A randomized, sham-controLled, clinical Trial For evaLuation Of the EdWards APTURE transcatheter shunt system (ALT-FLOW II)

Date Added
November 28th, 2023
PRO Number
Pro00132875
Researcher
Brian Houston

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure
Summary

This is a study to evalaute the device's safety, function, and effects on heart function, and clinical outcomes of using the Edwards APTURE system (study device) in subjects with heart failure.

Major study activities include 3 right heart catheterizations (RHC) with exercise, a computed tomography (CT) scan with contrast, multiple ultrasounds of the heart, labs, and other assessments. The length of subject participation in the study is 5 years and includes 11 research visits.

The information obtained from this study will show how safe and effective this approach is in treating the symptoms of heart failure. Alternative treatment for heart failure depends on the cause, but may include diet and exercise, managing stress, medication (such as medications to treat leg swelling, high blood pressure, or abnormal heart rate), participation in another research study or continuing with current medical therapy

Institution
MUSC
Recruitment Contact
Shaquanda Ross-Simmons
843-876-5783
shr37@musc.edu

Baroreflex Activation Therapy in left Ventricular Assist Device patients study

Date Added
January 31st, 2023
PRO Number
Pro00115552
Researcher
Brian Houston

List of Studies


Keywords
Cardiovascular, Heart
Summary

This study will examine whether a baroreflex activation therapy device (a small pacemakers that are helpful in heart failure) is beneficial for left ventricular assist device (LVAD) patients. For patients who have a baroreflex activation therapy device and LVAD, we assess whether baroreflex activation therapy helps them feel better and have fewer symptoms. We will also look at whether it helps with recovery of their weak heart. Participation in this study will last 6 months and require 3 clinic visits. At each visit, a participant's symptoms will be assessed, they will have pictures of their heart taken to determine function, and bloodwork will be drawn.

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

Cardiac biopsies in pulmonary hypertension

Date Added
August 21st, 2018
PRO Number
Pro00077070
Researcher
Brian Houston

List of Studies


Keywords
Pulmonary Hypertension, Scleroderma
Summary

Patients with systemic sclerosis (SSc) related pulmonary arterial hypertension (SScPAH) have a worse prognosis than those with idiopathic PAH. We have recently discovered that heart cells in SScPAH do not contract or squeeze as well as in other forms of pulmonary hypertension. However, the mechanism leading to this dysfunction is not understood. To better study this and in hopes of developing a future therapy, we plan to collect tissue samples via a heart biopsy at the time of a clinically indicated heart catheterization.

Institution
MUSC
Recruitment Contact
Brandon Sykes
843-792-1105
sykesb@musc.edu



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