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

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ClinicalTrials.gov Identifier: NCT01424722
Recruitment Status : Terminated
First Posted : August 29, 2011
Results First Posted : January 28, 2021
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Coronary Artery Disease
Intervention Device: Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices
Enrollment 2258
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ST Monitoring Feature
Hide 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
Reason Not Completed
Sponsor terminated investigation             2258
Arm/Group Title ST Monitoring Feature
Hide 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 Number of Baseline Participants 2258
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2258 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1029
  45.6%
>=65 years
1229
  54.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2258 participants
65.4  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2258 participants
Female
424
  18.8%
Male
1834
  81.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2258 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
   0.0%
Unknown or Not Reported
34
   1.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2258 participants
2258
1.Primary Outcome
Title Number of Patients Who Experience a False Positive ST Detection in 12 Months FU
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 1404
Measure Type: Count of Participants
Unit of Measure: Participants
115
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
Hide 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 (%)
Total   270/2258 (11.96%)    
Hide Serious Adverse Events
ST Monitoring Feature
Affected / at Risk (%) # Events
Total   217/2258 (9.61%)    
Blood and lymphatic system disorders   
Thrombus *  1/2258 (0.04%)  1
Upper extremity thromboembolism *  4/2258 (0.18%)  4
Cardiac disorders   
Endocarditis *  8/2258 (0.35%)  8
Ventricular Arrhythmia *  1/2258 (0.04%)  1
Infections and infestations   
Device infection/erosion *  24/2258 (1.06%)  27
Infection *  10/2258 (0.44%)  10
Sepsis *  4/2258 (0.18%)  4
Injury, poisoning and procedural complications   
Aspiration *  1/2258 (0.04%)  1
Bleeding *  3/2258 (0.13%)  3
Cardiac Perforation *  5/2258 (0.22%)  5
Cardiac Tamponade *  2/2258 (0.09%)  2
Cardiac/respiratory arrest *  2/2258 (0.09%)  2
Coronary sinus perforation/dissection *  1/2258 (0.04%)  1
Decompensated Heart Failure *  2/2258 (0.09%)  2
Discomfort at implant site *  6/2258 (0.27%)  7
Hematoma *  8/2258 (0.35%)  8
High Defibrillation Threshold *  1/2258 (0.04%)  1
Hypotension *  4/2258 (0.18%)  4
Lead entanglement *  1/2258 (0.04%)  1
pericardial effusion *  1/2258 (0.04%)  1
Pericarditis *  2/2258 (0.09%)  3
Pneumothorax *  8/2258 (0.35%)  8
Vascular Injury/Repair *  2/2258 (0.09%)  2
Product Issues   
Battery Depletion at Implant *  1/2258 (0.04%)  1
Device Malfunction *  11/2258 (0.49%)  11
Elevated pacing thresholds *  7/2258 (0.31%)  7
Generator changeout/upgrade *  1/2258 (0.04%)  1
Inappropriate therapy due to non-ventricular rhythm *  10/2258 (0.44%)  13
Lead dislodgment or migration *  62/2258 (2.75%)  68
Lead fracture *  13/2258 (0.58%)  13
Lead Impedance out of range *  13/2258 (0.58%)  13
Lead insulation damage *  2/2258 (0.09%)  2
Lead noise *  3/2258 (0.13%)  4
Loss of capture *  5/2258 (0.22%)  5
Oversensing *  2/2258 (0.09%)  2
Undersensing *  2/2258 (0.09%)  2
Inappropriate therapy due to oversensing *  4/2258 (0.18%)  4
Lead abrasion *  1/2258 (0.04%)  1
Premature battery depletion *  2/2258 (0.09%)  2
Renal and urinary disorders   
Genitourinary disease/disorder *  1/2258 (0.04%)  1
Vascular disorders   
Vascular disease/disorder *  1/2258 (0.04%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ST Monitoring Feature
Affected / at Risk (%) # Events
Total   177/2258 (7.84%)    
Blood and lymphatic system disorders   
Thrombus *  3/2258 (0.13%)  3
Cardiac disorders   
Atrial Arrhythmia *  1/2258 (0.04%)  1
Ventricular Arrhythmia *  2/2258 (0.09%)  2
General disorders   
Exercise limitation *  1/2258 (0.04%)  1
Syncope/pre-syncope *  2/2258 (0.09%)  2
Infections and infestations   
Infection *  7/2258 (0.31%)  7
Device infection/erosion *  2/2258 (0.09%)  2
Injury, poisoning and procedural complications   
Bleeding *  7/2258 (0.31%)  7
Fluid accumulation *  1/2258 (0.04%)  1
Allergic reaction *  3/2258 (0.13%)  3
Cardiac perforation *  1/2258 (0.04%)  1
Cognitive changes *  1/2258 (0.04%)  1
Discomfort at incision/implant site *  9/2258 (0.40%)  10
Edema *  1/2258 (0.04%)  1
Hematoma *  24/2258 (1.06%)  24
Pericardial effusion *  2/2258 (0.09%)  2
Pericarditis *  2/2258 (0.09%)  2
Pneumothorax *  4/2258 (0.18%)  4
Suture protrusion *  1/2258 (0.04%)  1
Musculoskeletal and connective tissue disorders   
Chest pain - non cardiac *  1/2258 (0.04%)  1
Musculoskeletal disease/disorder *  1/2258 (0.04%)  1
Nervous system disorders   
Stroke/Cerebrovascular accident *  3/2258 (0.13%)  3
Product Issues   
Inappropriate therapy due to non-ventricular rhythm *  46/2258 (2.04%)  50
Lead Fracture *  3/2258 (0.13%)  3
Lead noise *  1/2258 (0.04%)  1
Pacemaker mediated tachycardia *  10/2258 (0.44%)  11
Device malfunction *  5/2258 (0.22%)  5
Inappropriate therapy due to oversensing *  6/2258 (0.27%)  6
Lead impedance out of range *  9/2258 (0.40%)  10
Lead insulation damage *  2/2258 (0.09%)  2
Loss of capture *  2/2258 (0.09%)  2
Non-SJM hardware related problem *  1/2258 (0.04%)  1
Oversensing *  5/2258 (0.22%)  5
Possible generator migration *  1/2258 (0.04%)  1
Undersensing *  2/2258 (0.09%)  2
Psychiatric disorders   
Phantom shock * [1]  2/2258 (0.09%)  2
Skin and subcutaneous tissue disorders   
Skin disease/disorder *  2/2258 (0.09%)  2
Wound dehiscence *  1/2258 (0.04%)  1
Vascular disorders   
Hypertension/hypertensive crisis *  1/2258 (0.04%)  1
Upper extremity thromboembolism *  2/2258 (0.09%)  2
*
Indicates events were collected by non-systematic assessment
[1]
Subject imagined shock from device
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Program Director
Organization: Abbott Medical Devices
Phone: 972-309-8087
EMail: clay.cohorn@abbott.com
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01424722    
Other Study ID Numbers: CRD_420
First Submitted: August 22, 2011
First Posted: August 29, 2011
Results First Submitted: February 25, 2019
Results First Posted: January 28, 2021
Last Update Posted: January 28, 2021