Search Results
Global SYMPLICITY Registry (GSR) Denervation Findings in Real World (DEFINE)- US Cohort is referred to as the GSR DEFINE- US Cohort study
A PROSPECTIVE, OBSERVATIONAL STUDY THAT WILL DOCUMENT THE LONG-TERM SAFETY, EFFECTIVENESS, AND DURABILITY OF RENAL DENERVATION IN A REAL-WORLD POPULATION, AGED 65 YEARS OR GREATER WITH HYPERTENSION IN THE UNITED STATES.
Sarah Ackroyd - sackroy1@hfhs.org
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
TRITON-CM: A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nucresiran in Patients with Transthyretin-Mediated Amyloidosis with Cardiomyopathy (ATTR amyloidosis with cardiomyopathy)
The purpose of this research study is to test whether nucresiran is safe and helps people with transthyretin amyloidosis (ATTR) with cardiomyopathy. In this study, the effects of nucresiran are compared to the effects of placebo. At the beginning of this study, each person will have a 2 out of 3 (67%) chance of being placed in the nucresiran group.
Jodi Carter - GeneralCardiologyResearch@hfhs.org
• Adults age 18-85 years old at the time of screening.
• Documented diagnosis of ATTR amyloidosis with cardiomyopathy, classified as either hATTR amyloidosis with cardiomyopathy or wtATTR amyloidosis with cardiomyopathy.
• Patients may be receiving approved TTR stabilizers for ATTR amyloidosis (eg, tafamidis, acoramidis).
• Screening NT-proBNP >300ng/L; in patients with permanent or persistent atrial fibrillation, Screening NT-proBNP >600 ng/L and <8500 ng/L.
• Has known primary amyloidosis (AL amyloidosis) or leptomengeal amyloidosis
• Has a polyneuropathy disability requiring a cane or stick to walk or is wheelchair bound
• Received prior or currently receiving TTR-lowering therapy (eg, revusiran, patisiran, inotersen, eplontersen, or vutrisiran or gene therapy targeting TTR)
• Prior or anticipated (during the first 12 months after randomization) heart, liver, or other organ transplant or implantation of LVAD
• Has untreated hypo- or hyperthyroidism
• Had acute coronary syndrom or unstable angina within the past 3 months
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
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Assess Efficacy and Safety of Omecamtiv Mecarbil in Patients with Symptomatic Heart Failure with Severely Reduced Ejection Fraction (COMET-HF)
A new study called COMET-HF (sponsored by Cytokinetics, Inc.) is looking to see whether a study medicine called omecamtiv mecarbil can lower the risk for heart failure-related events and deaths, heart transplant, and strokes in people who have heart failure with a low ejection fraction (when the heart isn?t pumping out as much blood as it should with each beat).
Zack Malouf - Zmalouf1@hfhs.org
The Radial vs. State-Of-The-Art FEmoral Access for Bleeding and Access SIte Complication Reduction in Cardiac CaTHeterization (REBIRTH) Trial
The primary study objective is to evaluate whether radial access for cardiac catheterization of patients reduces vascular access complications and bleeding occurring within 72 h of the procedure or by hospital discharge, when compared with state-of-the-art femoral access. Patients randomized to femoral access will be further randomized to use of a micropuncture (21 gauge) vs. standard (18 gauge) needle.
Michelle Butcher - mbutche1@hfhs.org
• Age greater than 18 years
• Patients undergoing cardiac catheterization
• Has provided informed consent and agrees to participate
• Patients must be equally eligible to undergo cardiac catheterization via radial or femoral access
• Patients arriving for emergency heart attack
• Patients undergoing only planned right heart catheterization, with no plan for concurrent left heart catheterization
• Valvular heart disease requiring valve surgery within 30 days after the index procedure
• Hemodialysis access (arteriovenous fistula or graft) in the arm to be used for PCI in case of assignment to radial approach (the opposite arm may be used for radial access if a dialysis graft is present in one)
• Peripheral arterial disease prohibiting vascular access
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.
HEART Camp Connect - R01
This study aims to promote long-term adherence to exercise in adults with heart failure with preserved ejection fraction (HFpEF) by providing an exercise coach for up to one year. We will test a virtual group and in-person group against each other and against virtual enhanced usual care.
