ST Monitoring to Detect Acute Coronary Syndrome Events in Implantable Cardioverter Defibrillator Patients (AnalyzeST)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Device: Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2258 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	ST Monitoring to Detect ACS Events in ICD Patients
Actual Study Start Date :	August 2011
Actual Primary Completion Date :	June 2017
Actual Study Completion Date :	June 2017

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Percent of patients who experience a false positive ST detection in 12 months FU [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 97 Study Locations

Sponsors and Collaborators

St. Jude Medical

Investigators

Principal Investigator:	Michael Gibson, MD	Boston Clinical Research Institute

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT01424722 History of Changes
Other Study ID Numbers:	CRD_420
First Posted:	August 29, 2011
Last Update Posted:	August 4, 2017
Last Verified:	August 2017

Keywords provided by St. Jude Medical:

ICD Indicated patients; documented CAD

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases	Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases