Safety and Effectiveness of TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex SE) for the Treatment of Drug Refractory, Symptomatic, Paroxysmal Atrial Fibrillation (TactiFlex PAF IDE Trial)

Date Added
October 13th, 2020
PRO Number
Pro00101068
Researcher
Michael Field

List of Studies


Keywords
Cardiovascular, Heart
Summary

The purpose of this research study is to demonstrate that the TactiCath SE catheter is safe and effective for ablating (burning heart tissue using heat energy) your symptomatic, paroxysmal (starts and stops on its own) atrial fibrillation (irregular heart beat in upper chambers of heart) that is not effectively treated with medication. Participation in the study will last about 12 months from the time of the ablation procedure. Participants will be asked to complete follow-up visits at 7-days (phone call visit), 5 weeks (phone call visit) 3-months (in person visit), 6-months (in person visit), and 12-months (in-person visit). Data collected for this study will be submitted for review and approval by the U.S. Food and Drug Administration (FDA).

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

A Mixed Methods Approach to Symptom Clusters in Black Women with Heart Failure Preserved Ejection Fraction: A Feasibility Study

Date Added
August 7th, 2020
PRO Number
Pro00101261
Researcher
Alexandra Ruppe

List of Studies

Keywords
Cardiovascular, Ethnicity and Disease, Heart, Minorities, Non-interventional, Shortness of Breath, Women's Health
Summary

This study aims to explore symptoms for Black women with heart failure using surveys and interviews. Black women have not been included in the majority of heart failure research. It is important that Black women have a voice and the ability to share their symptom experience. The goal of this research is to study clusters of heart failure symptoms in Black women to eventually improve symptom education, monitoring, and treatments.

Institution
MUSC
Recruitment Contact
Alexandra Ruppe
8034176635
moseleal@musc.edu

Multicenter Study Into Individualized Scanning for Coronary Artery Disease (MINDS-CAD)

Date Added
July 14th, 2020
PRO Number
Pro00100282
Researcher
Uwe O.P. Schoepf

List of Studies


Keywords
Cardiovascular, Coronary Artery Disease
Summary

This study uses CT scans to visualize the heart and surrounding arteries to look for coronary artery disease. This study takes into account individuals body type including size, weight, and heart rate to tailor the CT scan and contrast media given to each patient. Taking into account each patients body will allow doctors to obtain the best image possible while reducing the amount of contrast media given to patients.

Institution
MUSC
Recruitment Contact
Hunter Gray
8438764922
grayhu@musc.edu

SUPERIOR VENA CAVAL OCCLUSION IN SUBJECTS WITH ACUTE DECOMPENSATED HEART FAILURE - AN EARLY FEASIBILITY STUDY

Date Added
June 9th, 2020
PRO Number
Pro00096629
Researcher
Ryan Tedford

List of Studies


Keywords
Cardiovascular
Summary

This study is an early feasibility study which typically consist of evaluating innovative devices or innovative uses of approved devices. The purpose of this study is to see if an investigational device called preCARDIA Intermittent Balloon Device can limit fluid overload in congested patients with advanced heart failure. This investigational device is a catheter which has been approved by the U.S. Food and Drug Administration (FDA) to occlude large vessels but not for the treatment of advanced heart failure. Currently, there are no device-based approaches that are FDA-approved for advanced heart failure. This study will help find out if this device-based approach can improve symptoms and heart function in congested patients with advanced heart failure

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
8437920464
panneeer@musc.edu

OPEN-LABEL EXPLORATORY STUDY OF ORAL MYK-491 IN STABLE AMBULATORY PATIENTS WITH PRIMARY DILATED CARDIOMYOPATHY DUE TO EITHER MYH7 OR TTN VARIANTS

Date Added
April 14th, 2020
PRO Number
Pro00095947
Researcher
Daniel Judge

List of Studies


Keywords
Cardiovascular, Genetics
Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (the levels of drug in the blood) and pharmacodynamics (the effect of the drug on your body) of the study drug, MYK-491, when administered orally twice a day for about one to two weeks.The study will recruit patients with an enlarged heart and weakened heart muscle not caused by heart damage from a heart attack or heart valve problem. Eligible patients must also have a specific genetic mutation called MHY7. All subjects that qualify will receive MYK-491 (no placebo, or inactive pill will be dispensed during the study). The study medication is designed to improve cardiac contractility or the ability of the heart to squeeze.

