Search Results Within Category "Heart and Vascular"
Suggestions within category "Heart and Vascular"
Clinical Safety and Performance of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation - VISTA-US
This study assesses the VDyne Transcatheter Tricuspid Valve Replacement System's safety and efficacy in treating severe tricuspid regurgitation. Participants receive the VDyne System, with outcomes measured within 30 days and monitored up to 1 year, including adverse events, changes in valve regurgitation, symptom status, and quality of life.
Sahar Razmjou - srazmjo1@hfhs.org
RESTORE Study (REdo tranScatheter aortic valve replacement for Transcatheter aOrtic valve failuRE)
The purpose of this study is to generate clinical evidence on valve safety and performance in patients treated by redo Transcatheter Aortic Valve Replacement (TAVR).
Veronica Gorden - vgorden1@hfhs.org
• Valve dysfunction solely due to a paravalvular leak (a gap between the artificial heart valve and natural heart tissue)
• Active endocarditis- a serious infection of the heart
• Life expectancy less than one year
• Participation in another research study that may influence the outcome of this study
Atlas Pivotal Trial
This study aims to assess the safety and effectiveness of the AltaValve System in treating patients with mitral regurgitation, a condition where the heart's mitral valve does not close tightly, allowing blood to flow backward in the heart. It focuses on patients who cannot undergo surgery or Transcatheter Edge-to-Edge Repair (TEER).
Darla Washington - dwashi19@hfhs.org
• Has symptoms from heart failure that range from mild limitations during normal activities to severe symptoms even at rest
• Significant leakage of the mitral valve rated as moderate-to-severe or severe
• Is not a good candidate for standard mitral valve procedures
• Significant aortic valve, tricuspid valve, or pulmonic valve disease.
• Severe blockage in one or both of the major neck arteries
• Severe COPD or interstitial lung disease or home oxygen use.
• Severe kidney disease, including kidney failure requiring dialysis
• Active cancer (except cancer that is low grade, maintained or in-remission)
• Very high blood pressure
• Inability to walk at least 100 meters in 6 minutes
• Expected to live less than a year due to another major medical condition.
Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation.
This study is evaluating the PASCAL device, a minimally invasive treatment for severe tricuspid valve leakage (tricuspid regurgitation), in patients who qualify for the procedure. The goal is to provide continued access to this treatment and assess its safety and effectiveness by monitoring participants? health, hospitalizations, survival, and quality of life over time. Participants will be followed for at least 24 months, with long-term follow-up extending up to 5 years.
Sahar Razmjou - srazmjo1@hfhs.org
• Age 18 or older
• Severe or greater tricuspid regurgitation
• New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization within 12 months
• Intermediate or greater surgical risk as determined by Heart Team
• Patient agrees to provide informed consent, follow protocol procedures, and will comply with follow-up visit requirements
• Tricuspid valve anatomy not suitable for device including previous repair or replacement that may interfere with the device
• Significant heart mass, clot, or vegetation
• Severe right ventricle (RV) dysfunction
• Other tricuspid valve disease
• Presence of trans-tricuspid pacemaker or defibrillator leads deemed unsuitable
• Severe existing aortic, mitral, or pulmonic valve disease
JOURNEY: J-Valve to treat aortic regurgitation via transcatheter therapy
The main goal of this study is to see whether a new, less invasive heart?valve device, called the J?Valve Transfemoral System, is safe and works well for people who have severe leaking of the heart?s aortic valve and are considered too high?risk for open?heart valve?replacement surgery.
Sureja Sundaralingam - ssundar4@hfhs.org
• Symptoms that affect daily activities and feeling short of breath or tired with normal activity or even at rest
• Severe aortic valve regurgitation, which means the aortic valve is leaking severe.
• A team of heart specialists has decided the person is too high?risk for open?heart valve surgery.
THE SHIELD STUDY: A PROSPECTIVE, RANDOMIZED, MULTICENTER, SINGLE-BLIND TRIAL TO ASSESS THE SAFETY AND EFFECTIVENESS OF THE ENCOMPASS F2 CEREBRAL PROTECTION SYSTEM VS. STANDARD OF CARE (UNPROTECTED OR SENTINEL? CEREBRAL PROTECTION SYSTEM) DURING TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TF TAVR)
Comparing the safety and effectiveness of the study device, the F2 Cerebral Protection System (accessory used during procedure for brain protection), to our facility's standard of care control group (where no accessory is used) during transfemoral transcatheter aortic valve replacement procedure.
Sara Poggio - spoggio1@hfhs.org
• Age 21-90 years old
• Eligible for transcatheter aortic valve replacement via transfemoral access
• Scheduled for transcatheter aortic valve replacement per physician
Home-based Exercise Program Using Mobile Technology After Left Ventricular Assist Device Implantation (MOVE-LVAD II)
This study is looking at whether a home-based exercise program, supported by mobile technology (such as a smartphone app, wearable device, or remote monitoring tools), can help people who have received a HeartMate 3 (HM3) LVAD become more active, stronger, and healthier after surgery.
