNPs |
| 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 | Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.393C>T Genotype | The GNAS c.393C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype. | Posted | Number | participants with VT < 400 msec | 2 years |
|
From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs
Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported.
Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ICD Therapy, Blood Sampling | Defibrillator, Dual Chamber ; Implantable: Patient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes. Blood sampling: Blood sampling for genetic analysis on pre-identified SNPs |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site pain | General disorders | MedDRA (20.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abscess | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
The following limitations can be noted:
• Patient follow-up was prematurely terminated after at least 12-month follow-up data on all enrolled patients but before the planned 24-month follow-up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margriet Kruijshoop, Clinical Research Manager | Medtronic BRC | +31623910708 | margriet.kruijshoop@medtronic.com |
| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| D014693 | Ventricular Fibrillation |
| D013610 | Tachycardia |
| D001281 | Atrial Fibrillation |
| D012804 | Sick Sinus Syndrome |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
Not provided
Not provided
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D013048 | Specimen Handling |
Not provided
Not provided
Not provided
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Not provided
patients and investigators were blinded to the genetic markers during the study. Therefore, no arm is specified as this is not applicable.
| Blood sampling | Procedure | Blood sampling |
|
The GNAQ c.-382G>A single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype. |
| 2 years |
| Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-387G>A Genotype | The GNAQ c.-387G>A single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype. | 2 years |
| Outcome Measure Title: Number of Patients With Ventricular Arrhythmia <400 Msec. by GNB3 c.825C>T Genotype | The GNB3 c.825C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype. | 2 years |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Measures are completed for total enrolled population, including those with inadequate data for analysis. | Number | participants |
|
Patients in this group have one copy of each allele (C and T) for the c.393C>T single nucleotide polymorphism (SNP) in the GNAS gene
| OG002 | c.393C>T TT Genotype | Patients in this group have two copies of the minor (T) allele for the c.393C>T single nucleotide polymorphism (SNP) in the GNAS gene |
|
|
| Secondary | Hospitalization, Medical Interventions, Medication, Surgery, Additional Diagnostics | Not Posted | 2 years | Participants |
| Secondary | All Cause Mortality, Cardiac Death and Atrial Fibrillation/Flutter | Not Posted | 2 years | Participants |
| Primary | Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.2273C>T Genotype | The GNAS c.2273C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype. | Posted | Number | participants with VT < 400 msec | 2 years |
|
|
|
| Primary | Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.2291C>T Genotype | The GNAS c.2291C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype. | Posted | Number | participants with VT < 400 msec | 2 years |
|
|
|
| Primary | Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-909/-908GC>TT Genotype | The GNAQ c.-909/-908GC>TT single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype. | Posted | Number | participants with VT < 400 msec | 2 years |
|
|
|
| Primary | Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-382G>A Genotype | The GNAQ c.-382G>A single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype. | Posted | Number | participants with VT < 400 msec | 2 years |
|
|
|
| Primary | Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-387G>A Genotype | The GNAQ c.-387G>A single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype. | Posted | Number | participants with VT < 400 msec | 2 years |
|
|
|
| Primary | Outcome Measure Title: Number of Patients With Ventricular Arrhythmia <400 Msec. by GNB3 c.825C>T Genotype | The GNB3 c.825C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype. | Posted | Number | participants with VT < 400 msec | 2 years |
|
|
|
| 265 |
| 1,145 |
| 45 |
| 1,145 |
| Abdominal operation | Surgical and medical procedures | MedDRA (20.0) | Non-systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| aneamia | Blood and lymphatic system disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| angina pectoris | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| aortic aneurysm | Vascular disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| arrhythmia | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| arrhythmia supraventricular | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| arteriogram coronary | Investigations | MedDRA (20.0) | Non-systematic Assessment |
|
| asthenia | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| atrial flutter | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| atrial tachycardia | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| bile duct stone | Hepatobiliary disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| bradyarrhythmia | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| cardiac ablation | Surgical and medical procedures | MedDRA (20.0) | Non-systematic Assessment |
|
| cardiac failure | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| cardiac failure acute | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| cardiac failure chronic | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| cardiac tamponade | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| cardiogenic shock | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| cardioversion | Surgical and medical procedures | MedDRA (20.0) | Non-systematic Assessment |
|
| cerebellar stroke | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| cerebral infarction | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| cerebrovascular accident | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
|
| chest discomfort | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| chest pain | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| circulatory collapse | Vascular disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Non-systematic Assessment |
|
| Complication associated with device | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| cororary artery disease | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| death | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| deep venous thrombosis | Vascular disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| dehydration | Metabolism and nutrition disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| device dislocation | Product Issues | MedDRA (20.0) | Non-systematic Assessment |
|
| Device electrical impedance issue | Product Issues | MedDRA (20.0) | Non-systematic Assessment |
|
| device extrusion | Product Issues | MedDRA (20.0) | Non-systematic Assessment |
|
| device issue | Product Issues | MedDRA (20.0) | Non-systematic Assessment |
|
