Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Risk Patients who have Severe, Symptomatic, Aortic Stenosis Requiring Aortic Valve Replacement

Date Added
January 13th, 2026
PRO Number
Pro00148932
Researcher
Daniel Steinberg

List of Studies


Keywords
Heart
Summary

This research study is being done to evaluate a heart valve called the Navitor Transcatheter Aortic Valve, which may help treat people with severe aortic stenosis, a condition where the heart valve becomes too narrow to open properly. You are being asked to participate because your doctor believes you may benefit from a less-invasive valve replacement instead of open-heart surgery. The study will compare the Navitor valve to other FDA-approved transcatheter valves to see how safe and effective it is for people at low or intermediate surgical risk. The Navitor is considered investigational, meaning it is not yet approved in this population, by the Food and Drug Administration (FDA). Participation may last up to 10 years and involve up to 14 visits, some of which may be done remotely. If you join the study, you will have screening tests, the valve procedure, and regular follow-up visits for several years to check your heart health and how well the valve is working. The risks of participating are similar to those of standard transcatheter valve procedures, such as bleeding, stroke, heart rhythm changes, or infection. While you may experience symptom relief and improved heart function, personal benefit is not guaranteed. Your participation may also help improve future treatment options for patients with aortic stenosis.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
8438765783
shr37@musc.edu

Clinical Investigation Plan Title: Performance of Liver Stiffness Measurement (LSM) by FibroScan® for the Diagnosis of Elevated Central Venous Pressure (CVP)

Date Added
January 13th, 2026
PRO Number
Pro00148626
Researcher
Michele Esposito

List of Studies

Keywords
Cardiovascular, Heart, Non-interventional
Summary

This study is being done to see how well a device called FibroScan can detect high pressure in the large vein that carries blood to the heart. FibroScan is a quick, painless test that measures how stiff the liver is, and researchers want to know if those measurements can help identify people with elevated central venous pressure. You are being asked to participate because you have been suspected of having, or diagnosed with, heart failure. Everyone in the study will have the same tests, which include a FibroScan exam, heart ultrasound, EKG, blood work, and a right-heart catheterization. The study lasts about one week and includes a screening visit, a baseline visit, and a phone check-in. By taking part, you may help researchers learn whether this noninvasive device can provide useful information about heart function. Participation is completely voluntary, and choosing not to join will not affect your medical care.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
843-876-5783
shr37@musc.edu

The RESORB Trial (Resorbable Embolization MicroSpheres for OsteoaRthritis Benefit)

Date Added
January 13th, 2026
PRO Number
Pro00148591
Researcher
Antony Gayed

List of Studies

Keywords
Arthritis, Exercise, Pain
Summary

Genicular Artery Embolization (GAE) is a newer treatment aimed at reducing knee pain caused by osteoarthritis by targeting and reducing inflammation. In people with knee osteoarthritis, inflammation in the joint leads to the growth of tiny new blood vessels, called neovessels. These vessels are not normally present in a healthy joint and contribute to ongoing inflammation and pain.

GAE works by selectively injecting tiny particles into specific arteries that supply blood to these abnormal vessels. This process is called embolization, and it temporarily blocks the flow of blood through the neovessels.

Doctors use a special imaging technique called angiography to guide the procedure. This allows them to see the inflamed area and locate the neovessels, which are larger than normal due to the ongoing inflammation—usually about 1–2 millimeters in diameter.

By blocking these abnormal vessels, GAE helps to reduce the number of inflammatory cells and signaling chemicals (called cytokines) that enter the joint through the bloodstream. This decreases the overall inflammation in the area.

Additionally, the growth of pain-sensing nerves, which often occurs alongside these new vessels, may also be reduced. These nerves—called unmyelinated sensory nerves—can worsen pain when they are activated by inflammation. By decreasing both inflammation and nerve growth, GAE may significantly reduce knee pain in people with osteoarthris

The FDA has not currently approved the study device. Patients will undergo 8 visits over a 12 month period. screening, screening 2,treatment, 30 day follow up,90 days,180,270,365 follow up.

Institution
MUSC
Recruitment Contact
Jacob Rowe
8437928025
roweja@musc.edu

Functional ElectroAnatomiC Isochronal Late Activation Mapping for Empiric VT Ablation Trial

Date Added
January 13th, 2026
PRO Number
Pro00148538
Researcher
Bishnu Dhakal

List of Studies

Keywords
Heart
Summary

This study is evaluating the use of a new technique in ablation of ventricular tachycardia. During a heart procedure called an ablation, doctors must map the heart to find the small areas causing the abnormal rhythm. The study compares two different mapping methods: the standard high-density voltage mapping and a newer method called ILAM, which may help doctors find the problem areas more quickly and precisely. If you join the study, you will be randomly placed—like flipping a coin—into one of the two mapping groups during your procedure. Both methods are already FDA-approved and used for treating VT. You will also have several follow-up visits over 12 months so the study team can check your heart rhythm, device activity (if you have one), and overall health. The goal is to learn whether the newer ILAM method works better or just as well as the standard approach for treating VT.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
8438765783
shr37@musc.edu

Expanded Access Program of AMTAGVI that is Out of Specification for Commercial Release

Date Added
January 13th, 2026
PRO Number
Pro00148315
Researcher
Russell Jenkins

List of Studies

Keywords
Cancer, Drug Studies
Summary

This study is an expanded access protocol for AMTAGVI that has not yet been released for commercial use.