Joshua Joven - jjoven2@hfhs.org
Racial and economic disparities and unmet needs in patients with severe aortic valvular disease
This study aims to understand why some people with severe aortic valve disease do not receive treatment and what barriers may prevent them from getting care. Researchers will identify factors that may contribute to missed or delayed treatment and observe how doctors manage this condition in real-world practice.
Darla Washington - dawashi19@hfhs.org
• Disparity or diversity background: racial and ethnic minorities (either race/ethnicity, individuals below the poverty level, non-English speakers, individuals with a 9th grade or lower education
• Patients scheduled for implant or recently implanted with the Edwards Sapien valve
• Diagnosis of severe, symptomatic aortic stenosis and intermediate to high risk for open heart surgery
• Less than 18 years of age.
• Patients who do not allow their records to be used for research.
• Not clinically suitable for transcatheter aortic valve replacement.
Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial (ECHOCATH Trial)
This study investigates the optimization of how blood flows through heart valve replacements after a valve-in-valve transcatheter aortic valve replacement (TAVR) procedure. It compares two methods used to measure valve performance: heart ultrasound and catheter-based pressure measurements. Patients are randomly assigned to have their treatment guided by one of these methods. Researchers will evaluate which approach leads to better valve function, quality of life, and safety outcomes.
Darla Washington - dawashi19@hfhs.org
A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Ataciguat to Slow the Progression of Valvular Dysfunction in Participants with Moderate Calcific Aortic Valve Stenosis
The purpose of this study is to assess how effective the study drug ataciguat could be to slow down the progression of the narrowing of the aortic valve and to see how safe ataciguat is for participants with calcific aortic valve stenosis (CAVS). In this study, some people will take the study drug, ataciguat, while others will be given a placebo.
Jodi Carter - GeneralCardiologyResearch@hfhs.org
• Adults at least 50 years of age at the time of screening
• Moderate CAVS confirmed by Imaging Core Laboratory
• Left Ventricular Ejection Fraction of at least 45%
• Chronic kidney disease Stage 4 or greater
• Prior aortic valve replacement, repair, surgery, or intervention or an anticipated or planned aortic valve replacement in the next 6 months
• Has moderate, moderate-to-severe, or severe mitral stenosis, mitral regurgitation, and/or aortic regurgitation as determined by the Imaging Core Laboratory
• Suspected or known congenital aortic valve disease including bicuspid aortic valve
• Has long-standing persistent or permanent atrial fibrillation
A Study to Assess Safety and Effectiveness of the JenaValve Trilogy Transcatheter Heart Valve System Versus Surgical Valve Replacement in Patients with Aortic Regurgitation
The purpose of this research is the learn if an investigational device, the JenaValve Trilogy Heart Valve System, works just as well as a surgical valve aortic replacement (SAVR) for aortic regurgitation (AR). If you choose to participate in this study, you will be ?randomized? (i.e., randomly selected) into one of two groups: transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR).
Danielle Holmes - dholmes7@hfhs.org
Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Risk Patients who have Severe, Symptomatic, Aortic Stenosis Requiring Aortic Valve Replacement - ENVISION
This study evaluates the safety and effectiveness of the Navitor TAVI system in patients with severe aortic valve narrowing who are at low or moderate surgical risk, aiming to expand its approval. It also includes patients needing valve-in-valve procedures(high surgical risk) for failing artificial valves and those with bicuspid aortic valves to better understand outcomes in these groups.
Sureja Sundaralingam - ssundar4@hfhs.org
• Moderate to severe symptoms from their heart condition that affect daily activities
• Severe narrowing of the aortic valve caused by age-related wear and tear
• Bicuspid Valve Cohort - Aortic valve with two flaps instead of three
• Valve-in-Valve Cohort - high or greater risk for open-heart surgery
Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis (STAR Trial)
To assess the short and long-term safety and effectiveness of the Siegel transcatheter aortic valve replacement (TAVR) device in adults with symptomatic and severe aortic stenosis who are eligible for TAVR. Subjects are randomized to either commercial (FDA approved) or Siegel TAVR device.
Sara Poggio - spoggio1@hfhs.org
• At least 18 years old
• Diagnosed with severe and symptomatic aortic stenosis
• Able to have an aortic valve replacement performed transfemorally (via blood vessels in the leg)
• Heart attack within 30 days
• Stroke/stroke-like event within 6 months
• Gastrointestinal bleed within 3 months
• Significant kidney or liver disease
• Severe lung disease or continuous home oxygen use
A randomized double-blind, placebo-controlled, multicenter trial assessing the impact of lipoprotein(a) lowering with pelacarsen (TQJ230) on the progression of calcific aortic valve stenosis [Lp(a)FRONTIERS CAVS]
This research study is testing whether a medication called pelacarsen can help slow the worsening of calcific aortic valve stenosis (CAVS), a heart valve disease that currently has no proven medication treatment. The study includes people with mild to moderate CAVS and high Lp(a) levels, which may increase disease progression, and compares the medication to a placebo.
Jodi Carter - GeneralCardiologyResearch@hfhs.org
• Age equal or more than 50 and less than 80
• Lp(a) equal or more than 175 nmol/L
• Mild or moderate aortic valve stenosis
• Severe aortic valve stenosis
• Significant additional disease/conditions such as cancer, severe liver or kidney disease, etc.