Shockless IMPLant Evaluation in Replacements

Overview

  • Study type

    Observational
  • 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.
  • Site IRB
    • Rochester, Minnesota: 16-006721
    Sponsor Protocol Number: 16-006721

About this study

The purpose of this study is to demonstrate the event rate of the primary outcome, defined as failure of DFT at a single shock at 10 Joules below maximal capacity of the device.

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

Inclusion Criteria:

  1. Patients with an ICD or Cardiac Resynchronization Therapy Device (CRT-D) undergoing pocket generator replacement.
  2. Age ≥ 18 years

Exclusion Criteria:

  1. If there is an absolute contraindication to DFT testing
    1. NYHA class IV
    2. Atrial fibrillation (AF) > 24 hours unless on oral anticoagulation or negative TEE
    3. Recent anoxic brain injury
  2. Obvious lead malfunction (i.e. short V-V intervals, inappropriate shock for noise, clear fracture on Chest X-ray, etc.)
  3. Unwilling to provide written informed consent
  4. Unavailable for Follow-up
  5. Pregnancy (or women of child-bearing potential not taking or willing to take an effective method of contraception).

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Yong-Mei Cha, M.D.

Open for enrollment

Contact information:

Kimberly Osmundson

(507)255-8717

Osmundson.Kimberly@mayo.edu