Shockless IMPLant Evaluation in Replacements
Overview
Tab Title Description
Study type
ObservationalDescribes 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.
Study IDs
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients with an ICD or Cardiac Resynchronization Therapy Device (CRT-D) undergoing pocket generator replacement.
- Age ≥ 18 years
Exclusion Criteria:
- If there is an absolute contraindication to DFT testing
- NYHA class IV
- Atrial fibrillation (AF) > 24 hours unless on oral anticoagulation or negative TEE
- Recent anoxic brain injury
- Obvious lead malfunction (i.e. short V-V intervals, inappropriate shock for noise, clear fracture on Chest X-ray, etc.)
- Unwilling to provide written informed consent
- Unavailable for Follow-up
- 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 the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Yong-Mei Cha, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available