A Study to Remodel the Mitral Annulus following Robotic-Assisted Surgical Mitral Valve Repair
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: 18-006010
Sponsor Protocol Number: 18-006010
About this study
The purpose of this study is to investigate post-operative changes in cardiac structure and function for patients with mitral regurgitation to define heart 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:
- Adult male and female patients, 18 to 99 years of age.
- Patients who previously underwent ECG-gated cardiac CT prior to robotic-assisted mitral valve repair for mitral regurgitation within past 10 years and have had surgical valve repair at least 6 months prior to follow-up CT exam.
- Patients who are able and willing to sign the informed consent.
Exclusion Criteria:
- Minors.
- Patients unable to provide written informed consent.
- Pregnancy (women of childbearing age will be required to have a urine pregnancy test prior to the CT examination due to radiation risk).
- Compromised renal function, defined as eGFR ≤30 (3,4).
- History of prior moderate or severe contrast reaction including: unresponsiveness, severe respiratory distress, convulsions, arrhythmia, cardiopulmonary distress, progressive angioedema, laryngeal edema, dyspnea, bronchospasm, symptomatic tachycardia, symptomatic bradycardia, hypotension, hypertensive crisis.
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 Eric Williamson, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available