Coronary Artery DiseaseAnalyzeSTNCT01424722

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

A study testing Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices in people with Coronary Artery Disease, run by Abbott Medical Devices at 97 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,258 participants
Where: 97 sitesUnited States
Study dates: Aug 2011to Jun 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

97 sites in 1 country.

City, postcode or hospital

97 sites in 1 country

United States97 sites

Northeast Ohio Cardiovascular Associates
Akron, Ohio, 44304
New Mexico Heart Institute
Albuquerque, New Mexico, 87102
Cardiology Center of Amarillo, LLP
Amarillo, Texas, 73106
Kentucky Heart Institute / King's Daughter
Ashland, Kentucky, 41101
Athens Regional Medical Center
Athens, Georgia, 30606
Central Cardiology
Bakersfield, California, 93308
MedStar Research Institute
Baltimore, Maryland, 21237
The Hope Heart Institute
Bellevue, Washington, 98004
Cardiovascular Associates PC
Birmingham, Alabama, 35209
Cardiovascular Associates PC
Birmingham, Alabama, 35213
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35233
Manatee Memorial Hospital
Bradenton, Florida, 34208
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Buffalo Heart Group
Buffalo, New York, 14215
Capital Cardiovascular Associates
Camp Hill, Pennsylvania, 17011
Lourdes Cardiology Services
Cherry Hill, New Jersey, 08034
Northwestern Memorial Hospital
Chicago, Illinois, 60565
University Hospitals of Cleveland
Cleveland, Ohio, 44106
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Colorado Cardiac Alliance
Colorado Springs, Colorado, 80907
Columbia Cardiology Consultants
Columbia, South Carolina, 29204
Ohio State Univeristy
Columbus, Ohio, 43210
Ohio Health Research Institute
Columbus, Ohio, 43214
John Muir Medical Center
Concord, California, 94520
VA Medical Center Dallas
Dallas, Texas, 75216
Cardiology Consultants PA
Daytona Beach, Florida, 32114
EMH Regional Medical Center
Elyria, Ohio, 44035
Englewood Hospital & Medical Center
Englewood, New Jersey, 07631
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Northern Indiana Research Alliance
Fort Wayne, Indiana, 46804
St. Jude Hospital
Fullerton, California, 92835
Northeast Georgia Heart Center, PC
Gainesville, Georgia, 30501
Cardia Care Specialists
Glendale, California, 91203
Glendale Memorial Hospital and Medical Center
Glendale, California, 91204
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, 27401
Upstate Cardiology
Greenville, South Carolina, 29607
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, 08035
Heart Clinic of Hammond
Hammond, Louisiana, 70403
Penn State Milton Hershey Medical Center
Hershey, Pennsylvania, 17033
The Queen's Medical Center
Honolulu, Hawaii, 96813
Heart Center Research, LLC
Huntsville, Alabama, 35801
Jackson Heart Clinic
Jackson, Mississippi, 39216
First Coast Cardiovascular Institute
Jacksonville, Florida, 32216
Cardiology Consultants
Johnson City, Tennessee, 37601
Mid-America Cardiology Associates, PC
Kansas City, Kansas, 66160
Scripps Memorial Hospital La Jolla
La Jolla, California, 92037
Watson Clinic Center
Lakeland, Florida, 33805
Thoracic Cardiovascular Healthcare Foundation
Lansing, Michigan, 48910
Southwest Heart PC
Las Cruces, New Mexico, 88011
Central Baptist Hospital
Lexington, Kentucky, 40503
Arkansas Cardiology
Little Rock, Arkansas, 72205
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Long Beach Memorial
Long Beach, California, 90806
Kaiser Permanente Los Angeles
Los Angeles, California, 90027
USC University Hospital
Los Angeles, California, 90033
University of Louisville
Louisville, Kentucky, 40202
Methodist University Hospital
Memphis, Tennessee, 38104
Banner Heart Hospital
Mesa, Arizona, 85206
University of Miami Hospital
Miami, Florida, 33136
VA Medical Center Minneapolis
Minneapolis, Minnesota, 55417
St. Thomas Hospital Heart
Nashville, Tennessee, 37205
Vanderbilt Medical Center
Nashville, Tennessee, 37232
Ochsner Medical Center
New Orleans, Louisiana, 70121
Christiana Hospital
Newark, Delaware, 19718
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
North Kansas City Hospital
North Kansas City, Missouri, 64116
Cardiac Rhythm Specialists, Inc.
Northridge, California, 91325
Cardiology Associates of Fairfield County
Norwalk, Connecticut, 06851
Munroe Regional Medical Center
Ocala, Florida, 34471
McKay-Dee Heart Services
Ogden, Utah, 84403
Florida Hospital Orlando
Orlando, Florida, 32803
Arizona Arrhythmia Research Center
Phoenix, Arizona, 85006
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Hunter Holmes McGuire VAMC
Richmond, Virginia, 23249
Mayo Clinic
Rochester, Minnesota, 55905
Shady Grove Adventist Hospital
Rockville, Maryland, 20850
Redmond Regional Medical Center
Rome, Georgia, 30165
Sutter Memorial Hospital
Sacramento, California, 95819
South Texas Cardiovascular Consultants
San Antonio, Texas, 78201
Donald Guthrie Foundation for Education and Research
Sayre, Pennsylvania, 18840
The Heart Institute at Virginia Mason
Seattle, Washington, 98101
Providence Hospital
Southfield, Michigan, 48075
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
Mercy Medical Research Institute
Springfield, Missouri, 65804
Mercy Hospital St. Louis
St Louis, Missouri, 63141
Stony Brook Medical Center
Stony Brook, New York, 11794
Scott & White Memorial Hospital
Temple, Texas, 76508
University of Toledo Medical Center
Toledo, Ohio, 43614
Munson Medical Center
Traverse City, Michigan, 49684
Carondelet Specialist Group - Southwest Heartr
Tucson, Arizona, 85710
Oklahoma Heart Institute at Utica
Tulsa, Oklahoma, 74104
Cardiovascular Associates of East Texas
Tyler, Texas, 75701
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Iowa Heart Center
West Des Moines, Iowa, 50266
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
University of Massachusettts Medical Center
Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: ST Monitoring to Detect ACS Events in ICD Patients

