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

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 11-004499
    NCT ID: NCT01424722
    Sponsor Protocol Number: 11-004499

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Study closed to enrollment

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Paul Friedman, M.D.

Closed for enrollment

Additional contact information

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Phone: 800-664-4542 (toll-free)

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