RADIANCE TRIO Continued Access Protocol (TRIO CAP) A study of the ReCor Medical Paradise System in Clinical Hypertension

Date Added
April 26th, 2022
PRO Number
Pro00118326
Researcher
Thomas Todoran

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure, Men's Health, Women's Health
Summary

The purpose of this study is to see whether a medical device called the Paradise Renal Denervation System (also called The Paradise System) can lower high blood pressure in participants who are known to have hypertension. The device and the treatment delivered by the device, which is known as renal denervation, are investigational in the United States because they haven't been approved by the US Food and Drug Administration (FDA). Renal denervation is a procedure where a catheter is placed inside the blood vessels (renal arteries) that go to the kidneys. Ultrasound energy is created when the catheter is connected to a power source known as a generator. The ultrasound energy will heat up a small area of tissue around the blood vessel to disable nerves that are surrounding the blood vessels. This is a continued access protocol meaning studies have already been done using this device.

This study is for participants who take 3 or more high blood pressure medications but continue to have high blood pressure. This is a five year study consisting of in person visits at screening, baseline, pre procedure testing, procedure and visits at 1,2,3,4,5,6,12,24,36,48 and 60 months. Study related testing includes BP measurements including 24 hour blood pressure readings, electrocardiograms (ECG), blood work, urine studies, and CT scans. Risks associated with this study include procedure risks such as pain, bleeding or bruising at the catheter insertion site. There are other study related risks such as risks of blood draws, radiation risk associated with the CT scan and loss of confidentiality.

Institution
MUSC
Recruitment Contact
Anthony Awkar
843-876-5009
awkar@musc.edu

A Phase 2, Double-blind, Randomized, Placebo controlled Study to Evaluate the Effects of Sotatercept versus Placebo for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF)

Date Added
April 12th, 2022
PRO Number
Pro00119299
Researcher
Daniel Silverman

List of Studies

Keywords
Heart, Pulmonary Hypertension, Shortness of Breath
Summary

The purpose of the study is to evaluate the safety and how well the medication sotatercept works versus placebo in treating Heart Failure with a Preserved Ejection Fraction. The study will also look at information obtained from the tests performed as part of the study to see if subjects have improvement in symptoms of heart failure. Participation in this study will last approximately 26 months. 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, a right heart catheterization with exercise, echocardiogram, and 6 minute hall walks. There will be 35 visits as part of participation in this clinical trial.

Participants will be randomized to either the treatment group (and receive the medication) or the control group (and not receive the medication). Subjects will have a 66:33 chance of receiving the study medication during their participation in the trial. The treatment assignment is determined by randomization, where a computer selects at random which treatment group you will be in (like drawing straws). Neither the subject, nor the blinded personnel will know which group subjects are in. Neither the subject nor the study doctor will decide what group subjects are assigned.

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

A Multi-arm, Multi-Center, Non-Randomized, Prospective, Clinical Study to Evaluate the Safety and Effectiveness of the NEXUSTM Aortic Arch Stent Graft System in Treating Thoracic Aortic Lesions Involving the Aortic Arch: TRIOMPHE

Date Added
February 14th, 2022
PRO Number
Pro00115968
Researcher
Ravi Veeraswamy

List of Studies


Keywords
Heart, Pulmonary Hypertension, Vascular
Summary

The purpose of this research study is to continue to test how well the Endospan NEXUSTM Aortic Arch Stent Graft System performs in the treatment of a diseased aortic arch. The aortic arch is the top part of the main large vessel that carries blood away from the heart. A stent graft is a self-expanding frame that is covered with a material intended to seal the vessel walls.
The NEXUS Aortic Arch Stent Graft System is delivered to the diseased area of your aorta by traveling through your vascular system using fluoroscopic guidance (x-ray pictures), starting with a small incision or needle puncture near your groin (inner thigh). The NEXUS Aortic Arch Stent Graft System is being studied and is not approved by the FDA which means it is investigational in this study. The NEXUS Aortic Arch Stent Graft System has CE Mark which means it is approved for use in Europe. The NEXUS Aortic Arch Stent Graft System is only available through the clinical study in the United States.

