Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)

Date Added
February 9th, 2021
PRO Number
Pro00104312
Researcher
Daniel Steinberg

List of Studies


Keywords
Heart, Surgery
Summary

This study is being done on patients who have heart failure, a condition where the heart muscle weakens and enlarges and cannot pump blood effectively. The purpose of this study is to assess the safety and effectiveness of a new device called the AccuCinch Ventricular Restoration System and compare it to treatment with standard heart failure medications alone. The AccuCinch Ventricular Restoration System consists of anchors, which attach to your heart muscle, sliders to connect the anchors and a thread like cord that goes through the anchors and is cinched to make your enlarged heart smaller so it can pump more efficiently. The device is implanted in one of the lower pumping chambers of the heart (called left ventricle). The study will have two groups, the treatment group in which participants undergo the device implant in addition to taking heart failure medications and the control group in which participants are treated with heart failure medications alone. Participation will last up to 5 years.

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

AcQMap® US Registry of Procedural and Long-term Clinical Outcomes (Discover-US)

Date Added
January 22nd, 2021
PRO Number
Pro00104331
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Heart
Summary

This study is collecting data on patients who are having an ablation procedure to correct an irregular heart beat called an arrhythmia. During this procedure an electrical map is made so your doctor can see where the irregular signals are located in your heart. The electrical mapping system called AcQMap®. After creating the electrical map your doctor will perform an ablation, which is a procedure where the irregular signals are burned with an ablation catheter. The catheter, a long, thin tube that enters at an artery in your groin area and is directed to your heart. The end of the catheter is able to burn tissue on contact. Your physician will use this catheter to burn the areas in your heart where the irregular heart beats start. This study will collect data from just before your ablation up to 3 years.

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

An Exploratory, Open-label, Proof-of-concept, Phase 2a Study of Mavacamten (MYK-461) in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF) and Chronic Elevation of Cardiac Troponin I and/or NT-proBNP

Date Added
January 12th, 2021
PRO Number
Pro00104968
Researcher
Sheldon Litwin

List of Studies


Keywords
Heart, Shortness of Breath
Summary

Volunteers are being asked to participate in a clinical research study to find out if the drug mavacamten is safe and effective in treating elevated biomarker levels that occur in patients who have Heart Failure with Preserved Ejection Fraction (HFpEF). HFpEF is a syndrome that leads to stiffening in the left bottom chamber of the heart. This stiffening makes it difficult for the chamber to relax enough to fill up with blood, leading to increased pressure inside of the heart. MyoKardia is doing this research to find out if the new medication called mavacamten will work and be safe for the treatment of heart failure patients with the elevated levels the biomarkers NT-proBNP (a marker of wall stress inside the heart) and/or cardiac troponin (a marker of heart muscle injury). Biomarkers are biological molecules found in bodily fluids that can indicate abnormal conditions within the body. The study is planned to go on for about 2 years and include 35 patients from about 30 different study sites.

Institution
MUSC
Recruitment Contact
Melissa Lamicq
843-876-5783
lamicq@musc.edu

Hemodynamic Effects of Pacing at Higher Rates in Subjects Recently Implanted with Durable Left Ventricular Assist Devices (LVADs)

Date Added
December 15th, 2020
PRO Number
Pro00103747
Researcher
Ryan Tedford

List of Studies


Keywords
Heart
Summary

Participants in this study will undergo a series of adjustments to their pacemaker that will be made while you are in the intensive care unit recovering from your left ventricular assist device (LVAD) surgery. Participants will undergo these adjustments while still intubated (with a breathing tube left in after surgery) and sedated (in a medically-induced sleep) and the specific changes will involve increasing the rate that the pacemaker paces at and the leads (wires) that the pacemaker utilizes if more than one combination is available. While the pacemaker is set to pace at different, increasing heart rates, pressures will be measured in the different chambers of the heart utilizing a special type of intravenous (IV) line called a pulmonary artery catheter that will have been in place following the surgery. Several small blood samples will also be drawn from this venous catheter in order to measure oxygen levels in the blood. It will take approximately 30 minutes to perform the study, and when it is completed, the pacemaker will be returned to its original settings.