Making the AMTAGVI product involves collecting immune cells from your cancer, growing more of them in the laboratory, and giving them back to you to treat your cancer. AMTAGVI is a commercially available treatment approved by the FDA (US Food and Drug Administration) for advanced melanoma. However, sometimes during the manufacturing of AMTAGVI, the final product is Out of Specification (OOS). This means that the test results for your product do not meet the accepted established criteria. The purpose of this study is to allow expanded access use of out of specification (OOS) AMATAGVI.

Expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. While this use involves an investigational product, this is not a research study.

Risks include vitiligo, swelling of the middle layer of the eye (uveitis), shortness of breath, and increased heart rate. There will be approximately 8-10 study visits over a 24-month period. Visit durations will vary. Patients may or may not benefit from receiving OOS AMTAGVI when compared to receiving no treatment at all.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Ehlers Danlos Syndrome Research Biorepository and Database

Date Added
January 9th, 2026
PRO Number
Pro00147160
Researcher
Russell Norris

List of Studies


Keywords
Allergy, Chronic Fatigue, Genetics, Nervous System, Pain, Rare Diseases, Sleep Disorders, Surgery
Summary

This study aims to create a long-term Ehlers-Danlos syndrome (EDS) biorepository and clinical research database to support gene and biomolecular discovery. The repository will serve as a sustainable resource for advancing EDS-related research by collecting both clinical data and biological samples. Participants who consent will be included in the EDS registry, which stores demographic and operative information, contact details, and biological specimens for current and future studies. Enrolled patients may also choose to be recontacted for future research opportunities. The database will link participants across specialties using identifiers such as name, date of birth, and medical record number. Data collected will include information from electronic health records, such as clinical notes, diagnoses, medications, labs, imaging, anthropometric measures, and procedure reports.

Institution
MUSC
Recruitment Contact
Tayler Goectau
8437921544
goectau@musc.edu

POINT FORCE Registry POst-Market ClINical Follow-up STudy oF the SerranatOR PTA Serration Balloon CathEter

Date Added
January 8th, 2026
PRO Number
Pro00148793
Researcher
Adam Tanious

List of Studies

Keywords
Surgery, Vascular
Summary

To evaluate safety and performance of the Serranator® in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae (access sites used for dialysis) in a real-world scenario.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

MB-TBS: Mindfulness-Based Theta-Burst Stimulation: A Pilot Study Integrating Mindfulness Training Into Accelerated Neuromodulation Therapy for Depression

Date Added
January 8th, 2026
PRO Number
Pro00148491
Researcher
Clayton Olash

List of Studies

Keywords
Depression
Summary

This study examines whether adding brief guided mindfulness exercises to accelerated Transcranial Magnetic Stimulation (TMS) treatment can help people with depression feel better and maintain those improvements longer. Participants will already be receiving accelerated intermittent theta-burst stimulation (aiTBS) as part of their clinical care. During the breaks between TMS sessions, they will have the option to listen to short, app-based mindfulness practices using the commercially available and free to participants Waking Up App. We will track whether this combined approach is practical, how easy participants find the meditations, and whether practicing mindfulness during treatment improves mood, well-being, or long-term recovery. The information gathered will help us design a larger study focused on improving the durability of TMS outcomes.

Institution
MUSC
Recruitment Contact
Clayton Olash
5023778275
olash@musc.edu

Perinatal Mental Health and Trauma-Informed Care: Assessing mental health symptoms, treatment seeking, and intervention needs

Date Added
January 7th, 2026
PRO Number
Pro00147901
Researcher
Cristina Lopez

List of Studies


Keywords
Mental Health, Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

This study aims to explore the prevalence of mental health symptoms, including trauma exposure and posttraumatic stress symptoms in a postpartum population. The study also aims to collect information related to medical and mental health treatment seeking before, during, and after pregnancy as well as feedback on adaptations of future mental health interventions delivered during the postpartum period. Participation in this study includes a 35 minute online survey with questionnaires related to the study aims. Depending on survey responses, participants may be invited to complete an interview with study personnel to provide more specific insight on mental health treatments for perinatal individuals.

Institution
MUSC
Recruitment Contact
Cassidy Chesnutt
843-879-8749
brydonch@musc.edu

A Randomized, Double-Blind, Vehicle-Controlled (Period 1) and Open-Label (Period 2)Phase 3 Study to Investigate the Safety and Efficacy of Tapinarof Cream, 1% in Pediatric Participants Ages 3 Months to < 24 Months with Atopic Dermatitis

Date Added
January 6th, 2026
PRO Number
Pro00148113
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This Phase 3 study evaluates the safety and efficacy of tapinarof cream, 1%, for treating atopic dermatitis (AD) in pediatric participants aged 3 to under 24 months. Previous research, including two Phase 3 pivotal studies and a long-term study, assessed the cream in adults and children as young as 2 years. These studies showed minimal to no systemic exposure in children aged 2 to 17 with extensive AD. The findings support investigating the cream's safety and efficacy in younger participants, specifically infants and toddlers.

Institution
MUSC
Recruitment Contact
Andie Hoskins
843-792-6882
hoskinsa@musc.edu



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