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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01424722
First received: August 22, 2011
Last updated: September 4, 2013
Last verified: September 2013
  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

Resource links provided by NLM:


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

Contacts
Contact: Jemymah Morley, BS 972-309-8503
Contact: Taraneh Farazi, PhD 408-522-6239

  Hide Study Locations
Locations
United States, Alabama
University Hospital - Univ. of Alabama at Birmingham (UAB) Recruiting
Birmingham, Alabama, United States, 35233
Contact: Rosemary Bubien, RN, MSN    205-934-3056      
Principal Investigator: Hugh Thomas McElderry, MD         
Cardiovascular Associates PC Recruiting
Birmingham, Alabama, United States, 35213
Contact: Tammy Stover, RN    205-599-2259      
Principal Investigator: Sanjeev Hasabnis, DO         
Heart Center Research, LLC Recruiting
Huntsville, Alabama, United States, 35801
Contact: Jessica Marsh    256-519-8276      
Principal Investigator: Scott Allison, MD         
United States, Alaska
Arkansas Heart Hospital Recruiting
Little Rock, Alaska, United States, 72211
Contact: Janae Tableriou    501-614-3641      
Principal Investigator: Scott Beau, MD         
United States, Arizona
Banner Heart Hospital Recruiting
Meza, Arizona, United States, 85206
Contact: Heidi Terry, RN    480-854-5077      
Principal Investigator: Mark Starling, MD         
Arizona Arrhythmia Research Center Recruiting
Phoenix, Arizona, United States, 85006
Contact: Wendy Schwoegler    480-659-7583      
Principal Investigator: Vijendra Swarup, MD         
United States, Arkansas
Arkansas Cardiology Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Angela Goss    501-227-7596      
Principal Investigator: Stephen Greer, MD         
United States, California
Central Cardiology Recruiting
Bakersfield, California, United States, 93308
Contact: Adrian Antonescu    661-323-8384      
Principal Investigator: Peter Nalos, MD         
John Muir Medical Center Recruiting
Concord, California, United States, 94520
Contact: Cindy Warburton    925-674-2584      
Principal Investigator: Sue Eisenberg, MD         
St. Jude Hospital Recruiting
Fullerton, California, United States, 92835
Contact: Karen Hill    714-504-4325      
Principal Investigator: Rahul Doshi, MD         
Glendale Memorial Hospital and Medical Center Recruiting
Glendale, California, United States, 91204
Contact: Jenny Graham    818-502-4755      
Principal Investigator: John P. McKenzie, III, MD         
Cardia Care Specialists Recruiting
Glendale, California, United States, 91203
Contact: Roxana Hernandez    818-507-6405      
Principal Investigator: Amir Hedayati, MD         
Scripps Memorial Hospital La Jolla Recruiting
La Jolla, California, United States, 92037
Contact: Gail Moore    858-652-5577      
Principal Investigator: Steven Higgins, MD         
Long Beach Memorial Recruiting
Long Beach, California, United States, 90806
Contact: Anna Wiggins    562-933-8759      
Principal Investigator: Serge Tobias, MD         
USC University Hospital Recruiting
Los Angeles, California, United States, 90033
Contact: Rene Rivers    323-422-6024      
Principal Investigator: Ray Matthews, MD         
Kaiser Permanente Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Lorena Barreda    626-564-5931      
Principal Investigator: Nigel Gupta, MD         
Cardiac Rhythm Specialists, Inc. Recruiting
Northridge, California, United States, 91325
Contact: Melissa Ramos    818-718-1600      
Principal Investigator: Leo Polosajian, MD         
Sutter Memorial Hospital Recruiting
Sacramento, California, United States, 95819
Contact: Deborah Holmes-Rees    916-733-7102      
Principal Investigator: David Roberts, MD         
United States, Colorado
Colorado Cardiac Alliance Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Susan Stoddard, BSN    719-634-6671 ext 225      
Principal Investigator: Christopher Cole, MD         
United States, Connecticut
Cardiology Associates of Fairfield County Recruiting
Norwalk, Connecticut, United States, 06851
Contact: Rich Keegan    203-445-7093      
Principal Investigator: Mark Heiman, MD         
United States, Delaware
Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Catherine Wade    302-733-2658      
Principal Investigator: Roger Kerzner, MD         
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Richard Quick    202-877-6152      
Principal Investigator: Ron Waksman, MD         
United States, Florida
Manatee Memorial Hospital Recruiting
Bradenton, Florida, United States, 34208
Contact: Terri Burghart    941-404-4390      
Principal Investigator: Anthony Pizzo, MD         
