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

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring ICD Indicated patients, documented CAD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cardiovascular Associates PC
  • Cardiovascular Associates PC
  • University Hospital - Univ. of Alabama at Birmingham (UAB)
  • Heart Center Research, LLC
  • Banner Heart Hospital
  • Arizona Arrhythmia Research Center
  • Carondelet Specialist Group - Southwest Heartr
  • Arkansas Cardiology
  • Arkansas Heart Hospital
  • Central Cardiology
  • John Muir Medical Center
  • St. Jude Hospital
  • Cardia Care Specialists
  • Glendale Memorial Hospital and Medical Center
  • Scripps Memorial Hospital La Jolla
  • Long Beach Memorial
  • Kaiser Permanente Los Angeles
  • USC University Hospital
  • Cardiac Rhythm Specialists, Inc.
  • Sutter Memorial Hospital
  • Colorado Cardiac Alliance
  • Cardiology Associates of Fairfield County
  • Christiana Hospital
  • Washington Hospital Center
  • Manatee Memorial Hospital
  • Cardiology Consultants PA
  • Holy Cross Hospital
  • First Coast Cardiovascular Institute
  • Watson Clinic Center
  • University of Miami Hospital
  • Munroe Regional Medical Center
  • Florida Hospital Orlando
  • Athens Regional Medical Center
  • Northeast Georgia Heart Center, PC
  • Redmond Regional Medical Center
  • The Queen's Medical Center
  • Northwestern Memorial Hospital
  • Northern Indiana Research Alliance
  • Iowa Heart Center
  • Mid-America Cardiology Associates, PC
  • Kentucky Heart Institute / King's Daughter
  • Central Baptist Hospital
  • University of Louisville
  • Heart Clinic of Hammond
  • Ochsner Medical Center
  • MedStar Research Institute
  • Shady Grove Adventist Hospital
  • University of Massachusettts Medical Center
  • Thoracic Cardiovascular Healthcare Foundation
  • Providence Hospital
  • Munson Medical Center
  • VA Medical Center Minneapolis
  • Mayo Clinic
  • Jackson Heart Clinic
  • North Kansas City Hospital
  • Mercy Hospital St. Louis
  • Mercy Medical Research Institute
  • Deborah Heart and Lung Center
  • Lourdes Cardiology Services
  • Englewood Hospital & Medical Center
  • Cardiovascular Associates of the Delaware Valley
  • New Mexico Heart Institute
  • Southwest Heart PC
  • Buffalo Heart Group
  • Stony Brook Medical Center
  • LeBauer Cardiovascular Research Foundation
  • Forsyth Medical Center
  • Northeast Ohio Cardiovascular Associates
  • University Hospitals of Cleveland
  • The Cleveland Clinic Foundation
  • Ohio State Univeristy
  • Ohio Health Research Institute
  • EMH Regional Medical Center
  • University of Toledo Medical Center
  • Oklahoma Heart Institute at Utica
  • Capital Cardiovascular Associates
  • Penn State Milton Hershey Medical Center
  • Allegheny-Singer Research Institute
  • University of Pittsburgh Medical Center
  • Donald Guthrie Foundation for Education and Research
  • Columbia Cardiology Consultants
  • Upstate Cardiology
  • Spartanburg Regional Medical Center
  • Cardiology Consultants
  • Methodist University Hospital
  • St. Thomas Hospital Heart
  • Vanderbilt Medical Center
  • Cardiology Center of Amarillo, LLP
  • VA Medical Center Dallas
  • South Texas Cardiovascular Consultants
  • Scott & White Memorial Hospital
  • Cardiovascular Associates of East Texas
  • McKay-Dee Heart Services
  • Sentara Norfolk General Hospital
  • Hunter Holmes McGuire VAMC
  • The Hope Heart Institute
  • The Heart Institute at Virginia Mason

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ST Monitoring Feature

Arm Description

ST segment continous monitoring feature enabled and programmed ON

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 22, 2011
Last Updated
January 8, 2021
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01424722
Brief Title
ST Monitoring to Detect Acute Coronary Syndrome Events in Implantable Cardioverter Defibrillator Patients
Acronym
AnalyzeST
Official Title
ST Monitoring to Detect ACS Events in ICD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Study Start Date
August 2011 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
ICD Indicated patients, documented CAD

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ST Monitoring Feature
Arm Type
Experimental
Arm Description
ST segment continous monitoring feature enabled and programmed ON
Intervention Type
Device
Intervention Name(s)
Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices
Other Intervention Name(s)
ST Monitoring Feature
Intervention Description
Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
Primary Outcome Measure Information:
Title
Number of Patients Who Experience a False Positive ST Detection in 12 Months FU
Time Frame
12 months

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

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