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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2258

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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