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CARDIO: Heart Failure - PROACTIVE-HF TRIAL
Dr. Jason Gluck is participating in this trial collecting information which will provide clinicians with a better understanding of the Cordella PA Sensor System as a potential solution for proactive Heart Failure management, early detection of fluid overload and possibly the prevention of worsening Heart Failure symptoms.
CARDIO: Electrophysiology - VANISH-2
Under the direction of Eric Crespo, MD and the Electrophysiology Department, this study will determine whether catheter ablation or antiarrhythmic drug therapy provides the most effective control of important clinical outcomes for patients with prior myocardial infarction and sustained monomorphic ventricular tachycardia.
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CARDIO: Electrophysiology - The Arm Aflutter Study
Dr. Aneesh Tolat is the Principal Investigator for this trial evaluating the safety, feasibility, and efficacy of performing typical atrial flutter ablation through the arm.
CARDIO: Structural - APOLLO
Dr. Talhat Azemi in conjunction with the Structural Heart Team are participating in this international trial evaluating the safety and efficacy of the Medtronic Intrepid TMVR system in patients with moderate to severe or severe symptomatic mitral regurgitation who are unable to have standard transcatheter or surgical repair.
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CARDIO: Vascular - SSB 11-02
The primary objective of the study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis (TBE device) is safe and effective in treating thoracic aortic pathologies.
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CARDIO: Vascular - CREST-2
Dr. Parth Shah and the Vascular Surgery Team will be participating in this two-parallel multi-centered, randomized, observer-blinded endpoint clinical trial. One trial will assess treatment differences between intensive medical management alone compared to carotid endarterectomy with intensive medical management. The parallel trial will assess treatment differences between intensive medical management alone compared to carotid artery stenting plus intensive medical management.
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CARDIO: Vascular - CREST-H
Dr. Shah in conjunction with the Vascular Surgical team will participate in this trial to determine whether patients with cerebral hemodynamic impairment and mild cognitive impairment benefit from carotid revascularization.
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CARDIO: Cardiac Surgery - ON-X Post Approval Clinical Registry Study
Dr. Robert Hagberg and the Cardiac Surgical Team will evaluate the On-X aortic valve performance in normal general open practice using a new lower anticoagulant (blood thinner) dose approved and recommended by the United States Food and Drug Administration (FDA) in 2015.
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CARDIO: Cardiac Surgery - PERIGON
The purpose of this trial is to evaluate the safety and effectiveness of the Medtronic Model 400 aortic valve bioprosthesis in a patient undergoing surgical aortic valve replacement of a native aortic valve, or replacement of a failed prosthesis.
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CARDIO: Cardiac Catheterization - STEMI DTU
This trial hopes to demonstrate that left ventricular unloading with Impella and a 30 minute delay to reperfusion when compared with immediate PCI will show a reduction in infarct size and heart failure related clinical events.
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CARDIO: Cardiac Catheterization - Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa
People who have had a heart attack can have another heart attack and stroke in the future. The test being researched is a blood test that is designed to guide personalized treatment designed to prevent those events.
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CARDIO: Preventive Cardiology - The Horizon Study
The Horizon Study is a randomized double-blind, placebo-controlled, multicenter trial assessing the impact of lipoprotein (a) lowering with pelacarsen (TQJ230) on major cardiovascular events in patients with known cardiovascular disease.
CARDIO: Preventive Cardiology - The CASCADE FH Registry
CAscade SCreening for Awareness and DEtection of Familial Hypercholesterolemia is being conducted under the direction of Dr. Paul Thompson and Preventive Cardiology.
CARDIO: Preventive Cardiology (iSCAD)
The aim of the International SCAD (iSCAD) Registry is to serve as an internationally collaborative, multicenter registry coordinated by an experienced, centralized, coordinating center in an effort to increase the pace of patient recruitment and thereby increase statistical power of studies related to SCAD. This observational iSCAD Registry is being conducted under the direction of Dr. Stephanie Saucier and Preventive Cardiology.
CARDIO: Vascular Surgery C2LOE
Dr. Parth Shah and the Vascular Surgery Team will be participating in the Long-Term Observational Extension of Participants in the CREST-2 (C2LOE) Randomized Clinical Trial study. The purpose of C2LOE is to assess post-procedural efficacy of carotid endarterectomy and carotid stenting.
