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

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

List of Studies


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. Due to the COVID-19 pandemic, study participants may be discharged the same day when necessary. 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

Data Capture of 6-Minute Walk Test Performance by a Wearable Monitoring Device in Patients With Transthyretin Amyloid Cardiomyopathy and Heart Failure.

Date Added
April 16th, 2021
PRO Number
Pro00107809
Researcher
Daniel Judge

List of Studies


Keywords
Cardiovascular
Summary

This study is assessing a wearable monitoring device to be used by the study participants in the ATTRibute-CM (AG10-301) study while they complete the 6 minute hall walk at their in clinic study visits. The results of the hall way data captured by the wearable monitor will be compared to the data captured by the study

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

An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

Date Added
August 24th, 2021
PRO Number
Pro00112813
Researcher
Daniel Steinberg

List of Studies


Keywords
Heart, Surgery
Summary

This study is examining the use, safety and performance of an investigational, meaning not approved for commercial use or sale by the US Food and Drug Administration (FDA) device called Transcatheter Mitral Valve Replacement (TMVR). The TMVR is a device used to treat mitral valve disease in patients with heart failure (weakened heart muscle). The device is placed by a non surgical approach using a delivery catheter (hollow tube) placed in your blood vessel at the top of your leg and directed up to your heart. This five year study will include a screening process to determine you meet eligibility criteria. If you qualify you will then be seen for a baseline visit, undergo the procedure to place the device, day after procedure, at hospital discharge, 1,3,6, 12 months, then yearly for up to 5 years. Study related testing includes physical exams, medication review, 6 minute hall walk test, questionnaires, blood work, CT scans, electrocardiogram or ECG (recording of your heart's electrical activity) and echocardiogram (ultrasound test of your heart).

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



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