An Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-7500 in Adults with Hypertrophic Cardiomyopathy

Date Added
March 25th, 2025
PRO Number
Pro00142239
Researcher
Jessica Atkins

List of Studies

Keywords
Drug Studies, Heart
Summary

This study is studying the investigational medication EDG-7500 for the treatment of obstructive and non obstructive hypertrophic cardiomyoapthy. Investigational means it is not approved for sale by the Food and Drug Administration (FDA) The study will test to see if the medication can help the heart expand and fill to help its workload. The study has 4 Parts, each of varying durations. The study will last a minimum of 6 weeks to a maximum of 18 months. Study related procedures include physical exam, electrocardiogram (ECG) - a tracing of the heart's electrical activity, echocardiogram (echo) - ultrasound test of the heart, blood and urine collection, possible genetic testing, and exercise testing. Risks related to the study medication include atrial fibrillation (fast irregular heartbeat), constipation, diarrhea, dizziness/lightheadedness and upper respiratory infection. Other study related risks include loss of confidentiality, unknown risks and risks related to procedures.

Institution
MUSC
Recruitment Contact
Cara Breunig
843-792-7519
breunig@musc.edu

Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients with Heart Failure and Reduced Ejection Fraction

Date Added
March 25th, 2025
PRO Number
Pro00142732
Researcher
Brian Houston

List of Studies


Keywords
Cardiovascular, Heart
Summary

This study is enrolling subjects with heart failure and a reduced ejection fraction meaning the heart does not pump enough blood to meet the body's needs. This study is researching an investigational device (study device) called the Alleviant ALV1 System. Investigational means it has not been approved for commercial use by the Food and Drug Administration. (FDA) This study will test the safety and effectiveness of the Alleviant ALV1 System. The Alleviant ALV1 System is intended to create a shunt (an opening) in the heart to allow for proper blood flow through the heart which may improve your symptoms. No device is left in your heart it is just used to create the shunt. This is a randomized study which means subjects are assigned by chance to either have the study device create this shunt or not have the study device create the shunt. Randomization is 50/50 meaning there is a 50% chance to have the study device create a shunt and a 50% chance the study device will not be used. Using the study device to create the shunt is performed during a right heart catheterization (RHC) so all subjects will undergo the RHC but only 50% will have the shunt. Neither the subjects nor the study doctor will know which group subjects are randomized to but other study staff will know in the event this information is needed. All subjects will stay overnight in the hospital after the procedure. Other study related procedures include echocardiograms - ultrasound test of the heart, electrocardiograms (ECG) - a tracing of the heart's electrical activity, blood work, questionnaires, 6 minute hall walk test, and assessments of heart failure status. Risks include risks related to the study device including blood vessel damage from placing the device in the vein to get to the heart, risks from the right heart catheterization such as bleeding or bruising, abnormal heart beats, and risks related to study related procedures. There may be risks that are not known at this time. Participation in this study is expected to last about 60 months and include approximately 15 in person visits and 3 telephone calls.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
843-876-5783
shr37@musc.edu

A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance with Cell-free DNA versus Endomyocardial Biopsy (ACES-EMB)

Date Added
February 25th, 2025
PRO Number
Pro00141118
Researcher
Adrian Van Bakel

List of Studies


Keywords
Cardiovascular, Heart, Transplant
Summary

This study is an open label, Comparative Effectiveness Research study in patients who receive a heart transplant. Subjects will be enrolled into the study while under evaluation for heart transplantation or on the transplant waiting list prior to heart transplantation. All subjects will follow the center's standard of care surveillance schedule from transplant through 4 weeks post-transplantation. The study objective is to compare the effectiveness of rejection surveillance of heart transplant recipients with Prospera dd-cfDNA to rejection surveillance with endomyocardial biopsy (EMB) in the first post-transplant year.
The Prospera™ test is a non-invasive test intended to detect and quantify the fraction of donor-derived cell-free DNA (dd-cfDNA) to supplement management and surveillance of allograft rejection in patients who have undergone organ transplantation. The subjects may undergo blood draws, echocardiogrphys, medical history and physical exams, antibody testing, nuclear imaging, and MRI as apart of the study. The study period will be during the first 12 months post-transplant. Quality of life questionnaires will be completed at week 4, month 6 and month 12 post-transplant.

