Status:
TERMINATED
ST Segment Detection Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of ST Detect study is to evaluate whether naturally occurring spontaneous coronary events and exercise induced cardiac ischemia, give rise to detectable changes on intracardiac electrogram...
Eligibility Criteria
Inclusion
- Subject is indicated for an ICD implantation
- AND subject must meet ONE of the following:
- Prior acute coronary event
- Previously underwent Percutaneous Coronary Intervention (PCI) or stent procedure
- Multivessel disease
- Positive stress test completed with evidence of ischemic heart disease, as determined by physician, and no subsequent successful revascularization
Exclusion
- Subject is currently dependent on ventricular pacing
- Subject has Left Bundle Brunch Block (LBBB) and/or wide QRS
- Subject has chronic Atrial Fibrillation (AF)
- Subject has dementia
- Subject is indicated for a single chamber device
- Subject requires a right sided or abdominal ICD implant
- Subject is pregnant or in fertile age without secure birth control
- Subject has New York Heart Association (NYHA) class IV or refractory heart failure
- Subject is not expected to survive greater than 12 months
- Subject is participating in other confounding research studies
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT00930969
Start Date
April 1 2008
End Date
March 1 2011
Last Update
February 18 2019
Active Locations (25)
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1
Anchorage, Alaska, United States, 99508
2
Brandon, Florida, United States, 33511
3
Orlando, Florida, United States, 32806
4
Davenport, Iowa, United States, 52803