A Randomized Controlled Clinical Evaluation of the DiamondTemp™ System for the Treatment of Paroxysmal Atrial Fibrillation Save

Date Added
November 28th, 2017
PRO Number
Pro00072395
Researcher
Frank Cuoco

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Keywords
Cardiovascular, Heart
Summary

The purpose of this clinical study is to see whether a medical device called the DiamondTemp Ablation Catheter (also called the DiamondTemp Ablation System) can restore the heart to a normal heart rhythm.The DiamondTemp Ablation System being evaluated in this research study is investigational because it is not approved by the FDA for the treatment of atrial fibrillation by radiofrequency ablation. The DiamondTemp System is like systems currently being used to treat atrial fibrillation with radiofrequency ablation including the control system that participants could be randomized to.

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

Development of CSD-Based Therapies: Novel Indications and Improved Versions of CSD Save

Date Added
September 26th, 2017
PRO Number
Pro00069613
Researcher
Stanley Hoffman

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Keywords
Heart, Lung, Lupus, Scleroderma
Summary

We have already observed that the blood cells known as monocytes from patients with the fibrotic disease scleroderma behave differently from monocytes from healthy controls. Here we will test whether patients with other fibrotic diseases also have altered monocyte function. Specifically, we will get blood from congestive heart failure and lupus patients and compare their monocytes to scleroderma patient and healthy subject monocytes. Our recent results in a mouse model for congestive heart failure suggest that we will find altered monocyte behavior in human congestive heart failure patients.

Institution
MUSC
Recruitment Contact
Elena Tourkina
843-792-7319
tourkine@musc.edu

REVAMP Study (REmodeling the Left Ventricle with Atrial Modulated Pacing) Save

Date Added
August 8th, 2017
PRO Number
Pro00067879
Researcher
Sheldon Litwin

Silhouette
Keywords
Heart
Summary

The REVAMP Clinical Study is a feasibility study in heart failure with preserved ejection fraction (HFpEF) patients who have normal to small left ventricular volumes and evidence of hypertrophy. The pacemaker Sleep function will be used in order to deliver a 5 hour block of sustained pacing at 100 bpm during the night for 4-8 weeks. The purpose is to investigate whether this elevated pacing therapy is tolerated and whether there is a signal of efficacy.

If tolerated the idea is that this will promote LV dilation, which will reduce stiffness in the heart and improve diastolic filling in HFpEF patients that have thickened ventricular walls.

Institution
MUSC
Recruitment Contact
Kayla Moses
843-792-5873
moseska@musc.edu

Validation of the Palliative Performance Scale to predict survival of older adults admitted to the hospital from the Emergency Department. Save

Date Added
August 4th, 2017
PRO Number
Pro00063739
Researcher
Leigh Vaughan

Silhouette
Keywords
Cancer, Dementia, Heart, Kidney, Liver, Pulmonary, Stroke
Summary

The Palliative Performance Scale has been shown to predict survival among hospice and palliative medicine patients in the outpatient and inpatient clinical settings, where lower PPS scores are directly related to shorter survival. We seek to evaluate if this relationship persists among a racially diverse, older adult population when assessed at the time of admission from the emergency department.

Institution
MUSC
Recruitment Contact
Jonas Te Paske
8432597649
tepaske@musc.edu

Hemodynamic Effects of Cardiac Resynchronization Therapy (CRT) on Subjects with Left Ventricular Assist Devices (LVADs) Save

Date Added
July 18th, 2017
PRO Number
Pro00067689
Researcher
Brian Houston

Silhouette
Keywords
Cardiovascular, Heart
Summary

For some patients with heart failure, we know that using a special pacemaker configuration called cardiac resynchronization therapy (CRT) can help them feel better and live longer. In fact, in these patients, we can see improvements in cardiac function with CRT as early as a few beats after we turn it on. However, some patients continue to be sick after CRT and ultimately require more help. Some of these patients will get a surgically implanted pump (called a left ventricular assist device, or LVAD) that does the work of their heart. We do not know if CRT continues to help (or may hurt) these patients. In this study, we will assess the effects of CRT in LVAD patients in the short term.

