Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Save

Date Added
September 26th, 2017
PRO Number
Pro00069122
Researcher
John Sturdivant
Keywords
Cardiovascular
Summary

The purpose of this research study is to evaluate the different ways to program a Cardiac Resynchronization Therapy Defibrillator (CRT-D) through the use of software built into the CRT-D system. A CRT-D does not cure heart failure, but many people who receive a CRT device notice that they feel better. The objective of the device programming required by the SMART CRT study is to provide heart failure therapy which improves heart function.

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

Research Trial for Optimized Nonenhanced 3T QISS MR Angiography of the Peripheral Arteries Save

Date Added
August 17th, 2017
PRO Number
Pro00070277
Researcher
Uwe o.p. Schoepf
Keywords
Cardiovascular, Vascular
Summary

The purpose of this study is to evaluate the use of a non-contrast MRI for the assessment of the vasculature of the lower extremity anatomical regions. Patients eligible for this study must have been referred for a clinical contrast enhanced CT scan or an invasive catheter angiography. The overall image quality and diagnostic accuracy of the non-contrast MRI will be compared to current clinical standards of care, such as contrast enhanced MRI, CT, and invasive angiography.

Institution
MUSC
Recruitment Contact
Brian Jacobs
843-876-4922
Jacobsbr@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
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
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
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

Apixaban for the Reduction of Thrombo-Embolism in patients with Device-Detected Sub-Clinical Atrial fibrillation Save

Date Added
June 27th, 2017
PRO Number
Pro00067386
Researcher
Michael Gold
Keywords
Cardiovascular
Summary

The purpose of this study is to determine which treatment is best for preventing stroke or systemic embolism in patients who have experienced at least one episode of SCAF (sub-clinical atrial fibrillation) detected by their pacemaker or ICD (intracardiac defibrillator) or ICM (insertable cardiac monitor) and also have other risk factors for stroke. Subjects will be randomly assigned to one of the two treatment strategies: apixaban or aspirin. Neither the subject nor the researcher will know which treatment the subject is assigned. Follow-up visits will occur every six months until the end of the study.

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

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction Save

Date Added
June 13th, 2017
PRO Number
Pro00065900
Researcher
Brian Houston
Keywords
Cardiovascular
Summary

The purpose of this study is to find out more about how an investigational study drug called omecamtiv mecarbil, works in people with heart failure. Omecamtiv mecarbil is also known as AMG 423. Omecamtiv mecarbil is an investigational medicine that increases the heart?s ability to pump. In this study, omecamtiv mecarbil will be compared to placebo.

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

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFECTS OF BEMPEDOIC ACID (ETC-1002) ON THE OCCURRENCE OF MAJOR CARDIOVASCULAR EVENTS IN PATIENTS WITH, OR AT HIGH RISK FOR, CARDIOVASCULAR DISEASE WHO ARE STATIN INTOLERANT Save

Date Added
February 28th, 2017
PRO Number
Pro00062003
Researcher
James Thomas
Keywords
Cardiovascular, Cholesterol
Summary

Research study looking for participants with, or at high risk for, cardiovascular disease (CVD). This study is being carried out to see if a new investigational drug called bempedoic acid provides cardiovascular benefits and decreases the risks of future cardiac events when taken by patients who are not able to take a type of medication called statins. The study may require up to 15 visits to the clinic over a period of five years.

Institution
MUSC
Recruitment Contact
Della MacNicholas
843-876-5012
macnichd@musc.edu

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