Institution
MUSC
Recruitment Contact
Madison Johnson
8437924615
johme@musc.edu

BradycArdia paCemaKer with AV interval modulation for Blood prEssure treAtmenT (BACKBEAT Trial)

Date Added
January 28th, 2025
PRO Number
Pro00141987
Researcher
Sergio Pinski

List of Studies

Keywords
Heart, Hypertension/ High Blood Pressure
Summary

This study is enrolling subjects with high blood pressure who just received a pacemaker (an implantable device placed in the upper chest that monitors the heart rate and can send an electrical signal if needed to pace the heart to maintain a normal heart rate) or are about to undergo a pacemaker implant. This is a randomized study meaning subjects will be assigned by chance to have a new program downloaded to the pacemaker to help control blood pressure or to not receive the program. Subjects will have a 50:50 chance to receive the program. The new program is called AVIM therapy and it is investigational meaning it has not been approved by the US Food and Drug Administration. (FDA) Participation in this study will last about 36 months and include about 10 visits. Study related procedures include blood pressure monitoring including wearing a 24 hour blood pressure monitor, blood work, questionnaires, echocardiogram - an ultrasound test of the heart, pacemaker interrogation (meaning your pacemaker is checked to obtain the information stored on it) and randomization. Study related risks include risks related to the software download such as the risk that the software will not help control blood pressure, risks related to study related procedures and the risk of the loss of confidentiality.

Institution
MUSC
Recruitment Contact
Krista Szymanski
843-876-5783
szymankr@musc.edu

PulseSelectTM PFA Global Registry A part of the Medtronic Cardiac Ablation (MCA) Post-Market Study Platform

Date Added
January 14th, 2025
PRO Number
Pro00141768
Researcher
Rachel Kaplan

List of Studies

Keywords
Heart, Surgery
Summary

This study is enrolling subjects who are undergoing an atrial fibrillation ablation. Atrial fibrillation (AF) is a condition where the heart beats rapidly and irregularly. An ablation procedure can destroy the tissue in the heart that transmits the irregular electrical signals that cause the AF. The ablation procedure will use the PulseSelect™ PFA System which is approved by the Food and Drug Administration (FDA) and uses electroporation (electrical pulses) to destroy the heart tissue.

This study will last about 2 years and include up to 6 visits, some of which can be done virtually. Study procedures include data collection, questionnaires, electrocardiogram (ECG) - which is a tracing of the heart's electrical activity, echocardiogram (Echo) - which is an ultrasound test of the heart, and a Holter monitor - which is a wearable device that continuously records heart rhythm.

Institution
MUSC
Recruitment Contact
Cara Breunig
843-792-7519
breunig@musc.edu

A Randomized Comparison of Cleerly Coronary Artery Disease Stage-Based Care Versus Risk Factor-Based Care for Primary Prevention of Cardiovascular Events

Date Added
January 7th, 2025
PRO Number
Pro00140945
Researcher
Marc-Andre Cornier

List of Studies

Keywords
Cardiovascular, Diabetes, Heart
Summary

This clinical research study is enrolling adults with diabetes, prediabetes or metabolic syndrome. The purpose of the study is to learn more about preventing cardiovascular disease. A heart CT scan will be done at screening and then 2 years later. Qualified participants will be randomly assigned to one of two groups. Participants in the usual care group, will continue to receive care from usual health care provider. In the personalized care group, participants will receive additional health care from a remote cardiologist led team which will individualize treatment based on Cleerly CAD staging results of the heart CT scan. Study is expected to last 3 1/2 years on average but could be 2 - 5 years. Participation is free.

Institution
MUSC
Recruitment Contact
Lori Spillers
843-876-0977
spillerl@musc.edu

Cardiac Resynchronization Therapy Using His/Left Bundle Branch Pacing vs Biventricular Pacing with a Left Ventricular Epicardial Lead in Patients with Heart Failure (HF) with Left Ventricular Ejection Fraction (LVEF) ≤ 50% and with either a Wide QRS Complex (> 130 ms) or with/anticipated > 40% Pacing Randomized Clinical Trial (RCT) (Left vs Left RCT)