| device lead damage | Product Issues | MedDRA (20.0) | Non-systematic Assessment |
|
| device lead issue | Product Issues | MedDRA (20.0) | Non-systematic Assessment |
|
| device malfunction | Product Issues | MedDRA (20.0) | Non-systematic Assessment |
|
| device pacing issue | Product Issues | MedDRA (20.0) | Non-systematic Assessment |
|
| device related infection | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| device stimulation issue | Product Issues | MedDRA (20.0) | Non-systematic Assessment |
|
| dizziness | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| gastrointestinal uler haemorrhage | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| gout | Metabolism and nutrition disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| haematoma | Vascular disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| haemorrhage | Vascular disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| heart failure | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| hospitalisation | Surgical and medical procedures | MedDRA (20.0) | Non-systematic Assessment |
|
| hypertension | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| hypertensive nephropathy | Renal and urinary disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| hyperthyroidism | Endocrine disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| ill-defined disorder | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| implant site haematoma | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| implant site infection | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
|
| implant site infection | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| implant site swelling | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| implant site ulcer | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| inflammatory marker increased | Investigations | MedDRA (20.0) | Non-systematic Assessment |
|
| invertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| ischaemic cardiomayopathy | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| ischaemic stroke | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| lead dislodgement | Product Issues | MedDRA (20.0) | Non-systematic Assessment |
|
| lung infection | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| medical device site abscess | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Medical device site extravasation | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| multiple injuries | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| myocardial infarction | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| opthalmic herpes simplex | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| orthopnea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| ovarian cyst | Reproductive system and breast disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| oversensing | Product Issues | MedDRA (20.0) | Non-systematic Assessment |
|
| Pacemaker generated arrhythmia | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| pain | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| palpitations | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| paroxysmal arrhythmia | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Peripheral artery stent insertion | Surgical and medical procedures | MedDRA (20.0) | Non-systematic Assessment |
|
| peripheral artery thrombosis | Vascular disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| pneumonia | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| pocket erosion | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
|
| presyncope | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| renal failure | Renal and urinary disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| silent myocardial infarction | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Non-systematic Assessment |
|
| stent placement | Surgical and medical procedures | MedDRA (20.0) | Non-systematic Assessment |
|
| supraventricular extrasystoles | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| therapy non-responder | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| thrombosis | Vascular disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| transient global amnesia | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| traumatic haemothorax | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
|
| undersensing | Product Issues | MedDRA (20.0) | Non-systematic Assessment |
|
| urinary tract infection bacterial | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| vena cava thrombosis | Vascular disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| ventricular arrhythmia | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| ventricular fibrillation | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| ventricular tachycardia | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| wound necrosis | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
|
| acute coronary syndrome | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| acute haemorrhagic ulcerative colitis | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| cardiac death | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| cardiac failure | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| cardiac failure acute | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| cardiac tamponade | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| carpal tunnel syndrome | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| cerebrovascular accident | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| chest pain | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| depression | Psychiatric disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| device extrusion | Product Issues | MedDRA (20.0) | Non-systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| dizziness | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
|
| hospitalisation | Surgical and medical procedures | MedDRA (20.0) | Non-systematic Assessment |
|
| hypertensive emergency | Vascular disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| hypotension | Vascular disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| implant site haematoma | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| implant site infection | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
|
| implant site infection | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| implant site pain | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| malaise | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Medical device site haematoma | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| pneumonia | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| presyncope | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| sciatica | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| sepsis | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| sinus tachycardia | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| supraventricular tachycardia | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| ventricular tachycardia | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| wound secretion | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
|
Not provided
| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000075224 | Cardiac Conduction System Disease |
| D001146 | Arrhythmia, Sinus |
| D006327 | Heart Block |
| D019411 |
| Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |