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 Save

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 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

Peri-operative Exposure to Plasticizers in Newborns Undergoing Cardiac Surgery Save

Date Added
March 18th, 2020
PRO Number
Pro00087955
Researcher
Eric Graham

List of Studies


Profiles_link
Keywords
Heart, Surgery
Summary

This is a prospective observational study which collects urine samples for testing. The goal of this study is to measure how much plastic from medical equipment shows up in the baby's urine.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
843-792-1213
choudhar@musc.edu

GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO): the REDUCE Post Approval Study Save

Date Added
February 25th, 2020
PRO Number
Pro00095864
Researcher
John Rhodes

List of Studies

Silhouette
Keywords
Heart
Summary

REDUCE study is researching the safety and effectiveness of GORE® CARDIOFORM Septal Occluder (GSO ) device in closing the patent foramen ovale (PFO) in patients who have a PFO and had a stroke of unknown origin (cryptogenic stroke). This device has been approved by the United States Food and Drug Administration for this indication.

A PFO is a common opening in the wall (septum) between the two upper chambers (the right and left atria) of the heart. In most cases, this opening closes around the time of birth. If the opening remains after birth, it can allow the blood to mix in the two upper chambers of the heart.

In most people, leaving the opening untreated has no negative consequences. However, in some patients who have had a stroke of unknown origin (cryptogenic stroke), the presence of a PFO may increase the risk of having another stroke if the opening is left untreated.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
843-792-1213
choudhar@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 Save

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

List of Studies


Profiles_link
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

A Multi-Institutional Neurocognitive Discovery Study (MINDS) in Adult Congenital Heart Disease (ACHD): MINDS-ACHD Save

Date Added
January 16th, 2020
PRO Number
Pro00085138
Researcher
John Rhodes

List of Studies

Silhouette
Keywords
Heart
Summary

This is a multicenter cross-sectional pilot analysis of objective and subjective neurocognitive deficits (NCD) and genetics in the Adults with Congenital Heart Disease (ACHD) population ages 18-30 years with moderate and severe complexity of congenital heart disease (CHD).

The expectation is that studying NCD in ACHD will help to guide access to resources and appropriate medical care for these patients. This research should facilitate the use of targeted interventions in the ACHD population with NCD to enhance both long term quality of care and quality of life (QOL).

Institution
MUSC
Recruitment Contact
Kalyan Chundru
843-792-1213
choudhar@musc.edu

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

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

List of Studies

Silhouette
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 Save

Date Added
October 16th, 2019
PRO Number
Pro00085562
Researcher
Ryan Tedford

List of Studies

Silhouette
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

A Randomized Controlled Trial Comparing Monitored Anesthesia Care versus General Anesthesia with Transesophgeal Echocardiography for Transcatheter Aortic Valve Replacement Save

Date Added
June 18th, 2019
PRO Number
Pro00088473
Researcher
George Whitener

List of Studies


Profiles_link
Keywords
Cardiovascular, Heart, Surgery
Summary

This study is being done to evaluate the impact that monitored anesthetic care (MAC) versus general endotracheal anesthesia (GETA) has on hospital length of stay, rate of ICU admission, or procedural mortality. Also, we hope to determine if the use of Transesophageal Echocardiography (TEE) during GETA impacts device success and durability. Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis may be eligible candidates for this study.

Institution
MUSC
Recruitment Contact
Wanda Jones
8437921869
joneswr@musc.edu

Pulmonary Hemodynamics during Exercise - Research Network Save

Date Added
May 16th, 2019
PRO Number
Pro00087395
Researcher
Ryan Tedford

List of Studies

Silhouette
Keywords
Cardiovascular, Heart
Summary

Elevated pressures in the heart can represent a severe medical condition known as pulmonary hypertension. This can result in chronic right heart failure. An abnormal increase in this pressure during exercise may be represent an early stage of vascular lung disease. This study will investigate the prognostic implications of the measured pressures obtained during exercise while undergoing a right heart catheterization procedure based on a large scale multi-center approach by using retrospective and prospective analysis of hemodynamic data.

Institution
MUSC
Recruitment Contact
Brandon Sykes
843-876-5873
sykesb@musc.edu

Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial Save

Date Added
March 26th, 2019
PRO Number
Pro00087159
Researcher
Jacqueline Kraveka

List of Studies


Profiles_link
Keywords
Cancer, Heart, Pediatrics
Summary

This study is for patients that are survivors of childhood cancer who received a type of treatment called anthracycline chemotherapy at a young age. The investigational drug in this study is carvedilol. Medications such as carvedilol have been shown to improve heart function and delay the onset of heart failure. However, carvedilol has not been studied in a large group of childhood cancer survivors who received anthracycline chemotherapy. The purpose of this study is to see if a two-year course of carvedilol in childhood cancer survivors to see if it will have the same effects as shown in these prior studies of people with mild heart failure or who were at risk for heart failure. People in this clinical trial are expected to receive treatment on this study for about 2 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Change_preferences

-- OR --

Create_login