Holy Cross Hospital Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Sandra Vujanic    954-229-8571      
Principal Investigator: Rishi Anand, MD         
First Coast Cardiovascular Institute Recruiting
Jacksonville, Florida, United States, 32216
Contact: Mary Hudson    904-493-3333      
Principal Investigator: David Weisman, MD         
Watson Clinic Center Recruiting
Lakeland, Florida, United States, 33805
Contact: Michelle Bass, RN    863-904-2482 ext 4      
Principal Investigator: Neal Kavesh, MD         
Munroe Regional Medical Center Recruiting
Ocala, Florida, United States, 34471
Contact: Rhonda Grubbs, LPN    352-351-7337      
Principal Investigator: Ram Vasudevan, MD         
Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Leann Goodwin, RN    407-303-8059      
Principal Investigator: Kerry Schwartz, MD         
United States, Georgia
Northeast Georgia Heart Center, PC Recruiting
Gainesville, Georgia, United States, 30501
Contact: Donna Patrick, RN    678-989-5001      
Principal Investigator: Salem N Sayar, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60565
Contact: Martin Elonia    312-926-2671      
Principal Investigator: Susan S Kim, MD         
United States, Indiana
Northern Indiana Research Alliance Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Teresa Park, RN    260-434-6109      
Principal Investigator: Fausto Devecchi, M.D.         
United States, Iowa
Iowa Heart Center Recruiting
West Des Moines, Iowa, United States, 50266
Contact: Sara Burg, RN, BSN    515-633-3845      
Principal Investigator: Magdi Ghali, MD         
United States, Kansas
Mid-America Cardiology Associates, PC Recruiting
Kansas City, Kansas, United States, 66160
Contact: Donita Atkins    913-588-9714      
Principal Investigator: Dendi Raghuveer, MD         
United States, Kentucky
Kentucky Heart Institute / King's Daughter Recruiting
Ashland, Kentucky, United States, 41101
Contact: Bonnie Patrick, RN, BSN    606-408-6817      
Principal Investigator: John Van Deren, MD         
Central Baptist Hospital Recruiting
Lexington, Kentucky, United States, 40503
Contact: Jennifer Isaacs    859-260-6368      
Principal Investigator: Michael Rukavina, M.D.         
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Bettina Collins, RN, BSN    502-852-1377      
Principal Investigator: Greg Deam, MD         
United States, Louisiana
Heart Clinic of Hammond Recruiting
Hammond, Louisiana, United States, 70403
Contact: Cheryl Firmin    985-269-7106      
Principal Investigator: Ghiath Mikdadi, MD         
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Melanie Lunn    504-842-2372      
Principal Investigator: Daniel P Morin, MD         
United States, Maryland
MedStar Research Institute Recruiting
Baltimore, Maryland, United States, 21237
Contact: Alysia Rosner    410-574-1330      
Principal Investigator: Glenn Meininger, MD         
Shady Grove Adventist Hospital Recruiting
Rockville, Maryland, United States, 20850
Contact: Doris Swaim    240-826-6167      
Principal Investigator: Sean Beinart         
United States, Massachusetts
University of Massachusettts Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Kaethe Giaquinto    508-856-2376      
Principal Investigator: Dionyssios Robotis, MD         
United States, Michigan
Thoracic Cardiovascular Healthcare Foundation Recruiting
Lansing, Michigan, United States, 48910
Contact: Sarah Walker    517-483-8414      
Principal Investigator: Ranjan Thakur, MD         
Providence Hospital Recruiting
Southfield, Michigan, United States, 48075
Contact: Cordell Hastings    248-849-2379      
Principal Investigator: Christian Machado, MD         
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Deborah Douglas    231-935-6746      
Principal Investigator: Brian Jaffe, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Celeste Koestler    507-255-2200      
Principal Investigator: Paul Friedman, MD         
United States, Mississippi
Jackson Heart Clinic Recruiting
Jackson, Mississippi, United States, 39216
Contact: Janet Humphreys    601-982-7850 ext 271      
Principal Investigator: Judson Colley, MD         
United States, Missouri
North Kansas City Hospital Recruiting
North Kansas City, Missouri, United States, 64116
Contact: Dianne Kruger-Sargent    816-691-5373      
Principal Investigator: Scott Chapman, MD         
Cardiovascular Specialists of St. John's Recruiting
Springfield, Missouri, United States, 65804
Contact: Kit Creemer, RN    417-820-6184      
Principal Investigator: Shang-Chiun Lee, EP         
Mercy Hospital St. Louis Recruiting
St. Louis, Missouri, United States, 63141
Contact: Erica Frost    314-251-2797      
Principal Investigator: Amit Doshi, M.D.         