Institution
MUSC
Recruitment Contact
Brian Houston
843-876-4787
houstobr@musc.edu

CardioMEMS HF System Post Approval Study Save

Date Added
July 17th, 2017
PRO Number
Pro00062661
Researcher
Daniel Steinberg

Silhouette
Keywords
Cardiovascular, Heart
Summary

This is a prospective, multi-center, open-label trial conducted in the United States (US). The study is designed to collect real world data on subjects with heart failure who are receiving the CardioMEMS HF System. The CardioMEMS is an approved medical device. The CardioMEMS device is designed to provide current measurements of a specific heart pressure to physicians. This information will help guide medical therapy in order to help prevent heart failure hospitalizations.

Institution
MUSC
Recruitment Contact
Laura Waters
843-876-8921
waters@musc.edu

Heart Failure in Single Right Ventricle Physiology: Pathologic Mechanisms and Novel Assessment Save

Date Added
July 5th, 2017
PRO Number
Pro00066472
Researcher
Shahryar Chowdhury

Silhouette
Keywords
Cardiovascular, Children's Health, Heart, Pediatrics
Summary

The goals of this study are to understand the mechanisms behind the development of heart failure in children born with complicated heart defects consisting of a functional single pumping chamber, improve the ability to objectively measure cardiac function in these patients and determine the relationship of these pathophysiologic mechanisms to outcomes.

Institution
MUSC
Recruitment Contact
Christine Perez-Rosa
843-792-9454
perezaro@musc.edu

REDUCE LAP-HF RANDOMIZED TRIAL II: A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure Save

Date Added
May 9th, 2017
PRO Number
Pro00065245
Researcher
Sheldon Litwin

Silhouette
Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to evaluate the potential effectiveness, outcomes, and safety (before, during, and after study procedures) of the investigational device in the treatment of subjects with heart failure symptoms and relatively normal pumping of the heart. The device is called the IASD system II and it is permanently implanted in the heart to reduce in the increased pressure by creating a small opening between the two upper chambers of the heart. It will be a randomized, single blind (subject) trial. Subjects will be followed for two years and then annually for 3 years for a total of 5 years after implantation.

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

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging, Phase 2b Study of the Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of BMS-986231 in Hospitalized Patients with Heart Failure and Impaired Systolic Function Save

Date Added
March 28th, 2017
PRO Number
Pro00063152
Researcher
Adrian Van Bakel

Silhouette
Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to evaluate the safety, and effectiveness of BMS-986231 (HNO DONOR) in patients with acute heart failure when added to the standard treatment. Reduced strength of contraction can mean that your heart is not pumping most of the blood out of your heart with each beat. The study drug will be given as a continuous 48-hour infusion (through an IV) during the hospital stay. There will be a follow up visit at 30 days. All adults who meet inclusion criteria will be approached for this study.

Institution
MUSC
Recruitment Contact
Anna Tecklenburg
8437925863
tecklenb@musc.edu

Lymphangiogenesis Factors in Heart Failure States (LYFT-HF study) Save

Date Added
February 21st, 2017
PRO Number
Pro00062457
Researcher
Brian Houston

Silhouette
Keywords
Cardiovascular, Heart
Summary

Heart failure often causes fluid to accumulate in the body, leading to congestion and swelling. However, some people who have had heart failure for a long time seem to have very little congestion or swelling, even when the heart failure is poorly treated. We think that this is because lymphatic vessels are able to grow and remove fluid to prevent congestion. We do not know how lymphatic vessels grow. This study will investigate the blood levels of various proteins to see if we can figure out how the lymph vessels of people with long-standing heart failure might grow.

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

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