CARDIO: Heart Failure - Integra-D
The purpose of this study is to evaluate the device effectiveness in converting induced VF at the time of implantation.
CARDIO: Heart Failure - Aim Higher
The purpose of this study is to determine whether CCM® treatment will reduce the occurrence of cardiovascular mortality and heart failure hospitalizations in patients with less severe heart failure.
CARDIO: Ventricular Tachycardia (RADIATE-VT Trial)
The RADIATE-VT trial (NCT 05765175) is the first international, multi-center, randomized controlled trial to evaluate the safety and efficacy of cardiac radioablation (CRA) with Varian's CRA system compared to repeat catheter ablation for patients with high-risk refractory ventricular tachycardia (VT).
CARDIO: Heart Failure - REBIRTH
The objective of REBIRTH is to determine the impact of bromocriptine therapy on myocardial recovery and subsequent clinical outcomes in a placebo controlled double blind randomized trial. There is evidence the earlier the treatment with bromocriptine, the more likely patients are to recover.
CARDIO: Interventional Cardiology - TTVR Early Feasibility Study
This is an early feasibility study to gain early clinical insight into the performance of the Intrepid™ transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self‐expanding bioprosthetic valve within the tricuspid valve.
CARDIO: Cardiac Surgery - Avalus
The purpose of this study is to characterize the safety and effectiveness of the Medtronic Avalus Ultra aortic valve bioprosthesis in patients with aortic valve disease undergoing surgical aortic valve replacement.
CARDIO: Interventional Cardiology - SPIRARE II
Treatment of acute pulmonary embolism.
CARDIO: Interventional Cardiology - SPYRAL AFFIRM
The purpose of this study is to study renal denervation with the Symplicity Spyral Renal Denervation system in patients with hypertension in which lifestyle changes and hypertensive medications cannot control blood pressure.
CARDIO: Vascular Surgery - Performance III
Prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP® Direct System for the treatment of carotid artery stenosis in subjects at elevated risk for carotid endarterectomy (CEA).
CARDIO: Interventional Cardiology - Quadra-PE
The aim of this study is to evaluate the safety and effectiveness of the Akura Thrombectomy System to perform percutaneous mechanical thrombectomy in subjects with clinically significant acute pulmonary embolism.
CARDIO: Cardiac Surgery - IMPROVE-AD
To assess clinical outcomes in patients with subacute (48 hours to 6 weeks) uncomplicated type B aortic dissection undergoing upfront thoracic endovascular aortic repair (TEVAR) + medical therapy vs. a strategy of medical therapy with standard of care surveillance for deterioration.
CARDIO: Interventional Cardiology - PICANTE
This purpose of this trial is to demonstrate 30 day safety and effectiveness outcomes of the KARDION CORY P4 System in subjects who require hemodynamic support during a high-risk PCI procedure.
CARDIO: Structural Heart/Electrophysiology - SIMPLAAFY
The primary objective is to demonstrate the safety and effectiveness of two monotherapy regimens versus dual antiplatelet (DAPT) therapy following post-implant with the WATCHMAN FLX Pro device in a commercial clinical setting.
CARDIO: Structural Heart - EXPAND
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
CARDIO: Structural Heart - RESTORE
Subjects with symptomatic heart disease due to bioprosthetic valve failure (BVF) affecting TAVs and requiring redo Transcatheter Aortic Valve Replacement (TAVR).
CARDIO: Electrophysiology - Left vs. Left Randomized Clinical Trial
The investigators aim to prospectively test the comparative effectiveness of His or Left bundle branch pacing in relation to patient centered outcomes (quality of life, physical activity, heart failure hospitalization, mortality) and comparative safety in relation to device-related complications and re-interventions (e.g., lead dislodgement, infection) relative to standard of care biventricular pacing in patients with heart failure due to left ventricular systolic dysfunction (LVEF≤50%) and with either a wide QRS (≥130 ms) or with/anticipated >40% pacing who are already receiving current standard heart failure pharmacological therapy.
CARDIO: Electrophysiology - OMNY-AF
The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF), an irregular heart rate that causes abnormal blood flow.
CARDIO: ACCLAIM-Lp(a)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) Who Have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event