Clinical trial NCT01424722: ST Monitoring to Detect Acute Coronary Syndrome Events in Implantable Cardioverter Defibrillator Patients
Official title: ST Monitoring to Detect ACS Events in ICD Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: ICD Indicated patients
documented CAD
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2011-08-29
Enrollment: 2258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 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.

Primary outcomes:
measure: Number of Patients Who Experience a False Positive ST Detection in 12 Months FU
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiovascular Associates PC
state: Alabama
city: Birmingham
country: United States
facility: Cardiovascular Associates PC
state: Alabama
city: Birmingham
country: United States
facility: University Hospital - Univ. of Alabama at Birmingham (UAB)
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Mesa
country: United States
facility: Banner Heart Hospital
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arrhythmia Research Center
state: Arizona
city: Tucson
country: United States
facility: Carondelet Specialist Group - Southwest Heartr
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Cardiology
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Bakersfield
country: United States
facility: Central Cardiology
state: California
city: Concord
country: United States
facility: John Muir Medical Center
state: California
city: Fullerton
country: United States
facility: St. Jude Hospital
state: California
city: Glendale
country: United States
facility: Cardia Care Specialists
state: California
city: Glendale
country: United States
facility: Glendale Memorial Hospital and Medical Center
state: California
city: La Jolla
country: United States
facility: Scripps Memorial Hospital La Jolla
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles
state: California
city: Los Angeles
country: United States
facility: USC University Hospital
state: California
city: Northridge
country: United States
facility: Cardiac Rhythm Specialists, Inc.
state: California
city: Sacramento
country: United States
facility: Sutter Memorial Hospital
state: California
city: Colorado Springs
country: United States
facility: Colorado Cardiac Alliance
state: Colorado
city: Norwalk
country: United States
facility: Cardiology Associates of Fairfield County
state: Connecticut
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Bradenton
country: United States
facility: Manatee Memorial Hospital
state: Florida
city: Daytona Beach
country: United States
facility: Cardiology Consultants PA
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Center
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Ocala
country: United States
facility: Munroe Regional Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Orlando
state: Florida
city: Athens
country: United States
facility: Athens Regional Medical Center
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Heart Center, PC
state: Georgia
city: Rome
country: United States
facility: Redmond Regional Medical Center
state: Georgia
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Fort Wayne
country: United States
facility: Northern Indiana Research Alliance
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Kansas City
country: United States
facility: Mid-America Cardiology Associates, PC
state: Kansas
city: Ashland
country: United States
facility: Kentucky Heart Institute / King's Daughter
state: Kentucky
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Hammond
country: United States
facility: Heart Clinic of Hammond
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: MedStar Research Institute
state: Maryland
city: Rockville
country: United States
facility: Shady Grove Adventist Hospital
state: Maryland
city: Worcester
country: United States
facility: University of Massachusettts Medical Center
state: Massachusetts
city: Lansing
country: United States
facility: Thoracic Cardiovascular Healthcare Foundation
state: Michigan
city: Southfield
country: United States
facility: Providence Hospital
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: VA Medical Center Minneapolis
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: North Kansas City
country: United States
facility: North Kansas City Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital St. Louis
state: Missouri
city: Springfield
country: United States
facility: Mercy Medical Research Institute
state: Missouri
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Cherry Hill
country: United States
facility: Lourdes Cardiology Services
state: New Jersey
city: Englewood
country: United States
facility: Englewood Hospital & Medical Center
state: New Jersey
city: Haddon Heights
country: United States
facility: Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
city: Las Cruces
country: United States
facility: Southwest Heart PC
state: New Mexico
city: Buffalo
country: United States
facility: Buffalo Heart Group
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Medical Center
state: New York
city: Greensboro
country: United States
facility: LeBauer Cardiovascular Research Foundation
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Akron
country: United States
facility: Northeast Ohio Cardiovascular Associates
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State Univeristy
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Elyria
country: United States
facility: EMH Regional Medical Center
state: Ohio
city: Toledo
country: United States
facility: University of Toledo Medical Center
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Heart Institute at Utica
state: Oklahoma
city: Camp Hill
country: United States
facility: Capital Cardiovascular Associates
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny-Singer Research Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Sayre
country: United States
facility: Donald Guthrie Foundation for Education and Research
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Cardiology Consultants
state: South Carolina
city: Greenville
country: United States
facility: Upstate Cardiology
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Johnson City
country: United States
facility: Cardiology Consultants
state: Tennessee
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Hospital Heart
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Amarillo
country: United States
facility: Cardiology Center of Amarillo, LLP
state: Texas
city: Dallas
country: United States
facility: VA Medical Center Dallas
state: Texas
city: San Antonio
country: United States
facility: South Texas Cardiovascular Consultants
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Tyler
country: United States
facility: Cardiovascular Associates of East Texas
state: Texas
city: Ogden
country: United States
facility: McKay-Dee Heart Services
state: Utah
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes McGuire VAMC
state: Virginia
city: Bellevue
country: United States
facility: The Hope Heart Institute
state: Washington
city: Seattle
country: United States
facility: The Heart Institute at Virginia Mason
state: Washington
Study officials:
affiliation: Boston Clinical Research Institute
name: Michael Gibson, MD
role: PRINCIPAL_INVESTIGATOR
References: