BATwire - Percutaneous Implant Kit

Date Added
June 8th, 2021
PRO Number
Pro00107572
Researcher
Jean Ruddy

List of Studies


Keywords
Heart, Surgery
Summary

Potential participants are people who have been on medications to treat heart failure, but you continue to have symptoms and qualify to have the FDA approved BAROSTIM NEO™ System implanted. The purpose of this research study is to describe the safety and effectiveness of the delivery system by an ultrasound guided implant procedure in people with heart failure. This is an experimental implant procedure where the data collected during and after procedure will help confirm the safety and effectiveness of the new implant procedure. This will be the first time humans will be implanted using this experimental procedure.

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

BOLT: A Prospective, Multicenter Study of Patients with Deep Vein Thrombosis to Evaluate the Safety and Efficacy of the Indigo® Aspiration System

Date Added
January 12th, 2022
PRO Number
Pro00115726
Researcher
Mathew Wooster

List of Studies


Keywords
Surgery, Vascular
Summary

The purpose of this study is to observe the safety and effectiveness of the Indigo Aspiration System. This study will help determine how study participants recover when the study device is used to remove the clot from the deep veins.

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

A trial of transplanting Hepatitis C-viremic kidneys into Hepatitis C-Negative kidney recipients (THINKER-NEXT)

Date Added
July 3rd, 2022
PRO Number
Pro00119881
Researcher
John McGillicuddy

List of Studies

Keywords
Infectious Diseases, Kidney, Transplant
Summary

This research study is being done to determine whether it is safe to give a kidney transplant from a donor with hepatitis C to a patient without hepatitis C. This study is looking for participants in need of a kidney transplant who are willing to accept a kidney from a patient with hepatitis C.

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

POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in STANDARD RISK PATIENTS with SIGNIFICANT CAROTID ARTERY DISEASE (The ROADSTER 3 Study)

Date Added
January 12th, 2023
PRO Number
Pro00125673
Researcher
Antwana Wright

List of Studies

Keywords
Vascular
Summary

The study is to evaluate real world usage of the ENROUTE® Transcarotid Stent System when used with the ENROUTE® Transcarotid Neuroprotection System in patients with significant carotid artery disease who are at standard risk for adverse events from carotid endarterectomy (CEA). The devices used in the study are not investigational and have been approved for use by the Food and Drug Administration (FDA).

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

Randomized Controlled Trial Comparing the Tolerability and Efficacy of Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients

Date Added
January 24th, 2023
PRO Number
Pro00125967
Researcher
David Taber

List of Studies


Keywords
Drug Studies, Transplant
Summary

The purpose of this study is to find out if there is a difference in how well the standard MUSC cytomegalovirus (CMV) prevention medicine works, compared to a different medicine, in preventing CMV infections in kidney transplant recipients who are at risk for this type of infection, while also assessing the tolerability of these two regimens. The two medication regimens being compared are valganciclovir (FDA approved to prevent and treat CMV infection) vs maribavir (FDA approved to treat CMV infection) plus acyclovir (FDA approved to prevent HSV infection).

Institution
MUSC
Recruitment Contact
Morgan Overstreet
8437928896
overstrm@musc.edu

Multifaceted Intervention To Improve Graft outcome disparities in African American Kidney Transplants

Date Added
April 18th, 2023
PRO Number
Pro00127666
Researcher
David Taber

List of Studies


Keywords
Transplant
Summary

This is a randomized study to test a smartphone app that a pharmacist will use to help kidney transplant patients track their medications, blood pressures, and blood sugars if they have diabetes. The goal of this study is to improve care and outcomes in kidney transplant patients and, in particular, help African American patients have better outcomes after transplant.

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

A Prospective, Single-arm, Multi-center, Open-label Trial Evaluating the Continuous Application of Prevena™ Therapy for up to 14 days

Date Added
April 20th, 2023
PRO Number
Pro00124286
Researcher
Thomas Curran

List of Studies


Keywords
Surgery
Summary

The purpose of this study is to demonstrate that the continuous use of negative pressure dressings for up to 14 days has similar benefits and risks to the continuous use for up to 7 days. The 3M study product being used in this study includes the PREVENA Plus Incision Management System with PREVENA Dressings (Peel & Place, Customizable and ARTHRO●FORM). The study product is considered investigational because it has not been approved by the FDA for continuous use for up to 14 days. It is currently approved for use for up to 7 days.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
(843) 792-8896
(843) 792-8896

Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after CABG (PACeS)

Date Added
May 1st, 2023
PRO Number
Pro00127835
Researcher
Arman Kilic

List of Studies

Keywords
Heart, Surgery
Summary

There are two classes of drugs for preventing blood clots in patients with atrial fibrillation (AF), an irregular heartbeat, after cardiac surgery: antiplatelet drugs (like aspirin) and anticoagulants (blood thinners). This study aims to determine whether the addition of blood thinners to antiplatelet drugs will improve treatment outcomes in patients who develop AF after coronary artery bypass grafting (CABG) surgery.

In this study, you will be randomized (assigned to a group by chance--like flipping a coin) into one of 2 study groups; the assignment to receive the antiplatelet drug alone or the antiplatelet drug plus a blood thinner.

Before discharge from the hospital, you will undergo an electrocardiogram (ECG), which examines the electrical activity of your heart. At 1 and 2 months after randomization, you will receive a phone call from the study staff. At 3 months after randomization, you will return to the institution where you received your surgery for an in-person visit. At 6 months, you will receive a phone call from the study staff. Your total participation will be about 6 months.

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

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Date Added
July 5th, 2023
PRO Number
Pro00126590
Researcher
Marc Katz

List of Studies


Keywords
Cardiovascular, Surgery
Summary

This is an Investigational Device Exemption (IDE) clinical research trial (referred to also as a trial or a research trial) sponsored by AtriCure, Inc (the Sponsor) to learn whether the use of the AtriClip® LAA Exclusion System to close off your left atrial appendage (LAA) during your heart surgery will reduce the risk of stroke. The AtriClip has not been well studied or approved by the FDA for stroke prevention; therefore, this procedure is considered investigational.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
8437928896
overstrm@musc.edu



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