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

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01424722
• Collaborator: (none)
• Enrollment: 2,258
• Locations: 97
• Arm: 1
• Actual Duration (Months): 70
• Patients Per Site: 23.3
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2258 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: ST Monitoring to Detect ACS Events in ICD Patients
• Actual Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Jun 1, 2017
• Actual Study Completion Date: Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ST Monitoring Feature ST segment continous monitoring feature enabled and programmed ON	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.; Other Names: ST Monitoring Feature

Outcome Measures

Primary Outcome Measures

1. Number of Patients Who Experience a False Positive ST Detection in 12 Months FU [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiovascular Associates PC	Birmingham	Alabama	United States	35209
2	Cardiovascular Associates PC	Birmingham	Alabama	United States	35213
3	University Hospital - Univ. of Alabama at Birmingham (UAB)	Birmingham	Alabama	United States	35233
4	Heart Center Research, LLC	Huntsville	Alabama	United States	35801
5	Banner Heart Hospital	Mesa	Arizona	United States	85206
6	Arizona Arrhythmia Research Center	Phoenix	Arizona	United States	85006
7	Carondelet Specialist Group - Southwest Heartr	Tucson	Arizona	United States	85710
8	Arkansas Cardiology	Little Rock	Arkansas	United States	72205
9	Arkansas Heart Hospital	Little Rock	Arkansas	United States	72211
10	Central Cardiology	Bakersfield	California	United States	93308
11	John Muir Medical Center	Concord	California	United States	94520
12	St. Jude Hospital	Fullerton	California	United States	92835
13	Cardia Care Specialists	Glendale	California	United States	91203
14	Glendale Memorial Hospital and Medical Center	Glendale	California	United States	91204
15	Scripps Memorial Hospital La Jolla	La Jolla	California	United States	92037
16	Long Beach Memorial	Long Beach	California	United States	90806
17	Kaiser Permanente Los Angeles	Los Angeles	California	United States	90027
18	USC University Hospital	Los Angeles	California	United States	90033
19	Cardiac Rhythm Specialists, Inc.	Northridge	California	United States	91325
20	Sutter Memorial Hospital	Sacramento	California	United States	95819
21	Colorado Cardiac Alliance	Colorado Springs	Colorado	United States	80907
22	Cardiology Associates of Fairfield County	Norwalk	Connecticut	United States	06851
23	Christiana Hospital	Newark	Delaware	United States	19718
24	Washington Hospital Center	Washington	District of Columbia	United States	20010
25	Manatee Memorial Hospital	Bradenton	Florida	United States	34208
26	Cardiology Consultants PA	Daytona Beach	Florida	United States	32114
27	Holy Cross Hospital	Fort Lauderdale	Florida	United States	33308
28	First Coast Cardiovascular Institute	Jacksonville	Florida	United States	32216
29	Watson Clinic Center	Lakeland	Florida	United States	33805
30	University of Miami Hospital	Miami	Florida	United States	33136
31	Munroe Regional Medical Center	Ocala	Florida	United States	34471
32	Florida Hospital Orlando	Orlando	Florida	United States	32803
33	Athens Regional Medical Center	Athens	Georgia	United States	30606
34	Northeast Georgia Heart Center, PC	Gainesville	Georgia	United States	30501
35	Redmond Regional Medical Center	Rome	Georgia	United States	30165
36	The Queen's Medical Center	Honolulu	Hawaii	United States	96813
37	Northwestern Memorial Hospital	Chicago	Illinois	United States	60565
38	Northern Indiana Research Alliance	Fort Wayne	Indiana	United States	46804
39	Iowa Heart Center	West Des Moines	Iowa	United States	50266
40	Mid-America Cardiology Associates, PC	Kansas City	Kansas	United States	66160
41	Kentucky Heart Institute / King's Daughter	Ashland	Kentucky	United States	41101
42	Central Baptist Hospital	Lexington	Kentucky	United States	40503
