SURVEILLANCE HEARTCARE® OUTCOMES REGISTRY (SHORE) Save

Date Added
June 19th, 2019
PRO Number
Pro00086580
Researcher
Adrian Van Bakel

List of Studies

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Keywords
Cardiovascular
Summary

The purpose of this registry is to observe outcomes of heart transplant recipients who are managed with HeartCare. This is done by collecting information about the participant's heart transplant such as test results, biopsy results, and outcomes, storing that information in a database, and using that information for research. HeartCare is a combination of two tests from one blood draw. One test, AlloMap®, is a well-established test for heart transplant recipients. The other test, AlloSure-Heart, is a new test that directly measures injury of the transplanted heart. HeartCare provides the results of both tests for a noninvasive assessment at time of testing. The registry will be active for up to 5 years after enrollment.

Institution
MUSC
Recruitment Contact
Anthony Awkar
8438765009
awkar@musc.edu

A Randomized Controlled Trial Comparing Monitored Anesthesia Care versus General Anesthesia with Transesophgeal Echocardiography for Transcatheter Aortic Valve Replacement Save

Date Added
June 18th, 2019
PRO Number
Pro00088473
Researcher
George Whitener

List of Studies


Profiles_link
Keywords
Cardiovascular, Heart, Surgery
Summary

This study is being done to evaluate the impact that monitored anesthetic care (MAC) versus general endotracheal anesthesia (GETA) has on hospital length of stay, rate of ICU admission, or procedural mortality. Also, we hope to determine if the use of Transesophageal Echocardiography (TEE) during GETA impacts device success and durability. Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis may be eligible candidates for this study.

Institution
MUSC
Recruitment Contact
Christine Aanstoos
8437921869
aanstoos@musc.edu

ECG Belt for CRT Response (ECG Belt) Save

Date Added
May 19th, 2019
PRO Number
Pro00085400
Researcher
Michael Field

List of Studies

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Keywords
Cardiovascular
Summary

The purpose of this study is to compare the management of CRT device patients using the Medtronic ECG Belt Research System and using routine hospital practice. The participant will be assigned (randomized) to one of 3 study groups. The ECG Belt Research System will be used for data collection at Post-Implant follow-up, 6 months, and 9 months for all groups, in addition to the following:

? Group 1 ? About 200 subjects will be in this group. If participant is in Group 1, he/she will have an ECG Belt guided implant procedure. The ECG Belt Research System will be used to help with the programming of device at Post-Implant follow-up and the 6 month visit.
? Group 2 ? About 100 subjects will be in this group. Participant will have a routine implant procedure. The ECG Belt Research System will be used in blinded mode at your post-implant follow-up visit. It will be used to help with the programming of device at the 6 month visit.
? Group 3 ? About 100 subjects will be in this group. Participant will have a routine implant procedure. The ECG Belt Research System will be used in blinded mode at the post-implant follow-up visit and 6-month visit.

The ECG Belt Research System is investigational because it is not approved to be used outside of a study. The experimental procedures in this study are: The ECG Belt guided implant procedure and optimizing CRT settings using the ECG Belt Research System.

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

Pulmonary Hemodynamics during Exercise - Research Network Save

Date Added
May 16th, 2019
PRO Number
Pro00087395
Researcher
Ryan Tedford

List of Studies

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Keywords
Cardiovascular, Heart
Summary

Elevated pressures in the heart can represent a severe medical condition known as pulmonary hypertension. This can result in chronic right heart failure. An abnormal increase in this pressure during exercise may be represent an early stage of vascular lung disease. This study will investigate the prognostic implications of the measured pressures obtained during exercise while undergoing a right heart catheterization procedure based on a large scale multi-center approach by using retrospective and prospective analysis of hemodynamic data.

Institution
MUSC
Recruitment Contact
Brandon Sykes
843-876-5873
sykesb@musc.edu

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of SOtagLiflozin on Clinical Outcomes in HemOdynamIcally STable Patients with Type 2 Diabetes POST Worsening Heart Failure Save

Date Added
May 14th, 2019
PRO Number
Pro00082460
Researcher
Bhavadharini Ramu

List of Studies

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Keywords
Cardiovascular, Diabetes
Summary

Sotagliflozin (SAR439954) is a medicine you take by mouth that is being developed by Sanofi for the potential treatment of type 2 diabetes (T2DM). Sotagliflozin is an "investigational drug". The purpose of the study is to show that sotagliflozin can decrease the risk of cardiovascular death, or decreases the risk of being hospitalized for heart failure. Furthermore, the study will observe whether sotagliflozin reduces the risk of kidney disease, or if sotagliflozin could lead to changes in the way you use other medications. The study will last about 3 years and involve about 4000 participants. The Study has 3 main periods, as follows: Screening, a Double-Blind Treatment period, and a Follow-Up period.

