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

Coronary Artery Disease Clinical Trial

— AnalyzeST  

Official title:

ST Monitoring to Detect ACS Events in ICD Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01424722
• Other study ID #: CRD_420
• Status: Terminated
• Phase: N/A
• Start date: August 2011
• Est. completion date: June 2017

Study information

• Verified date: January 2021
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2258
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Who Experience a False Positive ST Detection in 12 Months FU		12 months