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Displaying 1 - 20 of 20

The CORCINCH-HF Study: Study of AccuCinch in Patients with Symptomatic Heart Failure with Reduced Ejection Frraction (HFrEF)

Condition: Heart Disease / Heart Failure
Investigator: Gabriel Sayer, MD
Status: Currently Recruiting
This is a prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Repair System in patients with heart failure and reduced ejection fraction (HFrEF).
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Guided Physiologic Stenting

Condition: Heart Disease / Coronary Artery Disease
Investigator: Megha Prasad
Status: Currently Recruiting
The primary objective is to demonstrate that physiologically-guided stenting using the Philips SyncVision iFR co-registration is superior with respect to clinical outcomes compared to PCI guided by angiography alone. Secondary objectives include: To evaluate the cost-effectiveness of physiology guidance with SyncVision compared to a standard of care PCI…
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Study of OPTIMIZER System in Patients with Heart Failure with Reduced Ejection Fraction (HFrEF)

Condition: Heart Disease / Heart Failure
Investigator: Hirad Yarmohammadi, MD, MPH
Status: Currently Recruiting
You may want to join this study because your heart condition may respond to a device-based therapy called cardiac modulation therapy, CCM therapy, called the OPTIMIZER System.
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The PROTECT IV Trial

Condition: Heart Disease / Coronary Artery Disease
Investigator: Michael Collins, MD
Status: Currently Recruiting
This is a Prospective, multicenter, randomized, parallel-controlled, open-label two-arm trial with an adaptive design that will randomize about 1252 subjects at approximately 120 US and international centers. The study is looking to see if a device called the Impella device will improve the way the heart works as well as if health is improved as compared to…
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AMGEN - Lipid Monitoring following Percutaneous Coronary Intervention (PCI)

Condition: Heart Disease / Coronary Artery Disease
Investigator: Ajay Kirtane, MD, SM
Status: Closed
This is a prospective, single-center, single-blind, two-arm, 1:1 randomized clinical trial. Patients who have undergone successful elective PCI will be screened with a lipid profile and eligible patients will be enrolled. Non-eligible patients will be enrolled in a registry. Randomization will be stratified by baseline LDL-C level and current statin therapy…
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ALLEVIATE-HF: Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure

Condition: Heart Disease / Heart Failure
Investigator: Kelly Axsom, MD
Status: Closed
The ALLEVIATE-HF study is a prospective, randomized, multi-site, interventional, investigational device exemption (IDE) study. The purpose of the study is to gain experience with utilization of an integrated device diagnostic-based risk stratification algorithm to guide patient care in subjects with NYHA class II and III heart failure. The study will…
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LUX-Dx TRENDS - Heart Failure Sensors

Condition: Heart Disease / Heart Failure
Investigator: Elaine Wan, MD
Status: Closed
We are doing this study to collect sensor and heart failure (HF) event data that will be used to develop and test new diagnostic (not providing therapy) features for the insertable cardiac monitor (ICM) systems. ICMs are small devices implanted under the skin and are now widely used for the long-term monitoring and detection of abnormal heart rhythms. ICMs…
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The ARIES HeartMate 3 Pump: Study for People with Advanced Heart Failure

Condition: Heart Disease / Heart Failure
Investigator: Nir Uriel, MD, MSc
Status: Closed
The purpose of this research study is to understand if aspirin is needed in patients heart failure implanted with the HeartMate 3. Patients with devices like the HeartMate 3 take two blood thinner medicines, specifically warfarin and aspirin. Patients implanted with devices like the HeartMate 3 experience both clotting and bleeding complications. Data…
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Transcatheter Aortic Valve Replacement plus medical management versus medical management alone in patients with ADvanced heart failure

Condition: Heart Disease / Heart Failure
Investigator: Susheel Kodali, MD
Status: Closed
This study is for patients who require an aortic valve replacement due to severe aortic stenosis.
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Atrial Fibrillation Among Black and Latinx Heart Failure Patients

Condition: Heart Disease / Heart Failure
Investigator: Meghan Reading Turchioe, PhD, MPH, RN
Status: Closed
We are seeking adults with cardiovascular disease who identify as Black/African American or LatinX, and/or their caregivers, as well as community health workers working in primarily Black/African American or LatinX neighborhoods of NYC, to participate in a brief (30-minute) interviews over the phone or Zoom to discuss attitudes and perceptions related to…
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Study of the Doraya Catheter for Patients with Acute Heart Failure