43	University of Louisville	Louisville	Kentucky	United States	40202
44	Heart Clinic of Hammond	Hammond	Louisiana	United States	70403
45	Ochsner Medical Center	New Orleans	Louisiana	United States	70121
46	MedStar Research Institute	Baltimore	Maryland	United States	21237
47	Shady Grove Adventist Hospital	Rockville	Maryland	United States	20850
48	University of Massachusettts Medical Center	Worcester	Massachusetts	United States	01655
49	Thoracic Cardiovascular Healthcare Foundation	Lansing	Michigan	United States	48910
50	Providence Hospital	Southfield	Michigan	United States	48075
51	Munson Medical Center	Traverse City	Michigan	United States	49684
52	VA Medical Center Minneapolis	Minneapolis	Minnesota	United States	55417
53	Mayo Clinic	Rochester	Minnesota	United States	55905
54	Jackson Heart Clinic	Jackson	Mississippi	United States	39216
55	North Kansas City Hospital	North Kansas City	Missouri	United States	64116
56	Mercy Hospital St. Louis	Saint Louis	Missouri	United States	63141
57	Mercy Medical Research Institute	Springfield	Missouri	United States	65804
58	Deborah Heart and Lung Center	Browns Mills	New Jersey	United States	08015
59	Lourdes Cardiology Services	Cherry Hill	New Jersey	United States	08034
60	Englewood Hospital & Medical Center	Englewood	New Jersey	United States	07631
61	Cardiovascular Associates of the Delaware Valley	Haddon Heights	New Jersey	United States	08035
62	New Mexico Heart Institute	Albuquerque	New Mexico	United States	87102
63	Southwest Heart PC	Las Cruces	New Mexico	United States	88011
64	Buffalo Heart Group	Buffalo	New York	United States	14215
65	Stony Brook Medical Center	Stony Brook	New York	United States	11794
66	LeBauer Cardiovascular Research Foundation	Greensboro	North Carolina	United States	27401
67	Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103
68	Northeast Ohio Cardiovascular Associates	Akron	Ohio	United States	44304
69	University Hospitals of Cleveland	Cleveland	Ohio	United States	44106
70	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
71	Ohio State Univeristy	Columbus	Ohio	United States	43210
72	Ohio Health Research Institute	Columbus	Ohio	United States	43214
73	EMH Regional Medical Center	Elyria	Ohio	United States	44035
74	University of Toledo Medical Center	Toledo	Ohio	United States	43614
75	Oklahoma Heart Institute at Utica	Tulsa	Oklahoma	United States	74104
76	Capital Cardiovascular Associates	Camp Hill	Pennsylvania	United States	17011
77	Penn State Milton Hershey Medical Center	Hershey	Pennsylvania	United States	17033
78	Allegheny-Singer Research Institute	Pittsburgh	Pennsylvania	United States	15212
79	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
80	Donald Guthrie Foundation for Education and Research	Sayre	Pennsylvania	United States	18840
81	Columbia Cardiology Consultants	Columbia	South Carolina	United States	29204
82	Upstate Cardiology	Greenville	South Carolina	United States	29607
83	Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
84	Cardiology Consultants	Johnson City	Tennessee	United States	37601
85	Methodist University Hospital	Memphis	Tennessee	United States	38104
86	St. Thomas Hospital Heart	Nashville	Tennessee	United States	37205
87	Vanderbilt Medical Center	Nashville	Tennessee	United States	37232
88	Cardiology Center of Amarillo, LLP	Amarillo	Texas	United States	73106
89	VA Medical Center Dallas	Dallas	Texas	United States	75216
90	South Texas Cardiovascular Consultants	San Antonio	Texas	United States	78201
91	Scott & White Memorial Hospital	Temple	Texas	United States	76508
92	Cardiovascular Associates of East Texas	Tyler	Texas	United States	75701
93	McKay-Dee Heart Services	Ogden	Utah	United States	84403
94	Sentara Norfolk General Hospital	Norfolk	Virginia	United States	23507
95	Hunter Holmes McGuire VAMC	Richmond	Virginia	United States	23249
96	The Hope Heart Institute	Bellevue	Washington	United States	98004
97	The Heart Institute at Virginia Mason	Seattle	Washington	United States	98101