United States, New Jersey
Deborah Heart and Lung Center Recruiting
Browns Mills, New Jersey, United States, 08015
Contact: JoEllen Schmidt, RN, MSN    609-893-6611 ext 5024      
Principal Investigator: Raffaele Corbisiero, MD         
Associated Cardiovascular Consultants Recruiting
Cherry Hill, New Jersey, United States, 08034
Contact: Helen Flanagan    856-673-1353 ext 353      
Principal Investigator: Matthew Sandler, MD, FACC         
Englewood Hospital & Medical Center Recruiting
Englewood, New Jersey, United States, 07631
Contact: Meryna Manandhar    201-894-3907      
Principal Investigator: David Feigenblum, MD         
Cardiovascular Associates of the Delaware Valley Recruiting
Haddon Heights, New Jersey, United States, 08035
Contact: Bill Thron    856-582-2000      
Principal Investigator: George Mark, MD         
United States, New Mexico
New Mexico Heart Institute Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Jill Atkins, RN    505-843-2804      
Principal Investigator: Sean P Mazer, MD         
United States, New York
Buffalo Heart Group Recruiting
Buffalo, New York, United States, 14215
Contact: Theresa Giambra    716-836-2966      
Principal Investigator: Irfan Khan, MD         
Stony Brook Medical Center Recruiting
Stony Brook, New York, United States, 11794
Contact: Joyce Quick, RPAC    631-444-8485      
Principal Investigator: Eric Rashba, MD         
United States, North Carolina
LeBauer Cardiovascular Research Foundation Recruiting
Greensboro, North Carolina, United States, 27401
Contact: Vivian Garman    336-832-3791      
Principal Investigator: James Allred, MD         
Forsyth Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Torey Browning, RN    336-718-6074 ext 209      
Principal Investigator: Michael Drucker, MD         
United States, Ohio
Northeast Ohio Cardiovascular Associates Recruiting
Akron, Ohio, United States, 44304
Contact: Thomas Weigand    330-253-8125      
Principal Investigator: Kevin Silver, MD         
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Stephanie Spencer    216-844-2982      
Principal Investigator: Robert Goldstein, MD         
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Raquel Rozich, RN    216-444-4959      
Principal Investigator: Thomas Callahan, MD         
Ohio State Univeristy Recruiting
Columbus, Ohio, United States, 43210
Contact: Jennifer Bremer, RN, BSN    614-247-7387      
Principal Investigator: John Hummel, MD         
Ohio Health Research Institute Recruiting
Columbus, Ohio, United States, 43214
Contact: Carol Strausbaugh    614-566-1253      
Principal Investigator: Sreedhar Billakanty, MD         
EMH Regional Medical Center Recruiting
Elyria, Ohio, United States, 44035
Contact: Darlene Carr    440-366-2264      
Principal Investigator: Kara Quan, MD, FACC         
United States, Oklahoma
Oklahoma Heart Institute at Utica Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Rebecca Poudrier    918-579-5865      
Principal Investigator: Gregory Cogert, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Liz Cannard    503-494-5893      
Principal Investigator: Karl Stajduhar, MD         
United States, Pennsylvania
Capital Cardiovascular Associates Recruiting
Camp Hill, Pennsylvania, United States, 17011
Contact: Joanna Stuck, RN    717-724-6450      
Principal Investigator: David Man, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kimberly Veltre, RN    412-864-1420      
Principal Investigator: Samir Saba, MD         
Allegheny-Singer Research Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Cheryl Snyder, RN    412-359-3802      
Principal Investigator: Christopher Bonnet, MD         
