Atrial Fibrillation, Ventricular Tachycardia
Conditions
Brief summary
The purpose of this observational study is to collect data regarding the population of patients implanted with St. Jude Medical ICD.
Detailed description
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.
Interventions
None listed
Sponsors
Abbott Medical Devices
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has been implanted with a St Jude Medical ICD, mono,bicameral or cardiac resynchronization therapy - Defibrillator (CRT-D) according the American College of Cardiology (ACC), American Heart Association (AHA), National Standards for Physical Education (NASPE) guidelines. (min. 24 hours - max. 2 months) * Patient has signed the study specific Informed consent document. * Patient is older than 18 years of age
Exclusion criteria
* Patient has a permanent Atrial Fibrillation * Patient has a documented slow ventricular Tachycardia Episodes previous to the ICD implant. * Patient not programed with a ventricular Tachycardia (VT) zone upper than 120 bpm. * Patient requires cardiac resynchronization * Patient has Brugada Syndrome * Patient has long QT Syndrome * Patient has a device replacement; * Patient is pregnant or nursing * Patient is unable to attend the follow-up visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec) | 24 months | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure | 24 months |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| St Jude Medical ICD/CRT-D St Jude Medical ICD/CRT-D Device implanted patients | 157 |
| Total | 157 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 5 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Other reasons | 14 |
| Overall Study | Physician Decision | 4 |
| Overall Study | Protocol Violation | 6 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | St Jude Medical ICD/CRT-D |
|---|---|
| Age, Continuous | 61.67 years STANDARD_DEVIATION 13.39 |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 157 |
| serious Total, serious adverse events | 67 / 157 |
Outcome results
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
Time frame: 24 months
Population: 157 patients were analyzed: 118 completed 2 years of Follow Up (FU) and 39 patients were terminated before completing it
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| St Jude Medical ICD/CRT-D | Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec) | Device Slow VT Episodes | 3778 Episodes |
| St Jude Medical ICD/CRT-D | Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec) | Internal Investigator Slow VT Episodes | 112 Episodes |
| St Jude Medical ICD/CRT-D | Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec) | External investigator Slow VT Episodes | 68 Episodes |
| St Jude Medical ICD/CRT-D | Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec) | Device AF>30sec Episodes | 308 Episodes |
| St Jude Medical ICD/CRT-D | Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec) | Internal Investigator AF>30sec Episodes | 1900 Episodes |
| St Jude Medical ICD/CRT-D | Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec) | External Investigator AF>30sec Episodes | 2864 Episodes |
Secondary
Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure
Time frame: 24 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| St Jude Medical ICD/CRT-D | Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure | Cardiovascular Mortality | 5 Patients |
| St Jude Medical ICD/CRT-D | Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure | Hospitalization due to cardiovascular reasons | 31 Patients |