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

A Phase III, Randomized, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared with Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients with Heart Failure and Impaired Kidney Function

Date Added
October 8th, 2024
PRO Number
Pro00138745
Researcher
Vishal Rao

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart, Kidney
Summary

We are doing this study to learn more about how effective, safe and tolerable an experimental drug called balcinrenone is when used in combination with dapagliflozin for treating patients with heart failure and impaired kidney function and also to better understand the studied disease and associated health problems. Dapagliflozin is an approved drug to treat patients with heart failure, chronic kidney disease and type 2 diabetes mellitus.

Institution
MUSC
Recruitment Contact
Lauren Wakefield
843-876-5049
wakefila@musc.edu

RandomizEd trial to DEtermine the efficacy and safety of FINErenone on morbidity and mortality among heart failure patients with left ventricular ejection fraction greater than or equal to 40% hospitalized due to an episode of acute decompensated Heart Failure (REDEFINE-HF)

Date Added
September 10th, 2024
PRO Number
Pro00137918
Researcher
Daniel Silverman

List of Studies

Keywords
Cardiovascular, Heart
Summary

The purpose of the study is to determine whether FINErenone reduces total (first and future) Heart Failure events and cardiovascular death compared with placebo in patients hospitalized with acute decompensated Heart Failure with Mid-Range Ejection Fraction and Heart Failure with Preserved Ejection Fraction (HFmrEF/HFpEF. The study will also look at information obtained from the tests performed as part of the study to see if subjects have improvement in symptoms of heart failure. Participation in this study will last approximately 36 months. During the study period subjects will be asked to attend regular study visits with the research coordinator. These visits will include such activities such as vitals, blood tests and questionnaires. There will be 8 visits as part of participation in this clinical trial. Participants will be randomized to either the treatment group (and receive the medication) or the control group (and not receive the medication). Subjects will have a 50:50 chance of receiving the study medication during their participation in the trial. The treatment assignment is determined by randomization, where a computer selects at random which treatment group you will be in (like flipping a coin). Neither the subject, nor the blinded personnel will know which group subjects are in. Neither the subject nor the study doctor will decide what group subjects are assigned.

Institution
MUSC
Recruitment Contact
Kara Loutzenhiser
843-792-1238
loutzenh@musc.edu

TRiCares Topaz Transfemoral TRICUspid Heart Valve REplacement System Early Feasibility Study (TRICURE EFS)

Date Added
August 27th, 2024
PRO Number
Pro00138879
Researcher
Nicholas Amoroso

List of Studies


Keywords
Cardiovascular, Heart
Summary

You are invited to volunteer in this clinical research study because you have been diagnosed with tricuspid valve regurgitation.

The type of research study you are being asked to join is called an Early Feasibility Study. This means the device and procedure you are receiving (the treatment) have not been previously studied in humans, and that you will be among the first patients in the world to undergo this treatment. The Device you are receiving is not approved by the United States Food and Drug Administration and its safety and effectiveness are unknown.

Participants will undergo right heart catheterizations, computed tomography (CT) scans without iodinated contrast, multiple ultrasounds of the heart, labs, and other assessments. The length of subject participation in the study is 5 years and includes 11 research visits. You will have a screening right heart catheterization (RHC) to check the pressures and function of your heart. The research procedure and placement of the TRIcares Topaz Transfemoral Tricuspid heart Valve (Topaz Tricuspid Valve) will be placed in a hybrid operating room. This procedure is done by entering a vein in your groin known as the femoral vein. The purpose of this device is to eliminate the regurgitation or leaking in the tricuspid valve of the heart to help reduce the symptoms caused by this leaky valve.

The most common risks associated with the research procedure are those related to the right heart catheterization (RHC) and Topaz Tricuspid valve procedure. Major risks include bleeding and damage to the heart or surrounding blood vessels. There are no known benefits of the research device. There may be possible benefits from the research procedure including improvement in quality of life or a decrease in the symptoms caused by tricuspid regurgitation. The information that we obtain from your participation in this study will help us learn more about how safe and effective this approach is in treating the symptoms of individuals similar to yourself.

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

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Amyloid Depleter ALXN2220 in Adult Participants with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Date Added
August 13th, 2024
PRO Number
Pro00138400
Researcher
Jan Griffin

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart
Summary

This study involves an investigational drug called ALXN2220 for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). Investigational means it is not yet approved for commercial use or sale by the Food and Drug Administration (FDA). ALXN2220 is intended to promote the elimination of ATTR deposits leading to symptom improvement.
All participants will be randomized, meaning assigned by chance, to receive ALXN2220 or placebo. A placebo looks like the study drug but contains no active medication. In this study, participants will have a 2 out of 3 chance, like drawing straws, of receiving the study drug and 1 out of 3 chance of receiving placebo. Neither the participants nor the study team or study doctor will know if they are assigned to receive the study drug or placebo. The study drug or placebo will be administered intravenously (IV), meaning into a vein in the arm, every four weeks.
Participation in this study will include a maximum of 56 visits over a maximum of 48 months. Study procedures include collection of vital signs, study drug infusion, physical exams, 12-lead electrocardiography, blood and urine collection, echocardiogram (ultrasound test of the heart), questionnaires, and some optional testing.