Donald Guthrie Foundation for Education and Research Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Donna Tyburczy    570-882-6070      
Principal Investigator: Pramod Deshmukh, MD         
United States, South Carolina
Columbia Cardiology Consultants Recruiting
Columbia, South Carolina, United States, 29204
Contact: Linda Sherriff    803-744-4909      
Principal Investigator: Robert Malanuk, MD         
Upstate Cardiology Recruiting
Greenville, South Carolina, United States, 29607
Contact: Caroline Kissam    864-282-2089      
Principal Investigator: Richard Vest, MD         
Spartanburg Regional Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Tamara Cole, RN    864-560-1039      
Principal Investigator: David Rodak, M.D., FACC         
United States, Tennessee
Cardiology Consultants Recruiting
Johnson City, Tennessee, United States, 37601
Contact: Deborah Barnes    423-282-3377 ext 282      
Principal Investigator: Fawwaz Hamati, MD         
Methodist University Hospital Recruiting
Memphis, Tennessee, United States, 38104
Contact: Carol Simpson    901-274-2643      
Principal Investigator: James Porterfield, MD         
St. Thomas Hospital Heart Recruiting
Nashville, Tennessee, United States, 37205
Contact: Jane F Jackson, RN    615-222-3024      
Principal Investigator: Stephen Fahrig, MD         
Vanderbilt Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Leslie Hale    615-936-3517      
Principal Investigator: Daniel Lenihan, MD         
United States, Texas
Cardiology Center of Amarillo, LLP Recruiting
Amarillo, Texas, United States, 73106
Contact: Amy Tucker    806-355-2581      
Principal Investigator: Coty Jewell, MD         
Heartplace North Arlington Recruiting
Arlington, Texas, United States, 76012
Contact: Joyce Wallace, RN    817-820-4960      
Principal Investigator: William Nesbitt, MD         
VA Medical Center Dallas Recruiting
Dallas, Texas, United States, 75216
Contact: Anagha Phadke    214-857-2280      
Principal Investigator: Phi Wiegn, MD         
South Texas Cardiovascular Consultants Recruiting
San Antonio, Texas, United States, 78201
Contact: Jodie Addington, RN    210-635-1690      
Principal Investigator: Charles Machell, MD         
Scott & White Memorial Hospital Recruiting
Temple, Texas, United States, 76508
Contact: Stephanie Blue, R.N.    254-724-5373      
Principal Investigator: David Fitzgerald, MD         
Cardiovascular Associates of East Texas Recruiting
Tyler, Texas, United States, 75701
Contact: James Crump, LVN    903-595-2283      
Principal Investigator: Alex Petrakian, MD         
United States, Utah
McKay-Dee Heart Services Recruiting
Ogden, Utah, United States, 84403
Contact: Kim Maguire    801-387-7482      
Principal Investigator: Michael Eifling, MD         
United States, Virginia
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Tina Calayo, RN    757-388-1568      
Principal Investigator: Allen Ciuffo, MD         
Hunter Holmes McGuire VAMC Recruiting
Richmond, Virginia, United States, 23249
Contact: Donna Sargent, RN    804-675-5341      
Principal Investigator: Karoly Kaszala, MD         
United States, Washington
The Hope Heart Institute Recruiting
Bellevue, Washington, United States, 98004
Contact: Liz McKinney    425-450-6188      
Principal Investigator: Alan Heywood, MD         
The Heart Institute at Virginia Mason Recruiting
Seattle, Washington, United States, 98101
Contact: Suzanne Vogt    206-342-6514      
Principal Investigator: Christopher Fellows, MD         
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 4, 2013
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 August 01, 2014