Ischemic Heart Disease
Conditions
Brief summary
The objective of the study is to collect information on the naturally occurring variations in ST deviations at different heart rates, as detected by the AnalyST and AnalyST Accel Implantable Cardioverter Defibrillators (ICD).
Interventions
DEVICEICD Implantation
Implantation of a commercially available AnalyST or AnalyST Accel ICD
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has received or is scheduled to receive a St Jude Medical AnalyST or AnalyST Accel ICD; * Patient has documented ischemic heart disease.
Exclusion criteria
* Patient has an indication for ventricular pacing; * Patient has chronotropic incompetence or insufficiency; * Patient has a contraindication to stress testing; * Patient is physically unable to complete the stress test protocol; * The patient has persistent or permanent atrial fibrillation (AF); * Patient is unable to comply with the protocol and follow-up schedule based on geographic location or for any reason; * Patient is pregnant; * Patient is minor (\< 18 years old).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of start and duration of isoelectric PR intervals | 4 weeks |
| Evaluation of start and duration of ST intervals | 4 weeks |
| Evaluation of ST segment deviations during stress testing across the 4 heart rate zones defined by the device | 4 weeks |
| Incidence of ischemic events detected based on the external ECG | 4 weeks |
Countries
Germany
Outcome results
None listed