Seroprevalence Study of Pre-existing Antibodies Against Adenovirus-associated Virus Vector (AAV) in Patients with Plakophilin 2 (PKP2)-associated Arrhythmogenic Right Ventricular Cardiomyopathy(ARVC)

Date Added
January 5th, 2024
PRO Number
Pro00132416
Researcher
Daniel Judge

List of Studies


Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to collect information about patients with Arrhythmogenic right ventricular cardiomyopathy(ARVC) and about the disease. ARVC is a rare condition that affects heart muscle and causes abnormal heart rhythms (this is called "arrhythmia"). Participation in this study will take about 5 years. If your study doctor determines you are eligible and you agree to participate, you will be asked to visit the study doctor's office as part of your regular care for a screening visit and about 1 time each year for the length of the study. The majority of the data collected for this study will be part of your regular care, however study related procedures include arrhythmia monitoring, using wearable devices to measure tracing of the electrical activity of your heart, blood work, including genetic testing, and patient questionnaires

Institution
MUSC
Recruitment Contact
Sam Moody
843-876-9558
moodysa@musc.edu

Abbott Ventricular Tachycardia Post Approval Study

Date Added
October 24th, 2023
PRO Number
Pro00132390
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Cardiovascular
Summary

This study is enrolling subjects who are scheduled for a ventricular tachycardia (VT) ablation. Ventricular tachycardia is a fast heartbeat that starts with an abnormal signal in the lower chambers of the heart, which are the ventricles. An ablation is a procedure where a catheter (thin, flexible tube) with a tip that can deliver energy is used to burn the heart tissue where those abnormal signals are coming from. The catheter being used in this study is called the FlexAbilityTM Ablation Catheter and was recently approved for commercial use by the Food and Drug Administration. (FDA) Since it is newly approved, the FDA wants to continue collecting more information about the catheter and its use, so this study is called a post approval study. Participation in this study will take about 1 year. During this year, data will be collected including your medical history, cardiac medication use, ablation procedure, and any medical events that may occur. You will be seen or contacted 4 times. There is a risk of loss of confidentiality and there may be risks that are not yet known. There may be no direct benefit to you but it is hoped the information learned may contribute to knowledge in this field.

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

Fontan Udenafil Exercise Longitudinal Assessment Trial (the FUEL-2 Study)

Date Added
October 2nd, 2023
PRO Number
Pro00130325
Researcher
Andrew Atz

List of Studies


Keywords
Adolescents, Cardiovascular, Drug Studies, Pediatrics
Summary

This will be a 26-week, prospective, multicenter, randomized, double-blind, placebo-controlled safety and efficacy study of udenafil 87.5 mg tablets versus placebo (both taken twice daily in adolescent subjects who have had the Fontan procedure. The primary efficacy endpoint will be change from baseline at 26 weeks in peak minute oxygen consumption [VO2] (mL/kg/min).

Institution
MUSC
Recruitment Contact
Susannah Wakefield
843-792-8317
wakefies@musc.edu

A Phase 3, Multi-center, Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy

Date Added
September 12th, 2023
PRO Number
Pro00131432
Researcher
Jessica Atkins

List of Studies

Keywords
Cardiovascular, Heart
Summary

This study is for patients with obstructive hypertrophic cardiomyopathy (oHCM). oHCM 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.

The study is done to compare the side effects and effectiveness of an investigational (not yet approved by the Food and Drug Administration (FDA)) medication with the beta-blocker metoprolol succinate in participants with oHCM. The study medication is known as Aficamten and is a tablet taken by mouth. This is a randomized study (participants will be assigned by chance to the study medication Aficamten and placebo or metoprolol succinate and placebo). A placebo looks just like the study medication but has no active ingredient in it. The medications will be administered in the form of a pill. This study will take about 9 months and include about 11 visits to the study site. Study related procedures include blood work, echocardiograms (ultrasound test of the heart), electrocardiogram (recording of heart's electrical activity), exercise testing, physical exams, questionnaires and optional genetic testing. Risks associated with this study include shortness of breath, nausea, diarrhea, headaches and dizziness.

