PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE)

Date Added
March 6th, 2023
PRO Number
Pro00125689
Researcher
Jihad Obeid

List of Studies


Keywords
Cholesterol, Dementia, Drug Studies, Geriatrics, Healthy Volunteer Studies, Heart, Memory Loss, Stroke Recovery
Summary

The purpose of this research study is to determine if an already FDA approved drug called atorvastatin can help adults, age 75 or older, live well for longer by preventing dementia, disability, or heart disease. Participants will be assigned by chance to receive either atorvastatin (study drug) or a matching placebo (a tablet that looks like atorvastatin but does not contain any medicine). Study engagement may last up to five years and involves in clinic and/or remote visits, survey questions, potential blood draws, in addition to memory and physical tests. After the first 1-2 visits performed in clinic or remote, the study team will follow-up via phone on a yearly basis to see how participants are doing. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Heart and Vascular Institute
Recruitment Contact
Amy Reynolds
(843) 792-8459
reynoamy@musc.edu

The efficacy of the Smart Pass filter to Reduce the Risk for inappropriate subcutaneous implantable cardioverter-defibrillator shocks from myopotential interference

Date Added
January 23rd, 2023
PRO Number
Pro00117025
Researcher
Michael Gold

List of Studies


Keywords
Heart
Summary

This study is enrolling participants who are already implanted with a S-ICD device (Subcutaneous Implantable Cardioverter Defibrillator, which is a device designed to monitor heart rhythms and deliver a shock to the heart to stop life threatening heart rhythms), and are undergoing a routine outpatient clinic follow up appointment to have their S-ICD checked. The aim of the study is to see if a feature in the device can recognize muscle movement and differentiate movement from irregular heart signals. The study involves doing some simple arm exercises while collecting device data, both with this feature turn on and then with it turned off. Participants will be randomized to either have the feature turned on or off initially then it will be programmed the alternative way and the same exercise testing will be repeated. The study will involve just one visit.

Institution
MUSC
Recruitment Contact
Olivia Washington
843-792-5863
washoliv@musc.edu

Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation

Date Added
September 13th, 2022
PRO Number
Pro00122442
Researcher
Nicholas Amoroso

List of Studies


Keywords
Heart, Surgery
Summary

This study is for participants who have tricuspid regurgitation, a condition in which your heart's tricuspid valve does not close tightly which causes blood to flow backwards in the incorrect direction. This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. In this study, a device called the PASCAL Transcatheter Valve Repair System will be used to treat the tricuspid regurgitation. The PASCAL Transcatheter Valve Repair System is an investigational device meaning it has not been approved for commercial use by the US Food and Drug Administration (FDA). In this study participants will be randomized, meaning randomly assigned like drawing straws, in a 2:1 fashion to either receive the PASCAL Transcatheter Valve Repair System (treatment group) or optimal medical therapy (OMT) (control group). OMT means your medications will be adjusted as needed to provide the most benefit possible. Participants randomized to the OMT group may be eligible to receive the device after completing 2 years of follow up. Participants not eligible for randomization may be eligible for the registry portion of the study if approved by the sponsor. The registry arm participants will not be randomized but will undergo the procedure to place the device.

Participation in this study will last about 5 years and involve up to 15 visits for those in the treatment or registry group and 11 visit for those in the control group. Study related procedures include a right heart catheterization (test to measure the pressures in the heart), echocardiograms (ultrasound test of heart), electrocardiogram or ECG (test of the heart's electrical system) blood work, questionnaires, hall walk test, and physical exam.

Institution
MUSC
Recruitment Contact
Natalie Drain
843-876-5037
drain@musc.edu

PREvention of CardIovascular and DiabEtic kidNey disease in Type 2 Diabetes

Date Added
August 17th, 2022
PRO Number
Pro00122367
Researcher
Harsha Karanchi

List of Studies


Keywords
Diabetes, Drug Studies, Heart, Kidney
Summary

This study will involve taking one or two medications already approved by the Food and Drug Administration (FDA) for treatment of type 2 diabetes to learn more about which diabetes medications are the best for lowering the risk of heart and kidney disease in individuals with type 2 diabetes who are at least 40 years old. Participation includes about 8 study visits over a period of 72 months, which can be performed over the phone remotely or during normal standard of care clinic visits. Participants will be compensated for their time and participation in this research study.

Institution
MUSC
Recruitment Contact
Elizabeth Szwast
(843)-792-4675
hinsone@musc.edu

Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥65 Year-olds (PRIMARY)

Date Added
May 17th, 2022
PRO Number
Pro00119787
Researcher
Marc Katz

List of Studies


Keywords
Heart, Surgery
Summary

The purpose of this research is to compare the risks and benefits of two different procedures used to help patients with mitral valve regurgitation (also known as MR). MR is a condition where the valve does not close fully when it is supposed to, and some blood can then leak back into the left atrium instead of circulating to the rest of the body. The treatment options this study will compare are: (1) transcatheter edge-to-edge repair (abbreviated as TEER; which is a catheter procedure for repairing the mitral valve that doesn't require surgery to open up the heart) and (2) mitral valve repair surgery, which is an open-heart surgical procedure. There are no new or "experimental" procedures being tested in this study: both treatment options are well-established treatments and are regularly performed in patients who have MR.