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Michael Gibson, MD, Boston Clinical Research Institute

Study Documents (Full-Text)

• Statistical Analysis Plan - Feb 5, 2013
• Study Protocol - Feb 25, 2013
• Informed Consent Form - Jun 21, 2013

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01424722
• Other Study ID Numbers: CRD_420
• First Posted: Aug 29, 2011
• Last Update Posted: Jan 28, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Abbott Medical Devices: ICD Indicated patients; documented CAD
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

Participant Flow

Arm/Group Title	ST Monitoring Feature
Arm/Group Description	Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices: Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
Period Title: Overall Study
STARTED	2258
COMPLETED	0
NOT COMPLETED	2258

Baseline Characteristics

Arm/Group Title	ST Monitoring Feature
Arm/Group Description	Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices: Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
Overall Participants	2258
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1029 45.6%
>=65 years	1229 54.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.4 (10.1)
Sex: Female, Male (Count of Participants)
Female	424 18.8%
Male	1834 81.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	11 0.5%
Asian	41 1.8%
Native Hawaiian or Other Pacific Islander	7 0.3%
Black or African American	266 11.8%
White	1899 84.1%
More than one race	0 0%
Unknown or Not Reported	34 1.5%
Region of Enrollment (participants) [Number]
United States	2258 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ST Monitoring Feature
Arm/Group Description	Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices: Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
Measure Participants	1404
Count of Participants [Participants]	115 5.1%

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).
Adverse Event Reporting Description	AEs were Observations, Complications or Other Reported Events (OREs) Complications-events that required invasive intervention (reported under Serious AEs here) Observations-events managed without invasive intervention (reported under Non-serious AEs here) ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE *Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
Arm/Group Title	ST Monitoring Feature
Arm/Group Description	Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices: Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
All Cause Mortality
	ST Monitoring Feature
	Affected / at Risk (%)	# Events
Total	270/2258 (12%)
Serious Adverse Events
	ST Monitoring Feature
	Affected / at Risk (%)	# Events
Total	217/2258 (9.6%)
Blood and lymphatic system disorders
Thrombus	1/2258 (0%)	1
Upper extremity thromboembolism	4/2258 (0.2%)	4
Cardiac disorders
Endocarditis	8/2258 (0.4%)	8
Ventricular Arrhythmia	1/2258 (0%)	1
Infections and infestations
Device infection/erosion	24/2258 (1.1%)	27
Infection	10/2258 (0.4%)	10
Sepsis	4/2258 (0.2%)	4
Injury, poisoning and procedural complications
Aspiration	1/2258 (0%)	1
Bleeding	3/2258 (0.1%)	3
Cardiac Perforation	5/2258 (0.2%)	5
Cardiac Tamponade	2/2258 (0.1%)	2
Cardiac/respiratory arrest	2/2258 (0.1%)	2
Coronary sinus perforation/dissection	1/2258 (0%)	1
Decompensated Heart Failure	2/2258 (0.1%)	2
Discomfort at implant site	6/2258 (0.3%)	7
Hematoma	8/2258 (0.4%)	8
High Defibrillation Threshold	1/2258 (0%)	1
Hypotension	4/2258 (0.2%)	4
Lead entanglement	1/2258 (0%)	1
pericardial effusion	1/2258 (0%)	1
Pericarditis	2/2258 (0.1%)	3
Pneumothorax	8/2258 (0.4%)	8
Vascular Injury/Repair	2/2258 (0.1%)	2
Product Issues
Battery Depletion at Implant	1/2258 (0%)	1
Device Malfunction	11/2258 (0.5%)	11
Elevated pacing thresholds	7/2258 (0.3%)	7
Generator changeout/upgrade	1/2258 (0%)	1
Inappropriate therapy due to non-ventricular rhythm	10/2258 (0.4%)	13
Lead dislodgment or migration	62/2258 (2.7%)	68
Lead fracture	13/2258 (0.6%)	13
Lead Impedance out of range	13/2258 (0.6%)	13
Lead insulation damage	2/2258 (0.1%)	2
Lead noise	3/2258 (0.1%)	4
Loss of capture	5/2258 (0.2%)	5
Oversensing	2/2258 (0.1%)	2
Undersensing	2/2258 (0.1%)	2
Inappropriate therapy due to oversensing	4/2258 (0.2%)	4
Lead abrasion	1/2258 (0%)	1
Premature battery depletion	2/2258 (0.1%)	2
Renal and urinary disorders
Genitourinary disease/disorder	1/2258 (0%)	1
Vascular disorders
Vascular disease/disorder	1/2258 (0%)	1
Other (Not Including Serious) Adverse Events
	ST Monitoring Feature
	Affected / at Risk (%)	# Events
Total	177/2258 (7.8%)
Blood and lymphatic system disorders
Thrombus	3/2258 (0.1%)	3
Cardiac disorders
Atrial Arrhythmia	1/2258 (0%)	1
Ventricular Arrhythmia	2/2258 (0.1%)	2
General disorders
Exercise limitation	1/2258 (0%)	1
Syncope/pre-syncope	2/2258 (0.1%)	2
Infections and infestations
Infection	7/2258 (0.3%)	7
Device infection/erosion	2/2258 (0.1%)	2
Injury, poisoning and procedural complications
Bleeding	7/2258 (0.3%)	7
Fluid accumulation	1/2258 (0%)	1
Allergic reaction	3/2258 (0.1%)	3
Cardiac perforation	1/2258 (0%)	1
Cognitive changes	1/2258 (0%)	1
Discomfort at incision/implant site	9/2258 (0.4%)	10
Edema	1/2258 (0%)	1
Hematoma	24/2258 (1.1%)	24
Pericardial effusion	2/2258 (0.1%)	2
Pericarditis	2/2258 (0.1%)	2
Pneumothorax	4/2258 (0.2%)	4
Suture protrusion	1/2258 (0%)	1
Musculoskeletal and connective tissue disorders
Chest pain - non cardiac	1/2258 (0%)	1
Musculoskeletal disease/disorder	1/2258 (0%)	1
Nervous system disorders
Stroke/Cerebrovascular accident	3/2258 (0.1%)	3
Product Issues
Inappropriate therapy due to non-ventricular rhythm	46/2258 (2%)	50
Lead Fracture	3/2258 (0.1%)	3
Lead noise	1/2258 (0%)	1
Pacemaker mediated tachycardia	10/2258 (0.4%)	11
Device malfunction	5/2258 (0.2%)	5
Inappropriate therapy due to oversensing	6/2258 (0.3%)	6
Lead impedance out of range	9/2258 (0.4%)	10
Lead insulation damage	2/2258 (0.1%)	2
Loss of capture	2/2258 (0.1%)	2
Non-SJM hardware related problem	1/2258 (0%)	1
Oversensing	5/2258 (0.2%)	5
Possible generator migration	1/2258 (0%)	1
Undersensing	2/2258 (0.1%)	2
Psychiatric disorders
Phantom shock	2/2258 (0.1%)	2
Skin and subcutaneous tissue disorders
Skin disease/disorder	2/2258 (0.1%)	2
Wound dehiscence	1/2258 (0%)	1
Vascular disorders
Hypertension/hypertensive crisis	1/2258 (0%)	1
Upper extremity thromboembolism	2/2258 (0.1%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.