Institution
MUSC
Recruitment Contact
Deanna DeHoff
843-792-8522
dehoff@musc.edu

A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Heart Valve System in the Treatment of High Surgical Risk Patients with Symptomatic, Severe Aortic Regurgitation (AR)

Date Added
December 14th, 2021
PRO Number
Pro00116082
Researcher
Nicholas Amoroso

List of Studies


Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System in a patient population with symptomatic severe Aortic regurgitation ( a condition where the heart's aortic valve does not close tightly and allows some blood to leak back into the heart chamber) requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR).

Your involvement in this study will last approximately 5 years from the time of your procedure. The visits include: Screening/Baseline, Procedure, Pre-Discharge, 1 month, 6 months and annualy for 5 years

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

ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve through Implantation of ACURATE in Subjects InDicatEd for TAVR

Date Added
November 23rd, 2021
PRO Number
Pro00114189
Researcher
Daniel Steinberg

List of Studies


Keywords
Heart, Surgery
Summary

This study is enrolling participants with severe aortic stenosis, which is narrowing of one of the heart valves. This condition reduces the amount of blood that can get to the body. This study is collecting data on the safety and effectiveness of an investigational (not yet approved for commercial use by the US FDA (Food and Drug Administration)) device called the ACURATE Aortic Valve System. The procedure to place the device, referred to as TAVR - transcatheter replacement of aortic valve is done in place of open heart surgery. In this study the ACURATE Aortic Valve System will be compared to two commercially available Aortic Valve Systems (valve replacement systems). Participants will be randomized (assigned by choice, like a flip of a coin, in a 1:1 fashion so 50% chance of being assigned to either group like the flip of a coin) to one of two groups. One group will receive the ACURATE Aortic Valve System while the other group will receive one of the commercially available systems. This study will last up to 10 years. Pre-procedure testing is done and reviewed by an eligibility committee to confirm you qualify. Study visits will occur prior to your procedure, during the procedure and throughout your hospital stay, and prior to discharge. Additional visits will occur 1 month and 6 months after your discharge, and then you will either seen or telephoned once per year for the next ten years. Study related testing includes CT scans, physical exams, echocardiograms (ultrasound test of the heart), blood work, and questionnaires.

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

Surveillance and Alert-Based Multiparameter Monitoring to Reduce Worsening Heart Failure Events- SCALE-HF 1

Date Added
November 18th, 2021
PRO Number
Pro00116583
Researcher
Priya Kumar

List of Studies

Keywords
Cardiovascular, Heart
Summary

This study utilizes data from the Bodyport Scale to develop an index that allows for the early detection of worsening heart failure. Participants will receive training on how to use Bodyport Scale and will complete remote follow-up visits. Researchers will look at medical records for heart failure history and any clinical events related to heart failure.

Institution
Self Regional
Recruitment Contact
Erin Wallace
864-943-2416
erin.smith@selfregional.org

Early Feasibility Study of the Edwards SAPIEN 3 System with the Edwards Caval Prestent for the Treatment of Reverse Caval Flow

Date Added
November 9th, 2021
PRO Number
Pro00116089
Researcher
Nicholas Amoroso

List of Studies


Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to evaluate if the Edwards SAPIEN 3 System with Edwards Caval Prestent (study device) can help treat patients with your symptoms (symptomatic heart failure patients with signs of excessive fluid retention) resulting from reverse caval flow (blood flowing backwards instead of forward to your lungs).

The type of research study you are being asked to join is called an Early Feasibility Study. Prior clinical studies have not been conducted for the study device and its safety and effectiveness are unknown. This means the study Device you are receiving has not been previously studied in humans, and that you will be among the first subjects in the world to undergo this treatment. The study device is considered investigational and not approved for commercial sale by the US Food and Drug Administration (FDA). The study device will be placed in the section of your inferior vena cava (IVC) (the major vein that brings oxygen-poor blood from the lower body back to the heart) below your heart and above the veins in your liver via a vein in your thigh.

The clinical benefits of using the study device for treatment of your condition is not well known at this time. Some possible benefits that may occur from use of the study device may include:
relief of symptoms related to heart failure including but limited to, improved fluid retention,
quality of life, and/or improvement in morbidity (illness or disease) and mortality (death).

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

An Open-Label Extension and Safety Monitoring Study of Acoramidis (AG10) in Participants with Symptomatic Transthyretin Amyloid Cardiomyopathy Who Completed the Phase 3 ATTRibute-CM Trial (AG10-301)

Date Added
October 12th, 2021
PRO Number
Pro00114829
Researcher
Daniel Judge

List of Studies


Keywords
Drug Studies, 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 will continue to evaluate the safety and tolerability of a new drug called acoramidis given to adult patients with symptomatic transthyretin amyloid cardiomyopathy. All participants will be given the study medication, which is taken by mouth twice a day.

This study is enrolling subjects who participated in the AG10 301 study, and are eligible to enroll in this study within 30 days of completing the 30 month visit for the AG10 301 study. This study is expected to last approximately 5 years and will have in person visits at day 1, month 1 and then every 6 months along with phone visits quarterly when an in person visit is not required.

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

Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia The RAPID Study (NODE-301 Part 2)

Date Added
September 28th, 2021
PRO Number
Pro00113657
Researcher
John Wharton

List of Studies


Keywords
Drug Studies, Heart
Summary

This study is seeking participants with Paroxysmal Supraventricular Tachycardia (PSVT) which is a specific type of fast heart rhythm, to participate in a randomized study using an investigational (not yet approved for commercial use or sale by the US Food and Drug Administration (FDA) medication versus placebo (looks like medication but there is no active ingredient). The study medication, known as Etripamil, is a nasal spray. Participants will receive a test dose of the medication to see its effect, then be taught to give themselves the medication so the treatment can be done in a home setting. Participants will then be randomized (assigned by chance) to study medication vs placebo to use at home when an episode of PSVT occurs. Participants will also be shown how to place a heart monitor on their chests to record while using the study medication. Participation in this study will last approximately 12-18 months and will include at least 4 clinic visits including screening/test dose visit, randomization treatment, randomization treatment follow up and final study visit. In addition to these 4 visits you will also have a monthly study call or clinic visit to check in with you. Physical exams, vital signs, blood work, urinalysis, ECGs (recording of electrical activity of the heart), placing and using a heart monitor and communicating with a telephone coach are all part of the study procedures.

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

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Comparing the Efficacy and Safety of Tirzepatide versus Placebo in Patients with Heart Failure with Preserved Ejection Fraction and Obesity

Date Added
September 14th, 2021
PRO Number
Pro00111178
Researcher
Sheldon Litwin

List of Studies


Keywords
Heart, Obesity
Summary

The purpose of this research study is to evaluate the safety and effectiveness of tirzepatide compared to placebo (an inactive substance) in the treatment of individuals with Heart Failure with Preserved Ejection Fraction (HFpEF) and obesity.

Participants will undergo a screening visit where they will have a physical exam to asses health and blood will be drawn. If the blood tests show that a participant qualifies to continue, then they will be randomly assigned to either tirzepatide or placebo. Each participant will have a 50:50 chance of being on tirzepatide (like the flip of a coin.) Both tirzepatide and placebo will be supplied as a single dose in an injectable pen device. Subjects will inject the study drug under the skin (or subcutaneous) once a week with the injectable pen. Participation will last at least 52 weeks and may last up to 120 weeks.

Tirzepatide has been proven to provide significant body weight loss and improvement of fat and sugar metabolism in patients with type 2 diabetes. Body weight percent reduction in this study is estimated to be 15% to 16%.

Institution
MUSC
Recruitment Contact
Jacques Johnson
843-792-5873
johnjacq@musc.edu



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