Institution
MUSC
Recruitment Contact
Daniel Silverman
6308023360
dns200@musc.edu

Training in Exercise Activities and Motion for Growth (TEAM 4 Growth): A Randomized Clinical Trial

Date Added
December 7th, 2020
PRO Number
Pro00084526
Researcher
Frances Woodard

List of Studies


Keywords
Cardiovascular, Children's Health, Heart
Summary

This is a Phase III randomized controlled trial of a passive ROM exercise program that will be performed in infants with HLHS and other single right ventricle anomalies following the Norwood procedure at PHN and Auxiliary Centers.

Institution
MUSC
Recruitment Contact
Mary Freeman
8437925762
freemanme@musc.edu

SyncAV Post-Market Trial Clinical Plan

Date Added
November 24th, 2020
PRO Number
Pro00104639
Researcher
Michael Gold

List of Studies


Keywords
Heart
Summary

The purpose of this research study is to evaluate a different way 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 note that they feel better. The objective of the device programming required by the study is to see if it reduces the size of the heart and make the heart pump more effectively.

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

ALgorithm using LINQ Sensors for EValuatIon And TreatmEnt of Heart Failure (ALLEVIATE-HF)

Date Added
September 22nd, 2020
PRO Number
Pro00103625
Researcher
Michael Field

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure
Summary

This study involves individuals who have been diagnosed with heart failure, a condition where the heart does not pump blood as well as it should. For this study, a new software program called ALLEVIATE-HF will be studied to see if the software program can help predict worsening heart failure symptoms. The software program will be put onto a medical device called the Reveal LINQ Insertable Cardiac Monitoring (ICM) System. Some participants may already have the Reveal LINQ ICM. If a participant does not already have a Reveal LINQ ICM, then the device will be inserted under the skin. The ALLEVIATE-HF software will help the device identify problems related to heart failure. The device will collect data such as the subjects heart rate and activity level. The information gathered by this system will help the study doctor/healthcare provider and the study team understand an individual subject's risk of having a heart failure event (worsening heart failure symptoms requiring additional treatment or hospitalization) so that steps can be taken to manage their heart failure.

The study will last at least 7 months but may last up to 3 years. There will be at least 2 but up to 4 visits during the study.

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

Molecular links between Alzheimer's Disease and Cardiomyopathy

Date Added
June 16th, 2020
PRO Number
Pro00071077
Researcher
Federica del Monte

List of Studies


Keywords
Alzheimers, Dementia, Genetics, Heart
Summary

Patients with Alzheimer Disease and patients with Heart failure (and a control group free from both the previous mentioned conditions) will be evaluated with cardiac and neuropsychological assessments, in order to investigate the relationship between the two conditions. 8 follow up visits will be repeated yearly, for 8 years.

Institution
MUSC
Recruitment Contact
Gianlorenzo Daniele
843-442-6981
daniele@musc.edu

The Nanowear Wearable Heart Failure Management System Multiple Sensor Algorithm Development and Validation Trial (NanoSense)

Date Added
April 28th, 2020
PRO Number
Pro00098518
Researcher
Adrian Van Bakel

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure
Summary

This study is being done to find out if we can better monitor subjects with heart failure with the use of a wearable device (called SimpleSense garment) that can monitor multiple factors of heart failure that affect the body such as heart rate, activity, heart rhythm, and respiratory rate. Participants will wear the SimpleSense garment for 90 days for at least 12 hours daily. Participation in the study will include two research clinic visits and 2 phone calls over 4 months. Participants will be compensated for time and travel.

Risks of this study include loss of confidentiality, blood draw and skin irritation from wearing the garment.

Institution
MUSC
Recruitment Contact
Jacques Johnson
843-876-5873
johnjacq@musc.edu



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