A Study to Evaluate an ECG Belt for CRT Response
Overview
Tab Title Description
Study type
InterventionalDescribes 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: 19-001651
NCT ID: NCT03504020
Sponsor Protocol Number: 19-001651
About this study
The purpose of this study is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling.
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:
- Age 18 years or older.
- Indicated for CRT, with QRS duration ≥ 130 ms, and planned to be implanted with a market-released Medtronic CRT device with AdaptivCRT and a Medtronic quadripolar LV lead.
- Meets at least one of the following criteria: QRS duration < 150 ms, Prior documented Myocardial Infarction, Non-LBBB.
- LVEDD ≥ 55 mm, as determined by site.
Exclusion Criteria:
- Permanent/persistent AF or presenting with AF.
- Pre-existing or previous LV lead or other confounding devices; e.g., Left Ventricular Assist Device, Vagal Nerve Stimulator.
- Currently implanted with IPG or ICD with > 10% RV pacing.
- Permanent complete AV block.
- Enrolled in a concurrent study that may confound the results of this study. Pre-approval from the study manager is required for enrollment of a patient that is in a concurrent study.
- Less than 1 year life expectancy.
- Vulnerable adults.
- Younger than 18 years of age.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available