Coronary Artery Disease
Conditions
Keywords
ICD Indicated patients, documented CAD
Brief summary
This is a prospective, non-randomized, multicenter, pivotal Investigational Device Exemption (IDE) study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in St Jude Medical ICD systems.
Detailed description
This is a prospective, non-randomized, multicenter, pivotal IDE study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in the Fortify® ST, Fortify Assura® ST, and Ellipse® ST family of devices, as well as any future St Jude Medical devices with the same ST Monitoring Feature capabilities. Effectiveness of the device will be evaluated by analyzing the sensitivity of the ST Monitoring Feature to detect clinical events. In addition, safety of the ST Monitoring Feature will be evaluated by demonstrating a low percentage of patients with false positive events.
Interventions
DEVICEFortify® ST, Fortify Assura® ST, Ellipse® ST family of devices
Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
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
* Eligible patients will meet all of the following: 1. Have an indication for an ICD implantation or pulse generator change 2. Have documented coronary artery disease. Documented coronary artery disease is defined as having at least one of the following present a) evidence of a prior MI on ECG and/or cardiac enzymes, b) prior revascularization (by coronary artery bypass grafting or percutaneous coronary intervention) c) angina and/or ST-T wave abnormalities indicative of ischemia on exercise stress test, nuclear stress test, or echo stress test, or d) coronary artery disease diagnosed by coronary angiography. 3. Willing and able to comply with protocol requirements, including keeping all required visits 4. Willing to participate in the study and able to sign an IRB approved informed consent form 5. Be at least 18 years of age when enrolled in the study
Exclusion criteria
* Patients will be excluded if they meet any of the following: 1. Are pacemaker dependent (defined as a need for ventricular pacing ≥ 20% of the time) 2. Have NYHA Class IV Heart Failure 3. Have persistent or permanent atrial fibrillation 4. Have a known history of intermittent Bundle Branch Block 5. Pregnant or planning a pregnancy during the study participation 6. Have a life expectancy of \< 1 year due to any condition 7. Are currently participating in a clinical investigation that includes an active treatment arm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients Who Experience a False Positive ST Detection in 12 Months FU | 12 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ST Monitoring Feature Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices: Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome. | 2,258 |
| Total | 2,258 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Sponsor terminated investigation | 2,258 |
Baseline characteristics
| Characteristic | ST Monitoring Feature |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1229 Participants |
| Age, Categorical Between 18 and 65 years | 1029 Participants |
| Age, Continuous | 65.4 years STANDARD_DEVIATION 10.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 11 Participants |
| Race (NIH/OMB) Asian | 41 Participants |
| Race (NIH/OMB) Black or African American | 266 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 7 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 34 Participants |
| Race (NIH/OMB) White | 1899 Participants |
| Region of Enrollment United States | 2258 participants |
| Sex: Female, Male Female | 424 Participants |
| Sex: Female, Male Male | 1834 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 270 / 2,258 |
| other Total, other adverse events | 177 / 2,258 |
| serious Total, serious adverse events | 217 / 2,258 |
Outcome results
Primary
Number of Patients Who Experience a False Positive ST Detection in 12 Months FU
Time frame: 12 months
Population: The analysis population includes the number of patients with Clinical Event Committee adjudicated data related to ACS events.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ST Monitoring Feature | Number of Patients Who Experience a False Positive ST Detection in 12 Months FU | 115 Participants |