Condition: Heart Disease / Heart Failure
Investigator: Gabriel Sayer, MD
Status: Closed
The purpose of this trial is to evaluate the feasibility of the Doraya Catheter and measure clinical performance and safety endpoints.
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Study of Dynamic Coronary Roadmap Software During Percutaneous Coronary Intervention (DCR4Contrast Clinical Evidence Study)

Condition: Heart Disease / Coronary Artery Disease
Investigator: Ajay Kirtane, MD, SM
Status: Closed
This study is trying to determine if using a Dynamic Coronary Roadmap (which is a software used along with an x-ray imaging system) reduces the total iodine contrast volume per Percutaneous Coronary Intervention (PCI) procedure compared to procedures performed without Dynamic Coronary Roadmap. This X-ray system provides imaging support while directing the…
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Procyrion - The Aortix CRS Pilot Study

Condition: Heart Disease / Heart Failure
Investigator: Justin Fried, MD
Status: Closed
The purpose of this research is to evaluate the safety and performance of an experimental system called the Aortix System. The system is being designed for use in patients hospitalized for a worsening of their heart failure symptoms and who also show signs of strain on their kidneys. The Aortix System includes a pump, which we hope may help the heart and…
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SARANAS

Condition: Heart Disease / Coronary Artery Disease
Investigator: Tamim Nazif, MD
Status: Closed
The Saranas Early Bird Bleed The Saranas study uses a device is called the Early Bird Bleed Monitoring System (EBBMS) and it is intended to provide physicians with an early indication of a potential internal bleeding complication due to vessel injury that may occur during the procedure before any symptoms present.
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ILumien IV

Condition: Heart Disease / Coronary Artery Disease
Investigator: Ajay Kirtane, MD, SM
Status: Closed
This study has been designed to treat patient with coronary artery disease and demonstrate the superiority of the OCT device used to select and guide the stenting procedure when collecting images and flow measures inside the blocked artery.
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The REFLECT Trial

Condition: Heart Disease / Coronary Artery Disease
Investigator: Susheel Kodali, MD
Status: Closed
This is a research study designed to look at the safety and effectiveness of the TriGUARD 3 cerebral embolic protection device in patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of the study is to assess whether the TriGUARD 3 can prevent death, stroke, more subtle signs of brain injury, and/or silent brain injury as measured…
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FUnctional diagnoSIs of corONary Stenosis (FUSION)

Condition: Heart Disease / Coronary Artery Disease
Investigator: Ajay Kirtane, MD, SM
Status: Closed
The purpose of this study is to collect data for evaluating VFR (Virtual Flow Reserve) in comparison with standard FFR (Fractional Flow Reserve) when patients undergo a percutaneous coronary intervention (PCI) to treat blockage or narrowing in the heart artery or arteries.
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A Study of NuPulseCV intravascular ventricular assist balloon system (iVAS) in promoting blood circulation in Heart Failure

Condition: Heart Disease / Heart Failure
Investigator: Koji Takeda, MD, PhD
Status: Closed
The purpose of this study is to evaluate the NuPulseCV intravascular ventricular assist system (iVAS), a device similar to an Intra-aortic Balloon Pump (IABP) that helps circulate blood from the heart throughout the rest of the body. This study aims to: (1) See if the iVAS improves your blood circulation (2) Better understand how the iVAS device could…
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Chronic Total Occlusion Percutaneous Coronary Intervention (CTO-PCI Study)

Condition: Heart Disease / Coronary Artery Disease
Investigator: Dimitrios Karmpaliotis, MD
Status: Closed
A study evaluating the placement of any guidewire beyond complex narrowed arteries that are relatively common in patients undergoing ballon angioplasty (a procedure where a balloon is used to stretch open narrowed arteries). At least one Teleflex guidewire and at least one Turnpike catheter is used. The guidewires and catheters that are being studied are…
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Inherited bleeding disorder in HeartMate 3 LVAD Recipients

Condition: Heart Disease / Heart Failure
Investigator: Yoshifumi Naka, MD
Status: Closed
The purpose of the study is to characterize von Willebrand Factor (VWF) profiles in patients receiving HeartMate 3 (HM3) and compare them to HeartMate II (HMII) Left Ventricular Assist Device (LVAD).
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