Crystal Grimshaw - cgrimsh1@hfhs.org
• diagnosis heart failure with EF >50%
• age >19 years old
• Echocardiogram within past 24 months
• chest pain
• heart attack, coronary artery bypass surgery, or pacemaker implant within past 6 weeks
• ICD (defibrillator)
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
ACHIEVE GREATER: Addressing Cardiometabolic Health Inequities by Early PreVEntion in the GREAT LakEs Region
ACHIEVE-P4: PATHFINDER is a study looking at the impact on symptoms and outcomes of heart failure patients utilizing portable air cleaners in their home. Participants will receive two portable air cleaners and an indoor air quality sensor. The air cleaners will be randomized to either have filters in them or not. Follow-up in-person visits are scheduled at 30- and 90-days after enrollment.
Whitney Cabral - WCABRAL1@hfhs.org
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.
A Randomized Comparison of Cleerly Coronary Artery Disease Stage-Based Care Versus Risk Factor-Based Care for Primary Prevention of Cardiovascular Events (TRANSFORM)
This research study is testing whether using heart artery imaging and personalized treatment plans can better prevent heart attacks and other heart-related problems in people at higher risk for heart disease, even if they do not have symptoms. The study includes adults with diabetes, prediabetes, or metabolic syndrome and compares this approach to standard care based only on traditional risk factors.
Jodi Carter - GeneralCardiologyResearch@hfhs.org
• Men over the age of 55, women over the age of 65
• Must have type 2 diabetes, prediabetes, or metabolic syndrome
• History of established cardiovascular disease
• Decreased kidney function
• Allergy to contrast
• LDL of <70 mg/dL
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
Using polygenic scores to guide betablocker therapy for heart failure with mildly reduced ejection fraction (UPBEAT).
Heart failure (HF) is a major public health problem that displays wide variation in progression and response to therapy. UPBEAT is a clinical trial pilot study that will use polygenic scores, a tool which describes differences in genetics, to examine effectiveness of beta blocker medication, a cornerstone of heart failure therapy. Participation requires 8 in-person visits, and randomized assignment to beta-blocker versus placebo medication.
Whitney Cabral - wcabral1@hfhs.org
The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction with VISITAG SURPOINT Module for the treatment of symptomatic drug refractory paroxysmal atrial fibrillation (A nested sub-study of REAL AF registry)
The purpose of this research is to provide additional information about safety and effectiveness of the VISITAG SURPOINT Module with external processing unit (EPU) when used with QDOT Micro? System.
Briita Wanhala - bwanhal1@hfhs.org
• 18 years of age or older
• Symptomatic atrial fibrillation refractory to antiarrhythmic drugs (AADs)
• Scheduled or have undergone an atrial fibrillation ablation usint the QDOT Micro? System
• Patients who have undergone catheter ablation for atrial fibrillation (PVI, roof line, posterior wall ablation...)
• Persistent or long-standing persistent atrial fibrillation
AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidANCE in PCI for De Novo Coronary Artery Disease
The AGENT DCB STANCE study will compare the AGENT Paclitaxel Coated Balloon Catheter to standard of care treatment with drug-eluting stents and/or balloon medical procedure to open blocked or narrowed blood vessels.
Melanee Schimmel, BSN, RN - mschimm2@hfhs.org
• Must be at least 18 yrs of age
• Understands and the willingness to comply with all study required follow-up evaluation
• Women of child-bearing potential must agree to use a reliable method of contraception for 1 year.
• Other serious medical illness that may reduce life expectancy to less than 1 year.
• Serious problem with substances (alcohol, cocaine, heroin, etc.)
• Currently participating in another experimental drug/device study that has not met the outcome the study is measuring
• Is pregnant and nursing
• Has had a non-surgical procedure used to open narrowed or blocked coronary arteries with a balloon or stent
• Been diagnosed with severe heart failure within the past 6 months
• Known allergy to paclitaxel or other parts of the medical devices that are used.
• Severe renal failure
A phase III, double-blind, randomized placebo-controlled study to evaluate the effects of dalcetrapib on cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary Syndrome (ACS): The DAL-302 (dal-GenE-2) trial
This research study is testing whether a medication called dalcetrapib can help lower the risk of future heart attacks in people who were recently hospitalized for acute coronary syndrome and have a certain genetic profile. The study compares dalcetrapib to a placebo to see if personalized, genetics-based treatment can better prevent serious heart problems.