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

A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients with Heart Failure and Preserved Left Ventricular Ejection Fraction (PHHFpEF) Save

Date Added
March 25th, 2019
PRO Number
Pro00085482
Researcher
Ryan Tedford

List of Studies

Silhouette
Keywords
Cardiovascular
Summary

The purpose of this study is to find out if levosimendan is safe and effective in improving symptoms and outcomes for patients with PH-HFpEF.

This study compares an active drug to a placebo. The participant will receive either the active drug, levosimendan, or a placebo via a 24 hour infusion. The study will take place over 6 weeks.

Institution
MUSC
Recruitment Contact
Elizabeth Szwast
843-792-8300
hinsone@musc.edu

An Open-Label Rollover Study of Levosimendan in Patients with Pulmonary Hypertension with Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF) Save

Date Added
March 20th, 2019
PRO Number
Pro00086421
Researcher
Ryan Tedford

List of Studies

Silhouette
Keywords
Cardiovascular
Summary

The purpose of this study is to find out if levosimendan is safe and effective in improving symptoms and outcomes for patients with PH-HFpEF who have previously participated in the TNX-LVO-04 study. All patients who are enrolled in this study will receive levosimendan weekly through a 24 hour infusion at their home. Office visits will occur at weeks 3, 6, 12, 24, 48, and final visit.

Institution
MUSC
Recruitment Contact
Elizabeth Szwast
843-792-5935
hinsone@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Cardiomyopathy (ATTRIBUTE-CM Trial) Save

Date Added
March 4th, 2019
PRO Number
Pro00086011
Researcher
Daniel Judge

List of Studies

Silhouette
Keywords
Cardiovascular, Genetics, Heart
Summary

Amyloidosis (ATTR) Cardiomyopathy (CM) is a progressive, fatal disease in which amyloid deposits build up slowly, over the course of many years to cause organ damage. This study is evaluating the safety and tolerability of a new drug called AG10 administered to adult patients with symptomatic transthyretin amyloid cardiomyopathy. The participant will be randomized to the study drug or placebo and take the study drug two times per day for 30 months.

Institution
MUSC
Recruitment Contact
Anita Smalls
(843) 876-5011
smaani@musc.edu

Safety and Effectiveness of TactiCath Contact Force, Sensor Enabled (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation Save

Date Added
February 12th, 2019
PRO Number
Pro00083338
Researcher
Jeffrey Winterfield

List of Studies

Silhouette
Keywords
Cardiovascular, Heart
Summary

The purpose of this research study is to demonstrate that the TactiCath SE catheter is safe and effective for ablating your symptomatic, persistent atrial fibrillation that is not effectively treated with medication. Participation in the study will last about 15 months from the time of the ablation procedure. Participant will be asked to complete follow-up visits at 7-days (phone call visit only), 3-months, 6-months (phone call), 12-months (phone call or in-person), and 15-months Data collected for this study will be submitted for review and approval by the U.S. Food and Drug Administration (FDA).

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

Multicenter Registry of Chronic Total Occlusion Interventions Save

Date Added
January 3rd, 2019
PRO Number
Pro00083139
Researcher
Anbukarasi Maran

List of Studies


Profiles_link
Keywords
Cardiovascular
Summary

Percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is increasingly being performed in patients with advanced coronary artery disease, but there is limited information on the techniques utilized and the procedural outcomes. The study is a purely observational study that will not affect the clinical care of the participating subjects. All patients undergoing CTO PCI at MUSC will be identified and data will be collected on patient characteristics, procedural techniques and clinical outcomes. If the patient returns for follow-up clinical care at MUSC this data will be collected after the visit as well. Anonymized data from each center will be sent to Minneapolis Heart Institute Foundation where they will be combined into a single database and analyzed.

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

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