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

WATCHMAN FLX versus NOAC for EMbolic ProtectION in the management of patients with Non-Valvular Atrial Fibrillation (CHAMPION-AF)

Date Added
April 26th, 2022
PRO Number
Pro00116671
Researcher
Loren Morgan

List of Studies

Keywords
Cardiovascular, Heart, Vascular
Summary

This study will compare WATCHMAN FLXTM ("DEVICE") to a category of OAC called non-vitamin K antagonist oral anticoagulation, also known as NOACs ("CONTROL"). NOAC medications include Pradaxa® (dabigatran), Eliquis® (apixaban), Xarelto® (rivaroxaban), or Savaysa® (edoxaban).The study will research the safety and effectiveness of the WATCHMAN FLXTM device compared to treatment with NOAC therapy to determine if it works for patients with your type of atrial fibrillation who require treatment for potential blood clot formation (thrombus) in the LAA.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Jacqueline Sheriod-Scott
803-255-2927
sheriods@musc.edu

A Multi-arm, Multi-Center, Non-Randomized, Prospective, Clinical Study to Evaluate the Safety and Effectiveness of the NEXUSTM Aortic Arch Stent Graft System in Treating Thoracic Aortic Lesions Involving the Aortic Arch: TRIOMPHE

Date Added
February 14th, 2022
PRO Number
Pro00115968
Researcher
Ravi Veeraswamy

List of Studies


Keywords
Heart, Pulmonary Hypertension, Vascular
Summary

The purpose of this research study is to continue to test how well the Endospan NEXUSTM Aortic Arch Stent Graft System performs in the treatment of a diseased aortic arch. The aortic arch is the top part of the main large vessel that carries blood away from the heart. A stent graft is a self-expanding frame that is covered with a material intended to seal the vessel walls.
The NEXUS Aortic Arch Stent Graft System is delivered to the diseased area of your aorta by traveling through your vascular system using fluoroscopic guidance (x-ray pictures), starting with a small incision or needle puncture near your groin (inner thigh). The NEXUS Aortic Arch Stent Graft System is being studied and is not approved by the FDA which means it is investigational in this study. The NEXUS Aortic Arch Stent Graft System has CE Mark which means it is approved for use in Europe. The NEXUS Aortic Arch Stent Graft System is only available through the clinical study in the United States.

Institution
MUSC
Recruitment Contact
Deanna DeHoff
843-792-8522
dehoff@musc.edu

A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Heart Valve System in the Treatment of High Surgical Risk Patients with Symptomatic, Severe Aortic Regurgitation (AR)

Date Added
December 14th, 2021
PRO Number
Pro00116082
Researcher
Nicholas Amoroso

List of Studies


Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System in a patient population with symptomatic severe Aortic regurgitation ( a condition where the heart's aortic valve does not close tightly and allows some blood to leak back into the heart chamber) requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR).

Your involvement in this study will last approximately 5 years from the time of your procedure. The visits include: Screening/Baseline, Procedure, Pre-Discharge, 1 month, 6 months and annualy for 5 years

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

Date Added
August 24th, 2021
PRO Number
Pro00112813
Researcher
Daniel Steinberg

List of Studies


Keywords
Heart, Surgery
Summary

This study is examining the use, safety and performance of an investigational, meaning not approved for commercial use or sale by the US Food and Drug Administration (FDA) device called Transcatheter Mitral Valve Replacement (TMVR). The TMVR is a device used to treat mitral valve disease in patients with heart failure (weakened heart muscle). The device is placed by a non surgical approach using a delivery catheter (hollow tube) placed in your blood vessel at the top of your leg and directed up to your heart. This five year study will include a screening process to determine you meet eligibility criteria. If you qualify you will then be seen for a baseline visit, undergo the procedure to place the device, day after procedure, at hospital discharge, 1,3,6, 12 months, then yearly for up to 5 years. Study related testing includes physical exams, medication review, 6 minute hall walk test, questionnaires, blood work, CT scans, electrocardiogram or ECG (recording of your heart's electrical activity) and echocardiogram (ultrasound test of your heart).

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

Assessment of myocardial Damage and Encephalopathy by Repeated Trauma (ALERT)

Date Added
May 18th, 2021
PRO Number
Pro00109049
Researcher
Federica del Monte

List of Studies


Keywords
Brain, Dementia, Genetics, Heart
Summary

Two groups of former athletes (who competed in contact and not-contact sports) will undergo brain and heart assessments. Additionally, blood and urines samples will be collected in order to investigate potential markers of disease.

Institution
MUSC
Recruitment Contact
Gianlorenzo Daniele
(843) 442-6981
daniele@musc.edu



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