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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01424722
First received: August 22, 2011
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Coronary Artery Disease
Device: Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: ST Monitoring to Detect ACS Events in ICD Patients

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Percent of patients who experience a false positive ST detection in 12 months FU [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5228
Study Start Date: August 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ST Monitoring Feature 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 Name: ST Monitoring Feature

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424722

Contacts
Contact: Jemymah Morley, BS 972-309-8503
Contact: Taraneh Farazi, PhD 408-522-6239

  Show 88 Study Locations
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Michael Gibson, MD Boston Clinical Research Institute
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01424722     History of Changes
Other Study ID Numbers: CRD_420
Study First Received: August 22, 2011
Last Updated: September 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Medical:
ICD Indicated patients
documented CAD

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 10, 2014