ST Monitoring to Detect Acute Coronary Syndrome Events in Implantable Cardioverter Defibrillator Patients (AnalyzeST)
This study is ongoing, but not recruiting participants.
Sponsor:
St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01424722
First received: August 22, 2011
Last updated: November 1, 2015
Last verified: November 2015
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Device: Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | ST Monitoring to Detect ACS Events in ICD Patients |
Further study details as provided by St. Jude Medical:
Primary Outcome Measures:
- Percent of patients who experience a false positive ST detection in 12 months FU [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 5228 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ST Monitoring Feature |
Device: Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices
Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
Other Name: ST Monitoring Feature
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-
Eligible patients will meet all of the following:
- Have an indication for an ICD implantation or pulse generator change
- 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.
- Willing and able to comply with protocol requirements, including keeping all required visits
- Willing to participate in the study and able to sign an IRB approved informed consent form
- 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:
- Are pacemaker dependent (defined as a need for ventricular pacing ≥ 20% of the time)
- Have NYHA Class IV Heart Failure
- Have persistent or permanent atrial fibrillation
- Have a known history of intermittent Bundle Branch Block
- Pregnant or planning a pregnancy during the study participation
- Have a life expectancy of < 1 year due to any condition
- Are currently participating in a clinical investigation that includes an active treatment arm.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424722
Show 97 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424722
Show 97 Study Locations
Sponsors and Collaborators
St. Jude Medical
Investigators
| Principal Investigator: | Michael Gibson, MD | Boston Clinical Research Institute |
More Information
| Responsible Party: | St. Jude Medical |
| ClinicalTrials.gov Identifier: | NCT01424722 History of Changes |
| Other Study ID Numbers: | CRD_420 |
| Study First Received: | August 22, 2011 |
| Last Updated: | November 1, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by St. Jude Medical:
|
ICD Indicated patients documented CAD |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Acute Coronary Syndrome Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on September 23, 2016