ST Segment Detection Study

Medtronic Cardiac Rhythm and Heart Failure175 enrolled

Overview

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 (EGM) signals in patients that are indicated for an Implantable Cardioverter Defibrillator (ICD) who have coronary artery disease.

Study Type

OBSERVATIONAL

Enrollment

175

Conditions

Coronary Artery Disease

Interventions

ICDDEVICE

Subjects implanted with an ICD.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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

Locations (25)

Unnamed facility

Anchorage, Alaska, United States

Unnamed facility

Brandon, Florida, United States

Outcomes

Primary Outcomes

Number of Participants With ST Segment Changes During Myocardial Infarction

The primary objective of the study was to observe if there are any detectable ST segment changes on an electrogram (EGM) signal from an implanted cardiac defibrillator (ICD) during myocardial infarctions among study participants.

Time frame: Implant to 2 years

Secondary Outcomes

Occurrence of Spontaneous Coronary Event

During the study, spontaneous coronary ischemic events were categorized as STEMI, Non-ST elevated myocardial infarction (NSTEMI), or Unstable Angina. This objective was to provide estimates of rates per patient year for the study population. Rates are presented as: Average number of events per patient year (95% Confidence Interval)

Time frame: Implant to 2 years

ST Segment Changes Measured by an ICD in Subjects Who Test Positive for Ischemia During an Exercise Stress Test

Patients underwent an exercise stress test at their one month study visit. This objective was to summarize the magnitude of the hearts electrical activity signal measured by the implanted ICD during a positive exercise stress test for ischemia.

Time frame: One-month follow-up visit

Number of Years of Stored Data in a Database of the Hearts Electrical Activity in This Specific Patient Population to be Used for Future Research.

The device in this study included an additional capacity to collect and store information about the hearts electrical activity specific to ischemic heart disease. This additional capacity of the device is not currently available in market release ICDs. There is no measure to this objective, other than reporting the number of follow-up years of data accrued, which can be used by Medtronic for additional research.

Time frame: Implant to 2 years

Participants That Consented to Wear a Holter Monitor for a Period of 24 Hours to Collect Heart Sounds Data.

Data from ClinicalTrials.gov

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