RADIANCE TRIO Continued Access Protocol (TRIO CAP) A study of the ReCor Medical Paradise System in Clinical Hypertension

Date Added
April 26th, 2022
PRO Number
Pro00118326
Researcher
Thomas Todoran

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure, Men's Health, Women's Health
Summary

The purpose of this study is to see whether a medical device called the Paradise Renal Denervation System (also called The Paradise System) can lower high blood pressure in participants who are known to have hypertension. The device and the treatment delivered by the device, which is known as renal denervation, are investigational in the United States because they haven't been approved by the US Food and Drug Administration (FDA). Renal denervation is a procedure where a catheter is placed inside the blood vessels (renal arteries) that go to the kidneys. Ultrasound energy is created when the catheter is connected to a power source known as a generator. The ultrasound energy will heat up a small area of tissue around the blood vessel to disable nerves that are surrounding the blood vessels. This is a continued access protocol meaning studies have already been done using this device.

This study is for participants who take 3 or more high blood pressure medications but continue to have high blood pressure. This is a five year study consisting of in person visits at screening, baseline, pre procedure testing, procedure and visits at 1,2,3,4,5,6,12,24,36,48 and 60 months. Study related testing includes BP measurements including 24 hour blood pressure readings, electrocardiograms (ECG), blood work, urine studies, and CT scans. Risks associated with this study include procedure risks such as pain, bleeding or bruising at the catheter insertion site. There are other study related risks such as risks of blood draws, radiation risk associated with the CT scan and loss of confidentiality.

Institution
MUSC
Recruitment Contact
Anthony Awkar
843-876-5009
awkar@musc.edu

EArLy FeasibiLity Study Of the EdWards Transcatheter Atrial ShUnt System (ALT FLOW US)

Date Added
April 26th, 2022
PRO Number
Pro00119538
Researcher
Brian Houston

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure
Summary

This is an early feasibility study to evaluate initial safety, device practicality, and performance of the Edwards Transcatheter Atrial Shunt System (study device) in subjects with heart failure. The Edwards Transcatheter Atrial Shunt System is intended for transcatheter treatment of symptomatic left heart failure patients. The Atrial Shunt opens a channel for blood to flow from the higher pressure left atrium to the lower pressure right atrium via the coronary sinus.

Major study activities include 3 right heart catheterizations (RHC) with exercise, a computed tomography (CT) scan with contrast, multiple ultrasounds of the heart, labs, and other assessments. The length of subject participation in the study is 5 years and includes 11 research visits.

The most common risks associated with the research procedure are those related to the right heart catheterization (RHC) and implant procedure. There are no known benefits of the research device. There may be possible benefits from the research procedure including improvement in quality of life or a decrease in the symptoms caused by heart failure.

The information obtained from this study will show how safe and effective this approach is in treating the symptoms of heart failure. Alternative treatment for heart failure depends on the cause, but may include diet and exercise, managing stress, medication (such as medications to treat leg swelling, high blood pressure, or abnormal heart rate), participation in another research study or continuing with current medical therapy.

Institution
MUSC
Recruitment Contact
Renee Baxley
843-792-1105
baxleyr@musc.edu

ASTER: A PETAL Network Multi-Center Phase 2b Randomized Double-Blinded Placebo-Controlled Trial of Two Different Pharmacologic Therapies (Intravenous Vitamin C or Intravenous Acetaminophen)

Date Added
October 26th, 2021
PRO Number
Pro00115458
Researcher
Andrew Goodwin

List of Studies


Keywords
Hypertension/ High Blood Pressure, Kidney, Pulmonary
Summary

The purpose of this study is to evaluate if Vitamin C and/or Acetaminophen help with the treatment of sepsis. Participants will be given either Acetaminophen, Vitamin C, or a placebo through an IV for up to 5 days while in the ICU. The study aims to find a new approach for improving blood pressure and/ or the function of the lungs and kidneys for patients with sepsis. A maximum of 900 patients will be enrolled in the study.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu