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Displaying 1 - 22 of 22

ACURATE IDE: Study of Acurate Valve for Transcatheter Aortic Valve Replacement

Condition: Valve Disease / Aortic Valve Disease
Investigator: Tamim Nazif, MD
Status: Currently Recruiting
This prospective, multicenter trial is looking at the investigative device called the ACURATE Transcatheter Aortic Valve System for TAVR to see if it is safe and effective in treating patients with severe symptomatic native aortic stenosis. The ACURATE Transcatheter Aortic Valve System for TAVR is designed for iliofemoral access and de…
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The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves). (MITRAL-II)

Condition: Valve Disease / Mitral Valve Disease
Investigator: Isaac George, MD
Status: Currently Recruiting
This is a prospective multicenter study whose purpose is to establish the safety and effectiveness of the Edwards SAPIEN 3 and SAPIEN 3 Ultra valves with Commander delivery system in patients with severe symptomatic calcific mitral valve disease with severe mitral annular calcification (which is…
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Study for subjects with Chronic HCV with advanced liver disease using study drug combination (Sofosbuvir/Ledipasvir + Ribavirn)

Condition: Liver Disease / Hepatitis
Investigator: Robert Brown, MD, MPH
Status: Closed
The purpose of this study is to see if study drug Sofosbuvir/Ledipasvir fixed-dose combination + Ribavirin (SOF/LDV FDC + RBV) are effective in treating people infected with the hepatitis C virus with genotypes 1 and 4, who have advanced liver disease with permanent liver…
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Comparison of a device that delivers sonic energy (sound) versus standard balloon to disrupt hard, calcified vascular blockages

Condition: Heart Disease / Peripheral Arterial Disease
Investigator: Sahil Parikh, MD
Status: Closed
This study is for patients who suffer from a condition where one of the blood vessels that deliver blood to your leg has a significant narrowing. This is called peripheral artery disease (PAD). The narrowing may be suitable for a treatment technique called balloon angioplasty. One of the…
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TAP-DANCE: Temsirolimus Alone or Paired with Dexamethasone After Femoropopliteal Revascularization (Femoral Artery Disease Procedure)

Condition: Heart Disease / Peripheral Arterial Disease
Investigator: Sahil Parikh, MD
Status: Closed
This study is to test if a combination drug/device therapy using TEMSIROLIMUS (Temsirolimus Injection), with or without the generic steroid DEXAMETHASONE (Dexamethasone Sodium Phosphate Injection), can be delivered safely into the tissue around the blood vessel wall at the time of an angioplasty ( which is a a procedure to…
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A study of the SAPIEN 3 Transcatheter Heart Valve and Commander delivery system for patients with Pulmonic Valve Dysfunction

Condition: Heart Disease / Valve Disease
Investigator: Robert Sommer, MD
Status: Closed
This study has been designed to treat patients with a pulmonary conduit or valve that has a large amount of regurgitation or is too narrow and needs to be replaced.
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Portico NG Approval Study in Patients with Symptomatic Severe Aortic Stenosis

Condition: Valve Disease / Aortic Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
Aortic stenosis (AS) or narrowing of the arteries remains one of the most common valvular diseases in the Western population requiring intervention. The deterioration of the aortic valve is more common in the older population and usually along with coronary artery disease (CAD) requires the need…
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A study for patients with chronic hepatitis C and advanced heart failure or lung disease using study drug Harvoni

Condition: Liver Disease / Hepatitis
Investigator: Elizabeth Verna, MD
Status: Closed
This research trial is being conducted to determine the safety and efficacy of HARVONI (an FDA-approved Hepatitis C Virus medication) in HCV (genotype 1, 4, 5, an 6) infected patients who also have advanced heart failure or chronic lung disease. HARVONI has not been tested in patients with HCV and heart failure or chronic…
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Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD) using trial drugs

Condition: Liver Disease / Hepatitis
Investigator: Elizabeth Verna, MD
Status: Closed
The purpose of this study is to determine how safe and effective using three medications (pegylated-interferon, ribavirin and boceprevir) are in curing HCV in patients with end stage kidney disease on hemodialysis. Participants will be prescribed these three medications and will be followed closely through treatment, then for…
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Study to Collect Information on SAPIEN 3 Ultra Transcatheter Heart Valve

Condition: Heart Disease / Valve Disease
Investigator: Tamim Nazif, MD
Status: Closed
This is a prospective, single-arm, observational, multicenter registry. The intent is to gather information on the commercially approved device, device SAPIEN 3 Ultra transcatheter heart valve (THV). This valve consists of a short metal tube (stent) that holds the valve in its intended position and has valve leaflets made of biological material derived from…
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Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV (Liver)

Condition: Liver Disease / Hepatitis
Investigator: Jennifer Elliott, PhD
Status: Closed
NOTE: YOU MUST HAVE HIV AND HAVE EVER HAD HEPATITIS C TO BE ELIGIBLE FOR THIS STUDY!! ............... For individuals who have both HIV and Hepatitis C virus (HCV), heavy drinking poses serious risks to their health. We do not yet know which interventions are effective at helping individuals with HIV and HCV drink less. The goal of the study is to compare…
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A study for patients who require aortic valve replacement using an investigational device called Edwards Intuity Valve System

