A Study to Assess Respiratory Muscle Training as a Quality Improvement of Perioperative Care in LVAD 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
- Rochester, Minnesota: 19-004738
Sponsor Protocol Number: 19-004738
About this study
The objectives of this study are to determine the best method for integration of respiratory muscle training (RMT) into the clinical ventricular assist device (VAD) practice at Mayo, to determine the clinical benefits of using RMT in the VAD population at Mayo Clinic, to gain initial insight on means by which RMT can impact clinical outcomes in the VAD population, and to create an algorithm for integration of perioperative RMT in the VAD and other distinct populations at Mayo Clinic.
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:
- Subjects with a history of heart failure scheduled for LVAD placement within 3 weeks (21 days), but at least 5 days of RMT prior to surgery.
Exclusion Criteria:
- Inability to perform the respiratory muscle training (RMT) or more emergent LVAD placement not allowing time for pre- surgical training (less than 5 days).
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 Alfredo Clavell, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available