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

LIBREXIA - AF A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants with Atrial Fibrillation

Date Added
August 15th, 2023
PRO Number
Pro00130569
Researcher
James Phillips

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart, Vascular
Summary

This is a study comparing the new class anticoagulants factor XIa to the FDA approved Apixaban. The study is to determine if Milvexian is as effective and safe with preventing clots for patients with A-fib and to determine if Milvexian is better at reducing the chances of bleeding.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Jacqueline Sheriod-Scott
1-803-255-2927
sheriods@musc.edu

LIBREXIA - AF A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants with Atrial Fibrillation

Date Added
August 15th, 2023
PRO Number
Pro00130569
Researcher
James Phillips

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart, Vascular
Summary

This is a study comparing the new class anticoagulants factor XIa to the FDA approved Apixaban. The study is to determine if Milvexian is as effective and safe with preventing clots for patients with A-fib and to determine if Milvexian is better at reducing the chances of bleeding.

Institution
MUSC Heart and Vascular Institute
Recruitment Contact
Jacqueline Sheriod-Scott
1-803-255-2927
sheriods@musc.edu

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

The Rhythm Evaluation for Anticoagulation with Continuous Monitoring of Atrial Fibrillation

Date Added
May 23rd, 2023
PRO Number
Pro00128438
Researcher
Rachel Kaplan

List of Studies

Keywords
Cardiovascular
Summary

This research is being done to assess whether it is safe and effective to stop oral anticoagulation medications (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF).

You may qualify for this study if you have a history of atrial fibrillation (AF) and are currently taking an oral anticoagulant (a blood-thinning medication). You will be randomized to one of two groups: Control Group or Study Intervention Group.

If you are randomized to the Control group, you will be asked to stay on your previously prescribed oral anticoagulant. If you are randomized to the Study Intervention group, you will be asked to take the oral anticoagulant for 30 days only if a prolonged episode of AF is detected on an AF-sensing Apple smartwatch you will be provided.

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

BIO-CONDUCT Study BIOTRONIK Conduction System Pacing with the Solia Lead

Date Added
April 11th, 2023
PRO Number
Pro00127714
Researcher
Anne Kroman

List of Studies

Keywords
Cardiovascular, Heart
Summary

This study is enrolling subjects who need a pacemaker implant for a heart rhythm disorder. A pacemaker is a device implanted under the skin in the upper chest, and is designed to send electrical signals to tell the heart to squeeze (contract) through wires called leads. A conventional pacemaker has a lead placed in the right ventricle (lower chamber of the heart) which is referred to as ventricular pacing. This study will investigate conduction system pacing which is pacing from the part of the ventricle that normally carries electricity through the heart. The specific name for this part of the ventricle is the left bundle branch block area. The heart's conduction system initiates impulses that tells the heart muscle to contract in a coordinated fashion. This study will use the Solia S lead, which is considered investigational, meaning it is not yet approved by the Food and Drug Administration (FDA) for conduction system pacing. The Solia S lead is approved for ventricular pacing.

Participation in this study will last about one year and include 4-5 visits, some of which may be done virtually. The study involves collecting data from your pacemaker implant, Solia S placement, completing questionnaires, electrocardiogram, medical history and medications.

Risks include those associated with the pacemaker implant procedure such as potentially longer implant time, a tear in the interventricular septum (the wall separating the lower chambers of the heart) or unsuccessful lead placement. Other study related risks may include the risk of loss of confidentiality, risks of answering a questionnaire or unknown risks. There may be no benefit to you but the information learned may benefit others in the future who need conduction system pacing.

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

Pediatrics Biorepository to Support Cardiology Clinical Research

Date Added
April 9th, 2023
PRO Number
Pro00124741
Researcher
Eric Graham

List of Studies


Keywords
Cardiovascular, Heart
Summary

This proposal is to contribute to data registry and sample bank called Pediatrics Biorepository for Cardiology Clinical Research. Samples collected in this study may be used for future research which plan to advance the state of science in the hopes to develop new ways to diagnose and treat children affected with heart conditions.

Institution
MUSC
Recruitment Contact
Eric Graham
843-792-9570
grahamem@musc.edu



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