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

January 8, 2021 updated by: Abbott Medical Devices

ST Monitoring to Detect ACS Events in ICD Patients

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2258

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University Hospital - Univ. of Alabama at Birmingham (UAB)
      • Birmingham, Alabama, United States, 35209
        • Cardiovascular Associates PC
      • Birmingham, Alabama, United States, 35213
        • Cardiovascular Associates PC
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research, LLC
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Banner Heart Hospital
      • Phoenix, Arizona, United States, 85006
        • Arizona Arrhythmia Research Center
      • Tucson, Arizona, United States, 85710
        • Carondelet Specialist Group - Southwest Heartr
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Heart Hospital
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Cardiology
    • California
      • Bakersfield, California, United States, 93308
        • Central Cardiology
      • Concord, California, United States, 94520
        • John Muir Medical Center
      • Fullerton, California, United States, 92835
        • St. Jude Hospital
      • Glendale, California, United States, 91204
        • Glendale Memorial Hospital and Medical Center
      • Glendale, California, United States, 91203
        • Cardia Care Specialists
      • La Jolla, California, United States, 92037
        • Scripps Memorial Hospital La Jolla
      • Long Beach, California, United States, 90806
        • Long Beach Memorial
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles
      • Los Angeles, California, United States, 90033
        • USC University Hospital
      • Northridge, California, United States, 91325
        • Cardiac Rhythm Specialists, Inc.
      • Sacramento, California, United States, 95819
        • Sutter Memorial Hospital
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Colorado Cardiac Alliance
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
        • Cardiology Associates of Fairfield County
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Bradenton, Florida, United States, 34208
        • Manatee Memorial Hospital
      • Daytona Beach, Florida, United States, 32114
        • Cardiology Consultants PA
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
      • Jacksonville, Florida, United States, 32216
        • First Coast Cardiovascular Institute
      • Lakeland, Florida, United States, 33805
        • Watson Clinic Center
      • Miami, Florida, United States, 33136
        • University of Miami Hospital
      • Ocala, Florida, United States, 34471
        • Munroe Regional Medical Center
      • Orlando, Florida, United States, 32803
        • Florida Hospital Orlando
    • Georgia
      • Athens, Georgia, United States, 30606
        • Athens Regional Medical Center
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Heart Center, Pc
      • Rome, Georgia, United States, 30165
        • Redmond Regional Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • The Queen's Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60565
        • Northwestern Memorial Hospital
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Northern Indiana Research Alliance
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Heart Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Mid-America Cardiology Associates, PC
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • Kentucky Heart Institute / King's Daughter
      • Lexington, Kentucky, United States, 40503
        • Central Baptist Hospital
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Louisiana
      • Hammond, Louisiana, United States, 70403
        • Heart Clinic of Hammond
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Medstar Research Institute
      • Rockville, Maryland, United States, 20850
        • Shady Grove Adventist Hospital
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusettts Medical Center
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Thoracic Cardiovascular Healthcare Foundation
      • Southfield, Michigan, United States, 48075
        • Providence Hospital
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • VA Medical Center Minneapolis
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Jackson Heart Clinic
    • Missouri
      • North Kansas City, Missouri, United States, 64116
        • North Kansas City Hospital
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital St. Louis
      • Springfield, Missouri, United States, 65804
        • Mercy Medical Research Institute
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart and Lung Center
      • Cherry Hill, New Jersey, United States, 08034
        • Lourdes Cardiology Services
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital & Medical Center
      • Haddon Heights, New Jersey, United States, 08035
        • Cardiovascular Associates of the Delaware Valley
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • New Mexico Heart Institute
      • Las Cruces, New Mexico, United States, 88011
        • Southwest Heart PC
    • New York
      • Buffalo, New York, United States, 14215
        • Buffalo Heart group
      • Stony Brook, New York, United States, 11794
        • Stony Brook Medical Center
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • LeBauer Cardiovascular Research Foundation
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Medical Center
    • Ohio
      • Akron, Ohio, United States, 44304
        • Northeast Ohio Cardiovascular Associates
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
      • Columbus, Ohio, United States, 43214
        • Ohio Health Research Institute
      • Columbus, Ohio, United States, 43210
        • Ohio State Univeristy
      • Elyria, Ohio, United States, 44035
        • EMH Regional Medical Center
      • Toledo, Ohio, United States, 43614
        • University of Toledo Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Oklahoma Heart Institute at Utica
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Capital Cardiovascular Associates
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton Hershey Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny-Singer Research Institute
      • Sayre, Pennsylvania, United States, 18840
        • Donald Guthrie Foundation for Education and Research
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Columbia Cardiology Consultants
      • Greenville, South Carolina, United States, 29607
        • Upstate Cardiology
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional Medical Center
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
        • Cardiology Consultants
      • Memphis, Tennessee, United States, 38104
        • Methodist University Hospital
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Medical Center
      • Nashville, Tennessee, United States, 37205
        • St. Thomas Hospital Heart
    • Texas
      • Amarillo, Texas, United States, 73106
        • Cardiology Center of Amarillo, LLP
      • Dallas, Texas, United States, 75216
        • VA Medical Center Dallas
      • San Antonio, Texas, United States, 78201
        • South Texas Cardiovascular Consultants
      • Temple, Texas, United States, 76508
        • Scott & White Memorial Hospital
      • Tyler, Texas, United States, 75701
        • Cardiovascular Associates of East Texas
    • Utah
      • Ogden, Utah, United States, 84403
        • McKay-Dee Heart Services
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital
      • Richmond, Virginia, United States, 23249
        • Hunter Holmes McGuire VAMC
    • Washington
      • Bellevue, Washington, United States, 98004
        • The Hope Heart Institute
      • Seattle, Washington, United States, 98101
        • The Heart Institute at Virginia Mason

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ST Monitoring Feature
ST segment continous monitoring feature enabled and programmed ON
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 Names:
  • ST Monitoring Feature

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Patients Who Experience a False Positive ST Detection in 12 Months FU
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Michael Gibson, MD, Boston Clinical Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2011

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

August 22, 2011

First Submitted That Met QC Criteria

August 26, 2011

First Posted (Estimate)

August 29, 2011

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD_420

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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