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

NCT01424722 | Terminated Results DMC FDA Device

• 1 other identifier: CRD_420
• Study Type: interventional
• Target: 2,258
• Locations: 1 country
• Sites: 97

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.

Conditions

Coronary Artery Disease

Keywords

ICD Indicated patients; documented CAD

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Experience a False Positive ST Detection in 12 Months FU

  12 months

Study Arms (1)

ST Monitoring Feature

EXPERIMENTAL

ST segment continous monitoring feature enabled and programmed ON

Device: Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices

Interventions

Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices DEVICE

Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.

Also known as: ST Monitoring Feature

ST Monitoring Feature

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients will meet all of the following:
• Have an indication for an ICD implantation or pulse generator change
• 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.
• Willing and able to comply with protocol requirements, including keeping all required visits
• Willing to participate in the study and able to sign an IRB approved informed consent form
• Be at least 18 years of age when enrolled in the study

You may not qualify if:

• Patients will be excluded if they meet any of the following:
• Are pacemaker dependent (defined as a need for ventricular pacing ≥ 20% of the time)
• Have NYHA Class IV Heart Failure
• Have persistent or permanent atrial fibrillation
• Have a known history of intermittent Bundle Branch Block
• Pregnant or planning a pregnancy during the study participation
• Have a life expectancy of \< 1 year due to any condition
• Are currently participating in a clinical investigation that includes an active treatment arm.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (97)

Cardiovascular Associates PC

Birmingham, Alabama, 35209, United States

Location

Cardiovascular Associates PC

Birmingham, Alabama, 35213, United States

Location

University Hospital - Univ. of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35233, United States

Location

Heart Center Research, LLC

Huntsville, Alabama, 35801, United States

Location

Banner Heart Hospital

Mesa, Arizona, 85206, United States

Location

Arizona Arrhythmia Research Center

Phoenix, Arizona, 85006, United States

Location

Carondelet Specialist Group - Southwest Heartr

Tucson, Arizona, 85710, United States

Location

Arkansas Cardiology

Little Rock, Arkansas, 72205, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Central Cardiology

Bakersfield, California, 93308, United States

Location

John Muir Medical Center

Concord, California, 94520, United States

Location

St. Jude Hospital

Fullerton, California, 92835, United States

Location

Cardia Care Specialists

Glendale, California, 91203, United States

Location

Glendale Memorial Hospital and Medical Center

Glendale, California, 91204, United States

Location

Scripps Memorial Hospital La Jolla

La Jolla, California, 92037, United States

Location

Long Beach Memorial

Long Beach, California, 90806, United States

Location

Kaiser Permanente Los Angeles

Los Angeles, California, 90027, United States

Location

USC University Hospital

Los Angeles, California, 90033, United States

Location

Cardiac Rhythm Specialists, Inc.

Northridge, California, 91325, United States

Location

Sutter Memorial Hospital

Sacramento, California, 95819, United States

Location

Colorado Cardiac Alliance

Colorado Springs, Colorado, 80907, United States

Location

Cardiology Associates of Fairfield County

Norwalk, Connecticut, 06851, United States

Location

Christiana Hospital

Newark, Delaware, 19718, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Manatee Memorial Hospital

Bradenton, Florida, 34208, United States

Location

Cardiology Consultants PA

Daytona Beach, Florida, 32114, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32216, United States

Location

Watson Clinic Center

Lakeland, Florida, 33805, United States

Location

University of Miami Hospital

Miami, Florida, 33136, United States

Location

Munroe Regional Medical Center

Ocala, Florida, 34471, United States

Location

Florida Hospital Orlando

Orlando, Florida, 32803, United States

Location

Athens Regional Medical Center

Athens, Georgia, 30606, United States

Location

Northeast Georgia Heart Center, PC

Gainesville, Georgia, 30501, United States

Location

Redmond Regional Medical Center

Rome, Georgia, 30165, United States

Location

The Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60565, United States

Location

Northern Indiana Research Alliance

Fort Wayne, Indiana, 46804, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

Mid-America Cardiology Associates, PC

Kansas City, Kansas, 66160, United States

Location

Kentucky Heart Institute / King's Daughter

Ashland, Kentucky, 41101, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Heart Clinic of Hammond

Hammond, Louisiana, 70403, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

MedStar Research Institute

Baltimore, Maryland, 21237, United States

Location

Shady Grove Adventist Hospital

Rockville, Maryland, 20850, United States

Location

University of Massachusettts Medical Center

Worcester, Massachusetts, 01655, United States

Location

Thoracic Cardiovascular Healthcare Foundation

Lansing, Michigan, 48910, United States

Location

Providence Hospital

Southfield, Michigan, 48075, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

VA Medical Center Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

North Kansas City Hospital

North Kansas City, Missouri, 64116, United States

Location

Mercy Medical Research Institute

Springfield, Missouri, 65804, United States

Location

Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Lourdes Cardiology Services

Cherry Hill, New Jersey, 08034, United States

Location

Englewood Hospital & Medical Center

Englewood, New Jersey, 07631, United States

Location

Cardiovascular Associates of the Delaware Valley

Haddon Heights, New Jersey, 08035, United States

Location

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

Location

Southwest Heart PC

Las Cruces, New Mexico, 88011, United States

Location

Buffalo Heart Group

Buffalo, New York, 14215, United States

Location

Stony Brook Medical Center

Stony Brook, New York, 11794, United States

Location

LeBauer Cardiovascular Research Foundation

Greensboro, North Carolina, 27401, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Northeast Ohio Cardiovascular Associates

Akron, Ohio, 44304, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State Univeristy

Columbus, Ohio, 43210, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

EMH Regional Medical Center

Elyria, Ohio, 44035, United States

Location

University of Toledo Medical Center

Toledo, Ohio, 43614, United States

Location

Oklahoma Heart Institute at Utica

Tulsa, Oklahoma, 74104, United States

Location

Capital Cardiovascular Associates

Camp Hill, Pennsylvania, 17011, United States

Location

Penn State Milton Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Donald Guthrie Foundation for Education and Research

Sayre, Pennsylvania, 18840, United States

Location

Columbia Cardiology Consultants

Columbia, South Carolina, 29204, United States

Location

Upstate Cardiology

Greenville, South Carolina, 29607, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Cardiology Consultants

Johnson City, Tennessee, 37601, United States

Location

Methodist University Hospital

Memphis, Tennessee, 38104, United States

Location

St. Thomas Hospital Heart

Nashville, Tennessee, 37205, United States

Location

Vanderbilt Medical Center

Nashville, Tennessee, 37232, United States

Location

Cardiology Center of Amarillo, LLP

Amarillo, Texas, 73106, United States

Location

VA Medical Center Dallas

Dallas, Texas, 75216, United States

Location

South Texas Cardiovascular Consultants

San Antonio, Texas, 78201, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

Cardiovascular Associates of East Texas

Tyler, Texas, 75701, United States

Location

McKay-Dee Heart Services

Ogden, Utah, 84403, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Hunter Holmes McGuire VAMC

Richmond, Virginia, 23249, United States

Location

The Hope Heart Institute

Bellevue, Washington, 98004, United States

Location

The Heart Institute at Virginia Mason

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Clinical Program Director
• Organization: Abbott Medical Devices

clay.cohorn@abbott.com

972-309-8087

Study Officials

• Michael Gibson, MD

  Boston Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2011
• First Posted: August 29, 2011
• Study Start: August 1, 2011
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: January 28, 2021
• Results First Posted: January 28, 2021

Record last verified: 2021-01

Locations

US (97)