Investigation of a Novel, magNetically levitated VAD for the treatment of refractOry left Ventricular heArT failurE (INNOVATE Trial)

Date Added
May 15th, 2025
PRO Number
Pro00143150
Researcher
Arman Kilic

List of Studies

Keywords
Cardiovascular, Heart, Surgery
Summary

The objective of the study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3™ (HM3) LVAS (Abbott) when used for the treatment of advanced, refractory, left ventricular heart failure.

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

ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression ADVENT LTO Study

Date Added
May 14th, 2025
PRO Number
Pro00140422
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Heart
Summary

This study is enrolling participants who completed the FARAPULSE ADVENT study and are now nearing the 3 year post atrial fibrillation ablation timepoint. Atrial fibrillation is an irregular heart rhythm caused by electrical signals misfiring. An ablation is a procedure in which those signals are targeted and destroyed to stop the atrial fibrillation. This study will consist of reviewing and collecting medical records since the ablation procedure as well as optional questionnaires and wearing a heart monitor for 7 days to capture the heart's electrical activity. There are no study related follow up visits. Study related risks include loss of confidentiality and possible skin reaction to the electrodes (sticky patches placed on the chest to detect the heart's electrical activity). Individual benefit is not expected but the information learned may contribute to knowledge in this field.

Institution
MUSC
Recruitment Contact
Chandler Schwede
843-792-5998
schwede@musc.edu

A multi-center, double-blind, randomized, placebo-controlled trial to assess efficacy and safety of omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction

Date Added
April 8th, 2025
PRO Number
Pro00143419
Researcher
Brian Houston

List of Studies


Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to find out if the investigational drug/study medicine (omecamtiv mecarbil) can reduce the risk of the effects of heart failure (HF), hospitalization, transplantation, or death. It is hoped that the study medicine increases the heart's ability to pump blood throughout the body, but we need to learn more about its effect in patients who suffer the most from HF symptoms. "Investigational" means that the study medicine is still being tested in research studies and has not been approved by the U.S. Food and Drug Administration (FDA). The study drug will be taken by mouth twice daily.

Participation in this study will last for approximately 3 years, however, participation could last from a few weeks to a few years depending on your time of enrollment. These visits will include physical exams, blood draws, electrocardiograms (ECG), echocardiogram (Echo), blood draws, questionnaires along with receiving the study drug. Participants will receive the study drug and have a 2 week wash out period to ensure tolerance. From there, participants will be randomized to either the treatment group (and receive the medication) or the control group (and not receive the medication). The treatment assignment is determined by randomization, where a computer selects at random which treatment group you will be in (like drawing straws). Neither the subject, nor the blinded study personnel will know which group subjects are in. Neither the subject nor the study doctor or study staff will decide what group subjects are assigned.

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

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

Posterior Wall Substrate Modification Using Irreversible Electroporation for the Treatment of Paroxysmal Atrial Fibrillation

Date Added
March 13th, 2025
PRO Number
Pro00142437
Researcher
Rachel Kaplan

List of Studies

Keywords
Cardiovascular, Heart
Summary

Atrial fibrillation (AF) is an arrhythmia in which the heartbeat becomes irregular due to abnormal electrical signals in the upper chambers of the heart, called the atria. This leads to ineffective pumping of blood by the atria. Complications related to atrial fibrillation are heart failure, stroke, heart palpitations and fatigue. This study is motivated by the need to address the increasing prevalence of AF, which is the most common sustained arrhythmia worldwide. While treatment options for AF include the use of antiarrhythmic drugs which are a group of medications used to treat irregular heartbeats, and catheter ablation procedures, the latter have been associated with significantly better outcomes. Participation in this study consists of 2 phases, 1- randomization 2- ablation procedure and follow-up period.
The randomization to the different groups is considered the research part of the study. Subjects will have equal chance of being randomized (like tossing a coin) to one of two AF ablation treatment groups. All follow up will be according to stand of care practices. Risks include stroke, pericarditis, acute and delayed perforation, hemolysis, acute kidney injury, and coronary artery spasm.

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

PICANTE: PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm

Date Added
February 25th, 2025
PRO Number
Pro00141297
Researcher
Anbukarasi Maran

List of Studies


Keywords
Heart, Surgery
Summary

This study is enrolling subjects with coronary artery disease (blockages in the arteries that supply blood to the heart) who need to undergo a procedure called a Percutaneous Coronary Intervention (PCI) to open up a blocked heart artery. At times, a heart pump is used during a PCI to help reduce the work the heart during the procedure. This study is evaluating a heart pump called the KARDION CORY P4 pump. The KARDION CORY P4 pump is investigational meaning it has not been approved for commercial use by the Food and Drug Administration (FDA). This study will randomize subjects, meaning assign by chance, to receive either the KARDION CORY P4 pump or the Impella CP, which is commercially available.

Study participation will last about 30 days and include up to 6 visits. The study includes blood work, questionnaires, an electrocardiogram (ECG) - a tracing of the heart's electrical activity and an echocardiogram (Echo) - an ultrasound test of the heart.

Risks include risks related to the study device including bleeding, infection, and injury to the blood vessel where the device is placed. There are also risks related to study procedures. There may be benefit and the information learned may benefit others in the future.

Institution
MUSC
Recruitment Contact
Virginia Theodorof
843-876-9078
theodoro@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

A Phase 3, Open-Label, Multicenter Study of I-124 evuzamitide as an Imaging Agent for the Diagnosis of Cardiac Amyloidosis using Positron Emission Tomography Computed Tomography (PET/CT)

Date Added
January 28th, 2025
PRO Number
Pro00141834
Researcher
Jan Griffin

List of Studies

Keywords
Drug Studies, Heart
Summary

This study is testing a new radiotracer dye called I-124 evuzamitide in patients with suspected cardiac amyloidosis. Cardiac amyloidosis occurs when proteins misfold and deposit as amyloid fibrils in the heart. The build up of these fibrils (proteins) cause the heart to enlarge due to wall thickening so the heart has to work harder. Over time, this can lead to heart failure. I-124 evuzamitide is given during a Positron Emissions Tomography/ Computed Tomography (PET/CT) scan to help diagnose cardiac amyloidosis. It is not a treatment for amyloidosis. I-124 evuzamitide is considered investigational meaning it is not approved for commercial use by the Food and Drug Administration. (FDA). It will be given one time through an intravenous line, meaning in the vein before the PET/CT scan.

This study will last about 60 days and include 4 visits. The final study visit will take place at day 30 but medical records will be reviewed up to day 60. In addition to receiving I-124 evuzamitide, participants will also receive potassium iodide, an approved medication, by mouth to take for 3 days to protect the thyroid gland from the radiotracer I-124 evuzamitide, electrocardiogram (ECG), bloodwork and questionnaires.

Institution
MUSC
Recruitment Contact
Ellie Cutright
843-876-5011
cutrighe@musc.edu



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