This study has two treatment periods during which multiple doses of MYK-491 (the study drug) will be administered. Once Treatment Period 1 is completed, participants will return to the clinical site for study assessments and to obtain a dose for Treatment Period 2. The investigator will review the results of the study assessments and participants will learn if they will receive a lower or higher dose of MYK-491 for Treatment Period 2 than they received in Treatment Period 1. The expected study duration ranges from about 4 weeks to 11 weeks, including about 1-8 weeks for screening, 9 to 15 days for IMP dosing and an approximately 1 week (7±1 days) follow-up visit.

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

Design and Rationale of the assessment of the Mindmics recording system to collect data to facilitate the development of an algorithm to discriminate atrial fibrillation from sinus rhythm

Date Added
March 24th, 2020
PRO Number
Pro00096535
Researcher
Francis Gilliam

List of Studies

Keywords
Cardiovascular, Heart
Summary

We will recruit patients with atrial fibrillation during office visits, inpatient admission, and at time of elective direct current cardioversions.

We will record 15 minutes of ECG data and data from the Mindmics earbuds during office visit or prior to and after cardioversion.

We will use the recorded data to formulate algorithms to discern atrial fibrillation from normal sinus rhythm.

Institution
Palmetto
Recruitment Contact
Francis Gilliam
8035531321
Rosey.gilliam@prismahealth.org

Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms

Date Added
March 24th, 2020
PRO Number
Pro00096973
Researcher
Richard Bayer

List of Studies


Keywords
Cardiovascular, Heart
Summary

The Revivent TC System study is being conducted to test an investigational device that can repair a Left Ventricular Aneurysm without the use of a heart-lung machine, or opening the chest/heart chamber. The device works by placing a tuck in the heart where there is scar, which has the effect of shortening the distance across the heart and decreasing the tension, or stress, on the working heart muscle. The device consists of several implants, called anchors. The anchors are placed during a surgery in which your doctors will access your heart by placing a guide wire through a vein in your neck into your heart and also through an incision in your chest wall between your ribs on your left side. The anchors will help reshape your heart muscle by tucking in the scarred area. It is expected that the total study duration will be approximately 6 years, consisting of 1 year of patient enrollment and 5 years of patient follow-up.

Institution
MUSC
Recruitment Contact
Deborah Everidge
8437922244
adamsde@musc.edu

PIVOTAL EVALUATION OF THE ACCESS NATRIURETIC PEPTIDE ASSAY(S) AS AN AID IN THE DIAGNOSIS AND ASSESSMENT OF SEVERITY OF ACUTE HEART FAILURE – EMERGENCY DEPARTMENT SUBJECT ENROLLMENT AND SPECIMEN COLLECTION

Date Added
February 17th, 2020
PRO Number
Pro00095805
Researcher
Gary Headden

List of Studies


Keywords
Cardiovascular, Heart
Summary

This is a prospective, multicenter clinical trial for individuals presenting to the Emergency Department with suspicion of acute heart failure. A blood sample collected will be used to compare the standard of care BNP test used at the local site to the investigational assay from Beckman Coulter (sponsor).

The diagnosis and treatment of patients at each site will use an FDA-cleared BNP or NT-proBNP assay under the site's standard of care and NOT the investigational assay.

Institution
MUSC
Recruitment Contact
Annelise Kauffman
843-792-3576
kauffmaa@musc.edu

RELIEVE-HF TRIAL: REducing Lung congestIon symptoms using the v-wavE shunt in adVancEd Heart Failure

Date Added
January 14th, 2020
PRO Number
Pro00095660
Researcher
Sheldon Litwin

List of Studies


Keywords
Cardiovascular, Heart, Hypertension/ High Blood Pressure
Summary

The purpose of the study is to evaluate the safety and how well the V-Wave Interatrial Shunt works. The study will also look at information obtained from the tests performed to see if subjects have improvement in symptoms of heart failure. Participation in this study will last approximately 1 year to up to 7 years depending on randomization group. During the study period subjects will be asked to attend regular study visits with the research coordinator. These visits will include such activities as blood tests, questionnaires, physical evaluation by a study doctor, echocardiogram, and 6 minute hall walks. There will be a minimum of 10 or up to 15 planned research clinic visits. Subjects will have 1 overnight hospital stay for the study related RHC and research procedure. Each participant will receive a phone call between all study visits.

Subjects will have a 50:50 chance of receiving the Shunt during the randomization procedure (like the flip of a coin). Neither the subject, nor the blinded study doctor or blinded study coordinator will know which group subjects are in. Participants will be randomized to either the treatment group (and receive the Shunt) or the control group (and not receive the shunt). Neither the subject nor the study doctor will decide what group subjects are assigned.

Institution
MUSC
Recruitment Contact
Renee Baxley
843-792-1105
baxleyr@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



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