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The purpose of this observational study is to collect data regarding the population of patients implanted with St. Jude Medical ICD.
The purpose of this observational study is to collect data regarding the population of patients implanted with a St. Jude Medical ICD. Data regarding Slow Ventricular Tachycardia Episodes, Atrial Fibrillation Episodes and the devices programmed parameters will be collected during two years after the implant.
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| Measure | Description | Time Frame |
|---|---|---|
| Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec) | Slow Ventricular Tachycardia episodes will be considered as a tachycardia episodes detected by the device between 120-150 bpm and with more than 30sec of duration AF Episodes will be considered only when their duration is >30sec | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients implanted with a St. Jude Medical ICD
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| Name | Affiliation | Role |
|---|---|---|
| Ignacio Fernández Lozano, PhD. | Hospital Universitario Puerta de Hierro | Principal Investigator |
| Javier Alzueta, PhD | Hospital Clinico Universitario Virgen de la Victoria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Puerta de Hierro | Madrid | 28222 | Spain | |||
| Hospital Clínico Universitario Virgen de la Victoria |
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| ID | Title | Description |
|---|---|---|
| FG000 | St Jude Medical ICD/CRT-D | St Jude Medical Implantable Cardioverter Defibrillator (ICD) / Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Device implanted patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All patients
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| ID | Title | Description |
|---|---|---|
| BG000 | St Jude Medical ICD/CRT-D | St Jude Medical ICD/CRT-D Device implanted patients |
| 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 | Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec) | Slow Ventricular Tachycardia episodes will be considered as a tachycardia episodes detected by the device between 120-150 bpm and with more than 30sec of duration AF Episodes will be considered only when their duration is >30sec | 157 patients were analyzed: 118 completed 2 years of Follow Up (FU) and 39 patients were terminated before completing it | Posted | Number | Episodes | 24 months |
|
|
2 years
All Adverse Events (AE) in the study were classified as:
There is not enough information available for a more detailed classification
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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 | St Jude Medical ICD/CRT-D | St Jude Medical ICD/CRT-D Device implanted patients |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious AE | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AE | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ignacio Fernández Lozano | Hospital Clínico Universitario Puerta de Hierro | 913445000 | iflozano@secardiologia.es |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Málaga |
| Spain |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Other reasons |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure | Posted | Number | Patients | 24 months |
|
|
|
| 67 |
| 157 |
| 20 |
| 157 |
| Serious Device related AE | Cardiac disorders | Non-systematic Assessment |
|
| Unspected Serious Device related AE | Cardiac disorders | Non-systematic Assessment |
|
| Device related AE | General disorders | Non-systematic Assessment |
|
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| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |