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

ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve through Implantation of ACURATE in Subjects InDicatEd for TAVR

Date Added
November 23rd, 2021
PRO Number
Pro00114189
Researcher
Daniel Steinberg

List of Studies


Keywords
Heart, Surgery
Summary

This study is enrolling participants with severe aortic stenosis, which is narrowing of one of the heart valves. This condition reduces the amount of blood that can get to the body. This study is collecting data on the safety and effectiveness of an investigational (not yet approved for commercial use by the US FDA (Food and Drug Administration)) device called the ACURATE Aortic Valve System. The procedure to place the device, referred to as TAVR - transcatheter replacement of aortic valve is done in place of open heart surgery. In this study the ACURATE Aortic Valve System will be compared to two commercially available Aortic Valve Systems (valve replacement systems). Participants will be randomized (assigned by choice, like a flip of a coin, in a 1:1 fashion so 50% chance of being assigned to either group like the flip of a coin) to one of two groups. One group will receive the ACURATE Aortic Valve System while the other group will receive one of the commercially available systems. This study will last up to 10 years. Pre-procedure testing is done and reviewed by an eligibility committee to confirm you qualify. Study visits will occur prior to your procedure, during the procedure and throughout your hospital stay, and prior to discharge. Additional visits will occur 1 month and 6 months after your discharge, and then you will either seen or telephoned once per year for the next ten years. Study related testing includes CT scans, physical exams, echocardiograms (ultrasound test of the heart), blood work, and questionnaires.

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

MINDS Imaging Ancillary Study

Date Added
September 1st, 2021
PRO Number
Pro00111435
Researcher
John Rhodes

List of Studies


Keywords
Heart
Summary

Adults with Cognitive Heart Disease (ACHD) now outnumber children with CHD. ACHD patients can demonstrate some neurocognitive deficits which may reduce their quality of life. The goal of this research is to determine if the mind's ability to resist damage of the brain can impact the development and neurocognitive outcomes in ACHD patients.

Institution
MUSC
Recruitment Contact
Terry Headley
843-792-4629
headleyt@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

Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)

Date Added
February 9th, 2021
PRO Number
Pro00104312
Researcher
Daniel Steinberg

List of Studies


Keywords
Heart, Surgery
Summary

This study is being done on patients who have heart failure, a condition where the heart muscle weakens and enlarges and cannot pump blood effectively. The purpose of this study is to assess the safety and effectiveness of a new device called the AccuCinch Ventricular Restoration System and compare it to treatment with standard heart failure medications alone. The AccuCinch Ventricular Restoration System consists of anchors, which attach to your heart muscle, sliders to connect the anchors and a thread like cord that goes through the anchors and is cinched to make your enlarged heart smaller so it can pump more efficiently. The device is implanted in one of the lower pumping chambers of the heart (called left ventricle). The study will have two groups, the treatment group in which participants undergo the device implant in addition to taking heart failure medications and the control group in which participants are treated with heart failure medications alone. Participation will last up to 5 years.

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
843-792-0464
panneeer@musc.edu

Advanced Cardiac Therapies Improving Outcomes Network to Improve the Health of Pediatric and Congenital Heart Disease Patients with Heart Failure

Date Added
September 21st, 2020
PRO Number
Pro00096494
Researcher
Heather Henderson

List of Studies


Keywords
Cardiovascular, Heart, Pediatrics
Summary

The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) is a distributed network-based learning health system (LHS) of care centers, clinicians, researchers and industry representatives partnering with patients who have heart failure and their caregivers with the ultimate aim of achieving health, longevity and quality of life equivalent to the general population. See https://www.actionlearningnetwork.org for more information. The initial focus will be to apply structured quality improvement methods, advanced information technology systems, and sharing of best practices to track and continuously improve health-related outcomes for children with heart failure requiring advanced therapies. In the future, we plan to collaborate with other established registries and learning network (i.e. UNOS, PHTS and Cardiac Networks United) to create an integrated network that improves care throughout all phases of a patient's illness including chronic heart failure, acute decompensated heart failure, ventricular assist device support and transplant.

Institution
MUSC
Recruitment Contact
Heather Henderson
8437929570
hendhea@musc.edu

Molecular links between Alzheimer's Disease and Cardiomyopathy

Date Added
June 16th, 2020
PRO Number
Pro00071077
Researcher
Federica del Monte

List of Studies


Keywords
Alzheimers, Dementia, Genetics, Heart
Summary

Patients with Alzheimer Disease and patients with Heart failure (and a control group free from both the previous mentioned conditions) will be evaluated with cardiac and neuropsychological assessments, in order to investigate the relationship between the two conditions. The study consists of two initial visits, and a 4- and 8-year follow-up visit.

Institution
MUSC
Recruitment Contact
Camilla Bacchin
843-442-6981
bacchin@musc.edu

Right Ventricular Reserve Measures with Cardiac MRI

Date Added
October 16th, 2019
PRO Number
Pro00085562
Researcher
Ryan Tedford

List of Studies


Keywords
Cardiovascular, Heart, Sarcoidosis, Scleroderma, Shortness of Breath
Summary

This research study aims to determine a less invasive way to assess heart function by taking measurements of the heart while subjects are performing an exercise cardiac MRI. Subjects will undergo two exercise phases and MRI measurements will be taken after each exercise phase. These measurements will be compared to available clinical data (including demographic, hemodynamic, radiologic, and functional) and future outcome data.

Institution
MUSC
Recruitment Contact
Melissa Lamicq
843-876-5783
lamicq@musc.edu



-- OR --