Jodi Carter - GeneralCardiologyResearch@hfhs.org
• Age 45 or older
• Heart Attack within the last 90 days
• Must have AA genotype to move forward in study (we will perform the test for this at day 1
• Severe heart failure
• Severe kidney failure
• Received bypass surgery since the recent heart attack
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
Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure (DRAIN-HF)
This study is testing whether the Aortix System is safe and works better than standard medical treatment for people who are hospitalized with acute heart failure and still have excess fluid buildup (congestion) even after receiving the usual treatments.
Kristin Clark - kclark2@hfhs.org
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 placebo-procedure controlled trial of the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System PULmonary artery denervation Safety and Efficacy in patients with combined pre- and post-capillary pulmonary hypertension associated with Left Heart Disease
A research study providing new treatment for pulmonary hypertension (high blood pressure in the arteries in the lungs) caused by left -sided heart disease. This study will evaluate the safety and effectiveness of investigational device called the Multi-Pole Pulmonary Artery Frequency Ablation Enhancor System ("Enhancor System").
Danielle Holmes - dholmes7@hfhs.org
• Subject is diagnosed with left sided heart failure for at least 6 months prior to being evaluated for the study and remains symptomatic despite an optimal medication regimen as prescribed by their treating physician(s).
• Patient's vital signs and internal heart pressures completed at screening and day of investigational procedure, prior to investigational implant, meet the study's inclusion requirements.
• . Subject is willing to follow all aspects of the research study, including medication compliance, follow--up visits, and testing.
• Subject has a life expectancy of less than 1 year due to non-cardiovascular causes.
• Subject has any severe heart valve disease.
• Subject has had a stroke or mini-stroke within 30 days prior to study enrollment.
• Subject refuses blood products.
• Subject has severe chronic kidney disease or on dialysis
• Subject has severe liver disease
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.
The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation (REACT-AF)
This research is being done to assess whether it is safe and effective to stop oral anticoagulation medications (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF)
Briita Wanhala - bwanhal1@hfhs.org
• 22-85 years of age
• History of non-permanent atrial fibrillation on anti-coagulants
• CHA2DS2-VASC score of 1-4 for men and 2-4 for women without prior stroke or TIA
• Any documented single AF episode lasting ?1 hour on within 45 days prior to randomization
• Existing cardiac rhythm device or indication for a permanent pacemaker, ICD or CRT.
• Participant needs DOAC for reasons other than preventing stroke or arterial embolism resulting from atrial fibrillation.
• Stage 4 or 5 chronic kidney disease
A Phase 3, Randomized, Multicenter, Double-Blind, PlaceboControlled Study of Acoramidis for Transthyretin Amyloidosis Prevention in the Young (ACT-EARLY Trial)
ACT-EARLY is a research study to see if an investigational drug, acoramidis (AG10), is safe and effective in preventing or delaying symptoms of a disease called Transthyretin Amyloidosis (ATTR).This research study will test whether acoramidis treatment in people who do not have the disease but who carry a genetic predisposition to developing the disease is safe and effective in preventing or delaying ATTR disease (genetic predisposition is also referred to as genetic variant).
Kristin Clark - kclark2@hfhs.org
Comparative Effectiveness of Carvedilol versus Metoprolol Succinate in Heart Failure Patients with an Implantable Cardioverter Defibrillator (CARVTOP-ICD)
The purpose of this study is to compare outcomes (such as implantable cardioverter-defibrillator (ICD) treatments, hospitalization or death) in participants with heart failure who are treated with carvedilol versus metoprolol succinate
Briita Wanhala - bwanhal1@hfhs.org
• Patients 18 years of age or older
• Patients with an implantable cardioverter-difibrillator (ICD) implanted for primary prevention for Heart Failure with reduced ejection fraction with remote transmission capability
• Patients currently on treatment with metoprolol succinate and willing to switch to carvedilol
• Patients being treated with a beta-blocker (?B) other than metoprolol succinate
• Patients with a known prior intolerance or contraindication to carvedilol
• Patients with a systolic blood pressure <100 mmHg