Automated Myocardial Performance Index Using Samsung HERA W10

NCT04140669 | Terminated FDA Device

• 1 other identifier: 18-005189
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers are using Myocardial performance index (MPI) to assess fetal cardiac function before, during, and after fetal surgery in order to gain more knowledge about fetal cardiac function in high risk pregnancies and the relationship to outcomes of fetal surgical interventions.

Conditions

Twin to Twin Transfusion Syndrome; Congenital Diaphragmatic Hernia; Neural Tube Defects; Lower Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• Automated MPI can used to diagnosis and predict fetal cardiac dysfunction in fetal surgeries.

  48 hours post-operatively

Study Arms (1)

Fetal Surgery Procedures

All pregnant women with a fetus diagnosed with a fetal abnormality and planning to undergo a fetal surgical procedure will be included in this single arm of the study.

Device: Automated Myocardial Performance Index (MPI)

Interventions

Automated Myocardial Performance Index (MPI) DEVICE

Automated Myocardial Performance Index will be performed using Samsung HERA W10 prior too fetal surgical interventions, during surgery, and following surgery.

Fetal Surgery Procedures

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participant eligibility is based on current pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women carrying a fetus with a diagnosis of TTTS, fetal NTD, fetal CDH, or fetal LUTO, and planning to undergo a fetal surgical procedure.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Fetofetal Transfusion; Hernias, Diaphragmatic, Congenital; Neural Tube Defects

Condition Hierarchy (Ancestors)

Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Congenital Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Nervous System Malformations; Nervous System Diseases

Study Officials

• Rodrigo Ruano, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 28, 2019
• Study Start: September 16, 2019
• Primary Completion: July 7, 2020
• Study Completion: July 7, 2020
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)