Condition: Heart Disease
Investigator: Michael Borger, MD
Status: Closed
The purpose of this clinical investigation is to collect human clinical data in order to demonstrate thatthe EDWARDS INTUITY Valve System, EDWARDS INTUITY Aortic Valve, Model 8300ACA/ACD issafe and works properly as an aortic valve replacement and that the EDWARDS INTUITY ValveSystem, EDWARDS INTUITY Delivery System, Model…
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Cross-Seal: Study of the Cross-Seal Suture Mediated Vascular Closure Device System

Condition: Heart Disease / Valve Disease
Investigator: Tamim Nazif, MD
Status: Closed
Are you scheduled for an interventional vascular procedure (e.g. BAV, TAVR/TAVI, EVAR or TEVAR) inorder to replace a damaged or failing valve? This research style studies the safety and efficacy of an Investigational Device (IDE) called the Cross-Seal Suture-Mediated Vascular Closure Device System. This device has not yet been approved by the FDA for use on…
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A study for patients who have a leakage of blood within the tricuspid valve located on the right side of the heart

Condition: Heart Disease
Investigator: Rebecca Hahn, MD
Status: Closed
This study is for patients who suffer from a leakage of blood within on of the valves of the heart. The leakage of blood is also called regurgitation. The valve that is leaking is called the tricuspid valve and it is located within the right side of the heart. This condition is referred to as functional tricuspid regurgitation (FTR). The treatment of FTR…
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ASD Closure - For Patients with Atrial Septal Defects

Condition: Heart Disease
Investigator: Robert Sommer, MD
Status: Closed
The ASD study has been designed to treat patients with an atrial septal defect with the use of the cardioform ASD occluder delivery system. The study will evaluate how safe the cardioform device is and how effective it is when treating patients with an atrial septal defect.
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A study for patients with Chronic Genotype 3 HCV Infection and Cirrhosis using study drugs Sofosbuvir, Velpatasvir and GS-9857

Condition: Liver Disease / Hepatitis
Investigator: Elizabeth Verna, MD
Status: Closed
This study will compare two experimental drugs, named Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination (SOF/VEL/GS-9857 FDC) and Sofosbuvir/Velpatasvir (SOF/VEL) FDC for the treatment ofchronic genotype 3 hepatitis C virus (HCV) infection in patients who have cirrhosis, or scarring of the liver. The purpose of this study…
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An Observational Study of Patients Undergoing Therapy for Chronic Hepatitis B (HBV) Infection

Condition: Liver Disease / Hepatitis
Investigator: Elizabeth Verna, MD
Status: Closed
The TARGET-HBV study engages an observational research design to conduct a comprehensive review of therapeutic outcomes for patients with chronic hepatitis B (HBV) who are currently taking tenofovir alafenamide (TAF) relative to those patients following other treatment regimens. The study will address important clinical questions regarding the management of…
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THE PRIORITIZE STUDY: Study of Oral Regimens for Hepatitis C

Condition: Liver Disease / Hepatitis
Investigator: Elizabeth Verna, MD
Status: Closed
This study will compare the effectiveness of three different FDA approved medicines for Hepatitis C Genotype 1 patients: HARVONI , Viekira Pak and Zepatier and will observe subject experiences before, during, and after HCV treatment. Subjects will be asked to respond to several survey questionnaires and if they would allow their leftover blood collected for…
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An open-label study of trial drug (Peg-IFN & RBV) for pediatric subjects infected with Hepatitis C virus

Condition: Liver Disease / Hepatitis
Investigator: Steven Lobritto, MD
Status: Closed
The purpose of this study is to learn more about the effects of the combination of telaprevir peginterferon alfa2b (Peg-IFN) and ribavirin (RBV) in children with chronic hepatitis C. Investigators will look at how these study drugs may affect childrens bodies and how children break down and eliminate telaprevir. Participants of this study will receive Peg-…
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A study for patients with Chronic HCV Infection using study drugs Sofosbuvir, Velpatasvir and GS-9857

Condition: Liver Disease / Hepatitis
Investigator: Elizabeth Verna, MD
Status: Closed
The purpose of this study is to evaluate the efficacy, safety, and tolerability of SOF/VEL/GS- 9857 FDC in patients infected with Hepatitis C (HCV), and previously treated unsuccessfully. Information about any side effects that may occur will also be collected.
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A study for patients with Chronic HCV Infection using study drug combination Sofosbuvir/Velpatasvir/GS-9857

Condition: Liver Disease / Hepatitis
Investigator: Elizabeth Verna, MD
Status: Closed
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of study drugs Sofosbuvir, Velpatasvir and GS-9857 in comparison to Sofosbuvir and Velpatasvir in patients infected with HCV. Information about any side effects that may occur will also be collected.
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A study for patients with Chronic HCV Infection who have not received an NS5A Inhibitor using study drugs Sofosbuvir/Velpatasvir/GS-9857

Condition: Liver Disease / Hepatitis
Investigator: Elizabeth Verna, MD
Status: Closed
This study will compare two experimental drugs, named Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination (SOF/VEL/GS-9857 FDC) and Sofosbuvir/Velpatasvir (SOF/VEL FDC) for 12 weeks for the treatment of chronic hepatitis C virus (HCV) infection in subjects who have previously been unsuccessfully treated for chronic HCV.. An experimental drug is one that…
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