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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01424722
First received: August 22, 2011
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Coronary Artery Disease
Device: Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: ST Monitoring to Detect ACS Events in ICD Patients

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Percent of patients who experience a false positive ST detection in 12 months FU [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5228
Study Start Date: August 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424722

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

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01424722     History of Changes
Other Study ID Numbers: CRD_420
Study First Received: August 22, 2011
Last Updated: September 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Medical:
ICD Indicated patients
documented CAD

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014