Validation of the Palliative Performance Scale to predict survival of older adults admitted to the hospital from the Emergency Department. Save

Date Added
August 4th, 2017
PRO Number
Pro00063739
Researcher
Leigh Vaughan
Keywords
Cancer, Dementia, Heart, Kidney, Liver, Pulmonary, Stroke
Summary

The Palliative Performance Scale has been shown to predict survival among hospice and palliative medicine patients in the outpatient and inpatient clinical settings, where lower PPS scores are directly related to shorter survival. We seek to evaluate if this relationship persists among a racially diverse, older adult population when assessed at the time of admission from the emergency department.

Institution
MUSC
Recruitment Contact
Jonas Te Paske
8432597649
tepaske@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

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

Lymphangiogenesis Factors in Heart Failure States (LYFT-HF study) Save

Date Added
February 21st, 2017
PRO Number
Pro00062457
Researcher
Brian Houston
Keywords
Cardiovascular, Heart
Summary

Heart failure often causes fluid to accumulate in the body, leading to congestion and swelling. However, some people who have had heart failure for a long time seem to have very little congestion or swelling, even when the heart failure is poorly treated. We think that this is because lymphatic vessels are able to grow and remove fluid to prevent congestion. We do not know how lymphatic vessels grow. This study will investigate the blood levels of various proteins to see if we can figure out how the lymph vessels of people with long-standing heart failure might grow.

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

AMPLATZER™ Amulet™ Left Atrial Appendage Occluder Randomized Controlled Trial Save

Date Added
November 22nd, 2016
PRO Number
Pro00060406
Researcher
Frank Cuoco
Keywords
Cardiovascular, Heart
Summary

The purpose of the AMPLATZER Amulet Left Atrial Appendage (LAA) Occluder Trial is to find out if the Amulet device is safe and effective when compared to another LAA closure device made by another medical device company named Boston Scientific. The other device, called the WATCHMAN LAA closure device, is approved for use in the United States and many countries in Europe, Australia, and other nations. It is implanted in some patients with non-valvular atrial fibrillation to reduce the risk of stroke. The WATCHMAN device will be used as the Control device in this study.

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

Monitoring Safety and Recurrence of Paroxysmal Atrial Fibrillation after 1st cryo-balloon ablation with and without antiarrhythmic drug therapy during the 90-day blanking period ? examined with adverse event monitoring and Implantable Loop Recorder Save

Date Added
November 4th, 2016
PRO Number
Pro00055684
Researcher
Sultan Siddique
Keywords
Heart
Summary

There is no evidence regarding the rationale behind the routine short-term use of antiarrhythmic drug (AAD) therapy after cryo-balloon ablation for symptomatic paroxysmal atrial fibrillation (PAF). We seek to better understand whether the routine use of AAD post-cryo-balloon ablation makes any difference in short- or long-term success rate in maintenance of normal sinus rhythm (NSR) for symptomatic PAF patients, monitored with an implantable loop recorder. Additionally, we propose to monitor safety related events during the entire study, while particularly examining events that occur during the 90-day blanking period.

Institution
Palmetto
Recruitment Contact
Michele Neese
803-434-7614
michele.neese@palmettohealth.org

BIOTRONIK, Inc. Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads Save

Date Added
October 25th, 2016
PRO Number
Pro00056102
Researcher
Sultan Siddique
Keywords
Cardiovascular, Heart, Surgery
Summary

The BIOTRONIK QP ExCELs study is a prospective, non-randomized, multi-center clinical investigation is to evaluate the safety and effectiveness of the BIOTRONIK Sentus over-the-wire (OTW) QP left ventricular (LV) lead. Male and female patients 18 years of age or older who have standard Cardiac Resynchronization Therapy Defibrillator (CRT-D) indication may be eligible to participate in this study. This clinical protocol includes a single-arm, multi-center, prospective MultiPole Pacing (MPP) sub-study to demonstrate the MPP feature is effective by converting a percentage of CRT non-responders to responders.

Study Site:
Palmetto Heart
8 Richland Medical Park
Columbia, SC 29203

Study Site Principal Investigator Contact Information:
Sultan Siddique, MD at 803-434-3800

Institution
Palmetto
Recruitment Contact
Sultan Siddique
803-434-3800
ClinicalTrialSurvey@PalmettoHealth.org

Grading Aortic Stenosis: A Comparison of Pre-Cardiopulmonary Bypass Transesophageal Echocardiography (TEE) to Preoperative Transthoracic Echocardiography (TTE) Save

Date Added
October 18th, 2016
PRO Number
Pro00059189
Researcher
George Whitener
Keywords
Heart, Surgery
Summary

This study is being done to evaluate if there is a significant difference in aortic stenosis grading on Transesophageal echo versus Transthoracic echo. Patients having aortic valve repair may be a candidate for this study.

Institution
MUSC
Recruitment Contact
Wanda Jones
843-792-1869
joneswr@musc.edu

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