A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Heart Valve System in the Treatment of High Surgical Risk Patients with Symptomatic, Severe Aortic Regurgitation (AR)

Date Added
December 14th, 2021
PRO Number
Pro00116082
Researcher
Nicholas Amoroso

List of Studies


Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System in a patient population with symptomatic severe Aortic regurgitation ( a condition where the heart's aortic valve does not close tightly and allows some blood to leak back into the heart chamber) requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR).

Your involvement in this study will last approximately 5 years from the time of your procedure. The visits include: Screening/Baseline, Procedure, Pre-Discharge, 1 month, 6 months and annualy for 5 years

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

Quidel Corporation / High Sensitivity Near Patient Cardiac Troponin (High Note)

Date Added
December 8th, 2021
PRO Number
Pro00115891
Researcher
Gary Headden

List of Studies


Keywords
Cardiovascular
Summary

The purpose of this research study is to help detect a heart attack by measuring a protein called troponin. A company named Quidel is sponsoring a research study to see how a blood test that they make helps to diagnose heart attacks.

Institution
MUSC
Recruitment Contact
Aja Bayo
18437927944
bayo@musc.edu

Surveillance and Alert-Based Multiparameter Monitoring to Reduce Worsening Heart Failure Events- SCALE-HF 1

Date Added
November 18th, 2021
PRO Number
Pro00116583
Researcher
Priya Kumar

List of Studies

Keywords
Cardiovascular, Heart
Summary

This study utilizes data from the Bodyport Scale to develop an index that allows for the early detection of worsening heart failure. Participants will receive training on how to use Bodyport Scale and will complete remote follow-up visits. Researchers will look at medical records for heart failure history and any clinical events related to heart failure.

Institution
Self Regional
Recruitment Contact
Erin Wallace
864-943-2416
erin.smith@selfregional.org

Early Feasibility Study of the Edwards SAPIEN 3 System with the Edwards Caval Prestent for the Treatment of Reverse Caval Flow

Date Added
November 9th, 2021
PRO Number
Pro00116089
Researcher
Nicholas Amoroso

List of Studies


Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to evaluate if the Edwards SAPIEN 3 System with Edwards Caval Prestent (study device) can help treat patients with your symptoms (symptomatic heart failure patients with signs of excessive fluid retention) resulting from reverse caval flow (blood flowing backwards instead of forward to your lungs).

The type of research study you are being asked to join is called an Early Feasibility Study. Prior clinical studies have not been conducted for the study device and its safety and effectiveness are unknown. This means the study Device you are receiving has not been previously studied in humans, and that you will be among the first subjects in the world to undergo this treatment. The study device is considered investigational and not approved for commercial sale by the US Food and Drug Administration (FDA). The study device will be placed in the section of your inferior vena cava (IVC) (the major vein that brings oxygen-poor blood from the lower body back to the heart) below your heart and above the veins in your liver via a vein in your thigh.

The clinical benefits of using the study device for treatment of your condition is not well known at this time. Some possible benefits that may occur from use of the study device may include:
relief of symptoms related to heart failure including but limited to, improved fluid retention,
quality of life, and/or improvement in morbidity (illness or disease) and mortality (death).

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

Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect (ASCENT ASD STUDY)

Date Added
September 17th, 2021
PRO Number
Pro00111553
Researcher
John Rhodes

List of Studies


Keywords
Cardiovascular
Summary

Transcatheter closure of secundum ASD using a permanent implant is considered the standard of care for treatment of clinically significant ASD. Over the past twenty years, devices have evolved such that safety and effectiveness are equal or superior to surgical techniques while reducing the economic and psychological costs of care. Industry sources estimate that, globally, over half a million patients have received a septal occluder to treat atrial level shunts.

A key remaining drawback to all such devices is that they are permanent implants placed in a typically young population. Unlike surgical suture, which resorbs over time, all currently available septal occlusion implants are constructed with a metal framework that incorporates some amount of fabric-based material.

The reSept ASD Occluder is unique in that the framework of the implant is comprised of a bioresorbable material (PLGA) and is intended for use in patients with a clinically significant secundum ASD, who, in the judgment of their physician, require closure of the ASD and in whom a transcatheter approach is deemed appropriate.

Institution
MUSC
Recruitment Contact
Megan Bickford
843-876-3394
bickfome@musc.edu

Clinical Evaluation of the i-STAT hs-TnI Test to Aid in the Diagnosis of Myocardial Infarction (MI)

Date Added
August 3rd, 2021
PRO Number
Pro00110711
Researcher
Gary Headden

List of Studies


Keywords
Cardiovascular, Coronary Artery Disease, Heart
Summary

Troponin I (cTnI) is a protein that is found in the heart muscle. When someone has a heart attack or other injury to the heart muscle, increased levels of cTnI can be measured in the blood and testing for cTnI in blood is used to help diagnose a heart attack and other heart conditions.

Institution
MUSC
Recruitment Contact
Aja Bayo
843-792-7944
bayo@musc.edu

A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM)

Date Added
June 8th, 2021
PRO Number
Pro00110317
Researcher
Daniel Judge

List of Studies


Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to evaluate the safety and effectiveness of ION-682884 and determine if it can help people with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) which is a disease caused by change in a protein called transthyretin (TTR). ION-682884 is an investigational drug. "Investigational" means that ION-682884 is not yet approved for use in any settings outside of clinical research studies like this one and is considered experimental. ION-682884 has been shown to reduce the level of TTR in the blood of animals and healthy volunteers tested to date. Reducing the amount of TTR in your blood may reduce the amount of amyloid deposits in your body and may keep your cardiomyopathy from getting worse over time. However, it is not known if ION-682884 will help your cardiomyopathy.

If you meet the requirements and agree to participate in this study, you will receive subcutaneous (under the skin) injections of either ION-682884 or placebo once every 4 weeks from week 1 through week 117.
Your participation in this study will last approximately 36 months and will consist of clinic visits and follow up visits at home.

Institution
MUSC
Recruitment Contact
Hannia Ramos
843-876-4806
ramosha@musc.edu

Behavioral Activation Delivered via Home-based Telehealth to Improve Functioning in Cardiovascular Disease Patients Recently Discharged from Inpatient Care

Date Added
June 1st, 2021
PRO Number
Pro00110159
Researcher
Ronald Acierno

List of Studies

Keywords
Cardiovascular, Depression, Mental Health, Military
Summary

Patients with cardiovascular disease (CVD) are at increased risk of depression following hospital discharge. Unfortunately, most depressed CVD patients do not receive appropriate care for their depression, often because they are unable to, or are fearful of traveling to providers for the regimen of 8-12 weekly visits of therapy such as Behavioral Activation (BA). This study will compare the effectiveness of BA for depression, delivered via Telehealth, to standard post-CVD hospital discharge best practices. It is predicted that patients who receive BA will have better mental health outcomes and will be less likely to be re-hospitalized compared to patients who receive standard post-discharge care.

Institution
MUSC
Recruitment Contact
Stephanie Hart
843-789-6519
zeigls@musc.edu