Read the 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.

Conditions: Coronary Artery Disease
Being tested: Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices
Keywords: ICD Indicated patients, documented CAD
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devicesDevice
Also called ST Monitoring Feature
Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.

Study groups in NCT01424722
Study group	Role	What they receive
ST Monitoring Feature	Experimental	ST segment continous monitoring feature enabled and programmed ON Receives: Device: Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Jun 2017

First posted29 Aug 2011 (estimated)
Study startAug 2011
Primary completionJun 2017
Study completionJun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2,258 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01424722
Sponsor's protocol ID: CRD_420
Acronym: AnalyzeST
Status last verified: Jan 2021
First submitted: 22 Aug 2011
Last updated: 28 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ST Monitoring to Detect ACS Events in ICD Patients
ClinicalTrials.gov ID: NCT01424722
Acronym / sponsor ID: AnalyzeST / CRD_420
Conditions: Coronary Artery Disease
Keywords: ICD Indicated patients, documented CAD
Study type: Interventional
Recruitment status: Terminated
Enrolment: 2,258 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Aug 2011 (actual)
Primary completion: Jun 2017 (actual)
Study completion: Jun 2017 (actual)
First posted: 29 Aug 2011 (estimated)
Results: Posted 28 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ST Monitoring Feature	Experimental	Device: Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devicesST segment continous monitoring feature enabled and programmed ON

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Eligible patients will meet all of the following:

Key exclusion criteria (8 listed)

Patients will be excluded if they meet any of the following:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devicesAlso: ST Monitoring FeatureAlgorithm for detecting ST changes that may be indicative of an acute coronary syndrome.	Device	ST Monitoring Feature

Primary outcome

Number of Patients Who Experience a False Positive ST Detection in 12 Months FU
Time frame: 12 months

Results and safety

Results posted to the registry on 28 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ST Monitoring Feature	2,258	0

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

Time frame: 12 months. Count of participants. Unit: Participants

Measure	ST Monitoring Feature n = 1404
Value	115

Population analysed: The analysis population includes the number of patients with Clinical Event Committee adjudicated data related to ACS events.

Adverse events

Time frame: Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ST Monitoring Feature	217 of 2,258 (9.6%)	177 of 2,258 (7.8%)	270 of 2,258

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Gibson, MD principal investigator

Boston Clinical Research Institute

97 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices in people with Coronary Artery Disease, run by Abbott Medical Devices at 97 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Who Experience a False Positive ST Detection in 12 Months FU (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01424722.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.