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

Product Surveillance Registry (PSR) Aortic, Peripheral, and Venous (APV) Protocol Synopsis

Date Added
October 24th, 2023
PRO Number
Pro00126447
Researcher
Mathew Wooster

List of Studies


Keywords
Vascular
Summary

The purpose of this registry is to collect safety data in patients undergoing aortic aneurysm repair, peripheral vascular intervention, hemodialysis access intervention or peripheral embolization with an eligible Medtronic market-released product(s), including but not limited to balloon catheters, peripheral or carotid stents, stet grafts, and coils, in a real-world setting.

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

Comparison of Theta Burst versus 10 Hz Repetitive Transcranial Magnetic Stimulation for Craving in Smokers

Date Added
February 6th, 2024
PRO Number
Pro00121128
Researcher
Xingbao Li

List of Studies


Keywords
Brain, Healthy Volunteer Studies, Smoking
Summary

Smoking is one of the main public health problems. Smoking cessation is difficult because of nicotine dependence. Repetitive transcranial magnetic stimulation (rTMS) over the frontal head has shown to be effective in the reduction of cigarette consumption and craving. In this study, we will evaluate the efficiency of a new form of rTMS called intermittent theta-burst stimulation (iTBS) for smoking cessation.

Institution
MUSC
Recruitment Contact
Morgan Dancy
843 8765-141
maddoxm@musc.edu

Prophylactic Intra-Operative Ventricular Arrhythmia Ablation in High-Risk LVAD Candidates (PIVATAL)

Date Added
June 12th, 2024
PRO Number
Pro00132289
Researcher
Arman Kilic

List of Studies

Keywords
Cardiovascular
Summary

The study will evaluate the effect of prophylactic intra-operative ventricular tachyarrhythmia ablation (VTA) at the time of left ventricular assist device (LVAD) implantation on post-implant total recurrent VTA events, after accounting for the competing risk of death, from discharge to an average follow-up of 18 months (with a minimum of 9 months) after LVAD implantation.

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

Research Evaluating Vagal Excitation and Anatomical Links

Date Added
June 13th, 2024
PRO Number
Pro00136451
Researcher
Mark George

List of Studies


Keywords
Depression, Epilepsy, Mental Health
Summary

This is an NIH sponsored trial across the US where patients who have been or will be implanted with cervical vagus nerve stimulation (VNS) are then tested in a variety of ways to determine the activity of the VNS on different organs in their body. This will involve implantation for those who qualify, and then two trips to the University of Minnesota for more extensive testing. The device, implantation and travel are all at no cost.

Institution
MUSC
Recruitment Contact
Morgan Dancy
843-876-5141
maddoxm@musc.edu

SAINT NEUROMODULATION SYSTEM FOR THE TREATMENT OF DEPRESSION IN AN INPATIENT SETTING

Date Added
July 23rd, 2024
PRO Number
Pro00126985
Researcher
Mark George

List of Studies


Keywords
Depression, Mental Health, Suicide
Summary

This is an inpatient clinical trial of a new form of transcranial magnetic stimulation with 10 treatments/day for 5 days, called SAINT. It is jointly funded by the NIH and a TMS company, MAGNUS. It is being done at 5 enrolling sites in the US, with total sampe of 100. Depressed and suicidal inpatients will have an MRI scan, then 5 days of treatment, and then a followup MRI scan. Outcome measures are depression and suicide ratings, as well as MRI changes. It is randomized and double blind, so some patients will not be getting active TMS. Importantly this is an adjunctive treatment study on top of all routine clinical treatments.

Institution
MUSC
Recruitment Contact
Morgan Dancy
843-876-5141
maddoxm@musc.edu

Safety and Efficacy of Workflows of High-Volume Single Operators in a Left Atrial Appendage Occlusion Device Implant Procedural Day: SAFE HV

Date Added
October 30th, 2024
PRO Number
Pro00137571
Researcher
Loren Morgan

List of Studies

Keywords
Cardiovascular, Heart, Vascular
Summary

The purpose of this research is to gather information about the effectiveness and safety of Left Atrial Appendage Occlusion (LAAO) device procedures in patients using a Watchman device performed on days where doctors perform a large number of procedures.

The study primary outcome is to evaluate complications during the procedure up to 30 days after the procedure.

The final outcome is to determine successful placement within 31 - 90 days after implant.

Institution
MUSC Heart and Vascular Institute
Recruitment Contact
Jacqueline Sheriod-Scott
8032552927
sheriods@musc.edu

Treatment ResistAnt DepressioN Subcallosal CingulatE Network DBS

Date Added
March 14th, 2025
PRO Number
Pro00137237
Researcher
Mark George

List of Studies


Keywords
Depression, Mental Health
Summary

This study is designed as a prospective, multi-centered, double-blind, randomized, delayed-stimulation/ sham-stimulation controlled 12-month study to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using the Infinity™ Deep Brain Stimulation (DBS) system as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) for adults who are experiencing a Major Depressive Episode (MDE) with inadequate response to 4 or more antidepressant treatments.

Institution
MUSC
Recruitment Contact
Morgan Dancy
843-876-5141
maddoxm@musc.edu

Randomized Controlled Trial of MAGIcTouch - Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease

Date Added
April 1st, 2025
PRO Number
Pro00137869
Researcher
Adam Tanious

List of Studies

Keywords
Vascular
Summary

The purpose of this research is to evaluate the efficacy of a new investigational Sirolimus coated balloon device in the treatment of insufficient blood flow of legs (peripheral arterial disease, PAD).

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



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