Heart Sounds Measurement Using The Wearable Cardioverter Defibrillator In Hospitalized Acute Heart Failure Patients
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
- Scottsdale/Phoenix, Arizona: 17-006761
Sponsor Protocol Number: 90D0166
About this study
A study to evaluate the changes in heart sounds measurements recorded by the LifeVest® Wearable Cardioverter Defibrillator (WCD) during the medical treatment of hospitalized acute heart failure (AHF) patients.
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 who are 18 years of age or older on the day of screening.
- Patients who are admitted to the hospital with a diagnosis of AHF.
- Included within this group are no more than 3 patients with a known history of atrial fibrillation.
- Patients who have an ejection fraction (EF) ≤ 35% as evidenced by an echocardiogram from the current index presentation or within the last 30 days.
- Patients who are able to be fit with a WCD within 24 hours (ideally within 6 hours) of hospital admission.
- Patients who are able to be fit in the WCD garment (26 to 56 inches measured circumferentially at the level of the xiphoid process).
- Patients who are willing to wear the WCD up to hospital discharge or for a maximum 7 days, whichever occurs first.
- Patients who are willing to continue wearing the WCD for 5 days post-discharge from the hospital.
Exclusion Criteria:
- Patients with evidence of pacing on their admission ECG.
- Patients with cardiac resynchronization therapy device.
- Patients with an implantable cardioverter defibrillator.
- Patients with left ventricular assistive device.
- Patients with heart transplant.
- Patients with acute myocardial infarction diagnosed in the emergency department or at admission.
- Patients who are currently on dialysis or who may undergo ultrafiltration during the index hospitalization.
- Patients who are pregnant.
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 |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Bruce Johnson, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available