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

A phase 2, adaptive, double-blinded, placebo controlled, randomized, multi-center trial to evaluate the efficacy, safety and tolerability of intracoronary infusion of AB-1002 in adult subjects with New York Heart Association (NYHA) Class III heart failure and non-ischemic cardiomyopathy (GenePHIT)

Date Added
August 13th, 2024
PRO Number
Pro00138528
Researcher
Adrian Van Bakel

List of Studies


Keywords
Cardiovascular, Genetics, Heart
Summary

This study is evaluating the safety and effectiveness of the experimental treatment named AB-1002. The purpose of this study is to look at the safety and feasibility of delivery of adeno-associated virus (AAV) through the coronary arteries into the heart in participants with heart failure and non-ischemic cardiomyopathy. An experimental treatment is another option for care for your disease that is still being tested and is not yet approved by the Food and Drug Administration (FDA).

Participation in this study is expected to last one year and include up to 18 visits. Study related procedures include the following heart related testing: study drug infusion, electrocardiograms (ECG), a test to show the heart's electrical activity, echocardiogram (Echo), a test that uses ultrasound to capture moving images of the heart, cardiopulmonary stress test, sample collection including blood, urine, tissue, nasal mucus, saliva, semen, and stool, questionnaires, physical exams, and at least an overnight stay in the hospital. You will also need to take medications to suppress your immune system.

There are risks associated with this study. Risks associated with gene therapy include an immune response that may cause inflammation in the liver, heart or other organs. It may damage your red blood cells, cause a low platelet count or cause the formation of small blood clots. There are also risks related to the study procedures including bleeding associated with the heart biopsy, risks related to drawing blood, risks of radiation, and loss of confidentiality. There may be no benefit to you but knowledge gained from this study may benefit others with heart failure and non-ischemic cardiomyopathy in the future.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
8438765783
shr37@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and the Decline in Kidney Function in Participants with Body Mass Index ≥ 27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease

Date Added
June 25th, 2024
PRO Number
Pro00136763
Researcher
Sheldon Litwin

List of Studies


Keywords
Cardiovascular, Kidney, Obesity, Stroke Recovery
Summary

Individuals with obesity and a history of heart or kidney-related disease will be eligible for participation. Study participants will have a 50:50 chance to be randomly assigned to either the treatment (retatrutide) or control (placebo) group. Retatrutide is currently considered an investigational medication as it has not been approved by the FDA for the treatment of obesity or any other medical condition at this time. Study participation will last approximately 5 years and begin with a screening period to ensure correct patient selection. Research clinic visits will occur every 4 weeks initially and then every 12 weeks. Some visits may be completed virtually through telehealth or by phone. Study procedures include but are not limited to: blood draws, questionnaires, self injection of study medication, medical history review, vital signs, and electrocardiogram. The medication will be injected subcutaneously once a week. The medication's purpose is to facilitate weight loss and decrease a subject's risk for heart or kidney related disease progression or events.

Institution
MUSC
Recruitment Contact
Elhaam Borhanian
843-792-5873
borhania@musc.edu

Treatment In Thoracic Aortic Aneurysm: Surgery versus. Surveillance (TITAN:SvS)

Date Added
June 18th, 2024
PRO Number
Pro00129203
Researcher
Sanford Zeigler

List of Studies


Keywords
Cardiovascular
Summary

To undertake the first prospective randomized controlled trial that compares early aortic surgery to aneurysm surveillance.

The purpose of the study is to compare different treatment plans for patients with abnormal aortas. Patients who have an abnormal aorta measuring at least 5.5cm will have surgery to replace the aorta. We do not know, however, whether patients with abnormal aortas that are not quite 5.5cm should have surgery or should be monitored to see if their aorta continues to grow. Therefore, through this registry and interventional study, the hope is to collect more data on which treatment is better for the patient. The interventional group will undergo surgery to repair their abnormal aorta, and the surveillance group will be closely monitored and medically managed per standard of care. Both groups will have data collected from their care and at the end of the study this data will be analyzed. The goal of this study is to determine if performing surgery earlier helps to prevent abnormal aortas below 5.5cm from tearing or bursting.

Institution
MUSC
Recruitment Contact
Hannah Culpepper
8437927244
culpepph@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

A Follow-Up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)

Date Added
June 11th, 2024
PRO Number
Pro00137149
Researcher
Jessica Atkins

List of Studies

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

This study is for patients with hypertrophic cardiomyopathy (HCM). HCM is a condition where the heart muscle becomes abnormally thickened, which can sometimes block the blood flow out of the heart and results in the heart muscle working harder to pump blood to the body. Participants who have completed participation in a previous HCM study investigating the study drug, called aficamten (CK-3773274), will be eligible to participate in this study.

The study is done to collect long-term safety and tolerability data, including assessments of cardiac structure and function during chronic dosing with aficamten. Aficamten is a tablet taken by mouth. This is an open label study (the participants and study team will know the dose of aficamten taken at any given time). If your screening results show you are eligible to continue in the study, you will visit the research site for the "first dosing day" (Day 1), followed by visits at Weeks 2, 4, 6, 12, then every 12 weeks thereafter. Study related procedures include blood work, echocardiograms (ultrasound test of the heart), electrocardiogram (recording of heart's electrical activity), physical exams, and questionnaires. Risks associated with this study include shortness of breath, nausea, diarrhea, headaches and dizziness.

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



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