A Study of Automated Myocardial Performance Index Before, During and After Fetal Surgeries using Samsung HERA W10
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: 18-005189
NCT ID: NCT04140669
Sponsor Protocol Number: 18-005189
About this study
The purpose of this study is to evaluate the cardiac function in fetuses with specific conditions before, during, and after fetal interventions using an automated myocardial performance index.
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
- Pregnant women, aged 18 years or older, with one of the following prenatal diagnoses:
- Monochorionic diamniotic twin pregnancies complicated with TTTS
- Fetuses with CDH, but no other structural or chromosomal abnormalities
- Fetuses with NTD, but no other structural or chromosomal abnormalities
- Fetuses with LUTO, but no other structural or chromosomal abnormalities
- That provide written Informed Consent and is willing to comply with protocol requirements
Exclusion Criteria:
- Presence of fetal cardiac anomalies, arrhythmias, associated morbid or lethal anomalies, chromosomal abnormalities.
- Pregnancy complications that are known to impact fetal and neonatal outcomes (e.g., diabetes mellitus, hypertension, autoimmune disorders.
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 Rodrigo Ruano, M.D., Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available