Date Added
December 17th, 2024
PRO Number
Pro00140157
Researcher
Anne Kroman

List of Studies

Keywords
Cardiovascular, Heart, Men's Health, Women's Health
Summary

The purpose of this study is to determine if patients with heart failure (HF, meaning a weak heart) with left ventricular ejection fraction (LVEF) ≤ 50% and with an abnormal heart beat can benefit from having pacemaker leads placed in a different location in the heart. We know that people with a weak heart and an abnormal heart beat can benefit from having a pacemaker. Participants in this study will be randomly assigned (like flipping a coin) to one of two treatments (A or B), both of which are standard of care heart pacing treatments:
A. Pacing the heart from two locations in the left ventricle (lower left chamber of the heart)
B. Pacing the heart from one of two other places in the heart (the "His" or the left bundle branch)

The purpose of this study is to compare side by side these two treatments and evaluate if one is better than the other.

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

Evaluating INClisiran as a soLUtion to improve LDL-C management and cloSe care gaps in an Inclusive ASCVD and ASCVD risk equivalent populatiON (VICTORION-INCLUSION)

Date Added
November 26th, 2024
PRO Number
Pro00139806
Researcher
Ashley Waring

List of Studies

Keywords
Cholesterol, Drug Studies, Heart, Men's Health, Women's Health
Summary

This study is enrolling participants with heart disease or at high risk of developing heart disease who are already taking a cholesterol lowering medication referred to as a statin. This study is specifically seeking participants who are historically underrepresented in cardiovascular clinical trials including females, and racial/ethnic minorities, as well as those living in rural areas. This study involves the medication inclisiran which is an approved medication to help lower "bad" cholesterol. In this study participants will be randomized meaning assigned by chance to receive inclisiran along with usual care or not receive inclisiran and will continue usual care for the first 360 days. You will have a 50:50 chance, like flipping a coin, to receive inclisiran. Those participants who are randomized to not receive inclisiran initially will then receive it after day 360 and continue in the study for another 360 days so up to day 720. Participation will take up to 7 study visits.

Study related procedures include collecting medical history, demographics, questionnaires and blood work, as well as receive inclisiran as a shot just under the skin every 4 months. Study related risks include injection site reactions, joint pain or stiffness, bronchitis or an allergic reaction. There is also a risk of loss of confidentiality.

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

A first-in-human, non-significant risk study of the ViewFlex X ICE system

Date Added
November 26th, 2024
PRO Number
Pro00140797
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Heart
Summary

This study involves collecting data and physician feedback while using the ViewFlex X System during a routine electrophysiology (EP) procedure. An electrophysiology procedure is done to correct an electrical abnormality in the heart. The ViewFlex X System is considered investigational meaning it has not been approved for commercial use by the Food and Drug Administration (FDA). The ViewFlex System will obtain and integrate heart images with the mapping information obtained during your procedure. There is also an option to have the procedure videotaped. Study participation lasts until hospital discharge post procedure. Study related risks include risks associated with using the ViewFlex X System, loss of confidentiality and unknown risks.

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

Cryoablation for Monomorphic Ventricular Tachycardia

Date Added
November 12th, 2024
PRO Number
Pro00140469
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Heart, Surgery
Summary

This study is enrolling subjects who are referred for a ventricular tachycardia (VT) ablation. VT is an abnormal heart rhythm that comes from the lower chambers of the heart. An ablation is a procedure to treat abnormal heart rhythms by identifying where the abnormal heart rhythm is starting and then scarring the tissue as a way to stop them. In this study the scars are being made by freezing the tissue. This is called cryoablation. This study will use the Adagio VT Cryoablation System (vCLAS™ Catheter and Console) to perform the cryoablation. This system is considered investigational meaning it has not been approved for use outside of this study by the Food and Drug Administration (FDA). Study participation will last about one year and include the following visits: screening/baseline, procedure, pre discharge, 1, 3, 6 and 12 months. There will also be a telephone call at day 7 post ablation procedure. The study will also collect data including medical history and medications, physical exam findings, data from the procedure, echocardiogram (ultrasound test of the heart, electrocardiogram or ECG (test that captures the electrical activity of the heart) and cardiac MRI. The primary study risks are those related to the ablation procedure including pain, abnormal heart rhythms, low or high blood pressure, and blood vessel or heart muscle damage. There is potential benefit as the procedure may eliminate the abnormal heart rhythm and the information gained may help others with this condition in the future.

Institution
MUSC
Recruitment Contact
Chandler Schwede
873-792-5998
schwede@musc.edu



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