Title: A Prospective Randomized Single-Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR 014 PTCA Drug Eluting Balloon in the Treatment of Subjects with De Novo Coronary Lesions in Small Vessels

Brief Title: SELUTION4DeNovo Small Vessel

Brief Summary: Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm, in support of a pre-market approval (PMA) application to the United States (US) FDA. The Study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy, at up to 80 sites in the US, Canada, Brazil, Japan and Europe. A minimum of 50% of the subjects will be enrolled in the US.

Title: Medtronic Safety and Performance Assessment of the Sphere-9TM Catheter and Affera Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT)

Brief Title: Sphere-9 VT

Brief Summary: Sphere-9 VT is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia due to prior myocardial infarction will be enrolled and treated with the Sphere-9 Catheter and Affera Ablation System.

Title: Assessment of the Carillon Mitral Contour System in Treating Heart Failure with Functional Mitral Regurgitation

Brief Title: EMPOWER

Brief Summary: The objective of this prospective, randomized, blinded clinical trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating heart failure with functional regurgitation (FMR).

Title: Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study of the Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave Javelin Coronary IVL Catheter (FORWARD CAD IDE Study)

Brief Title: FORWARD CAD IDE Study

Brief Summary:

Title: Safety and effectiveness of the TactiFlex SE Catheter and Volt Pulsed Field Ablation (PFA) Generator in subjects with paroxysmal atrial fibrillation

Brief Title: FlexPulse

Brief Summary: The objective of this clinical study is to demonstrate that ablation with the TactiFlex SE Ablation catheter, in conjunction with a compatible pulsed field ablation (PFA) and/or radio frequency (RF) generator, is safe and effective for the treatment of symptomatic, recurrent, drug refractory paroxysmal atrial fibrillation (PAF).

Title: Cryoablation for Monomorphic Ventricular Tachycardia IDE Study: EFS and Pivotal

Brief Title: FULCRUM VT

Brief Summary: The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio VT Cryoablation System in the ablation treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT)

Title: Safety and Effectiveness Post-Approval Study of FARAPULSE Pulsed Field Ablation in Paroxysmal Atrial Fibrillation

Brief Title: Advent PAS

Brief Summary: The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study.

Title: ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression

Brief Title: ADVENT LTO Study

Brief Summary: The (ADVENT LTO) is an observational, non-significant risk study to assess the progression of atrial fibrillation in subjects who received ablation treatment with either the FARAPULSE Pulsed Field Ablation System or thermal ablation in the ADVENT Trial.

Title: Cardiac Resynchronization Therapy Using His/Left BundleBranch Pacing vs Biventricular Pacing with a Left VentricularEpicardial Lead in Patients with Heart Failure (HF) with LeftVentricular Ejection Fraction (LVEF) ≤ 50% and with either aWide QRS Complex (> 130 ms) or with/anticipated > 40%Pacing Randomized Clinical Trial

Brief Title: L vs L RCT

Brief Summary: 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.

Title: A Phase III Crossover Study to Evaluate Bolus Versus Continuous Infusion of Lumason in Patients with Sub-Optimal Unenhanced Echocardiography

Brief Title: Lumason bolus vs infusion

Brief Summary: A phase III study designed as a randomized, within-patient comparison of continuous infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for degree of LVO and assessment of LV EBD (co-primary endpoints).

Title: Metabolomic changes after mixed meal tolerance test as novel markers of heart failure with preserved ejection fraction disease severity

Brief Title: Metabolomic changes after MMTT in HFpEF

Brief Summary: In this study, we will look at how treatment with a class of medication called sodium glucose cotransporter 2 (SGLT2) inhibitors effects the bodys metabolic health in patients who have heart failure with preserved ejection fraction. We will test metabolism by giving a person a meal and measure how levels of small molecules change before and after the meal. We will repeat this test again after 12 weeks of treatment with SGLT2 inhibitors and see how the molecules responses to a meal change with drug treatment.

Title: Advancing Cath Lab Results with FFRangio Coronary physiology Assessment: The ALL-RISE Study

Brief Title: ALL-RISE

Title: Cardiometabolic disease and heart failure with preserved ejection fraction

Brief Title: BI HFpEF

Brief Summary: This is a prospective observational study of 250 patients receiving care at BIDMC who have heart failure with preserved ejection fraction (HFpEF). The aim of the study is to better understand the link between cardiometabolic disease and HFpEF. At each visit, we will conduct a physical exam and perform a blood draw, and participants will complete a health questionnaire to assess quality of life. There will be up to 3 study visits over the course of 3 months. About 1 year after enrollment, participants will be re-contacted for a telephone health survey.

Title: Treatment In Thoracic Aortic Aneurysm: Surgery versus Surveillance (TITAN: SvS)

Brief Title: TITAN: SvS

Brief Summary: The ascending aorta conducts blood from the heart to the rest of the body. The ascending aorta can become enlarged, and the risk of tearing and rupturing becomes higher with larger aorta. When the ascending aorta tears or ruptures, the risk dying is high even if surgery is done as soon as possible. Traditionally, when the ascending aorta gets above 5.5 cm, surgery is recommended to replace the aorta. However, this threshold is based relatively weak evidence, and sometimes patients with smaller aorta can tear or rupture. On the other hand, surgery carries its own risk as well. Since there are risk of waiting or doing surgery, there is currently no great support for either approach for patients with a smaller aorta. In the TITAN SvS trial, patients with an ascending aorta between 5.0 to 5.5 cm is assigned by chance to the early surgery group, in which they will undergo replacement of aorta, or the surveillance group, in which they will be closely monitored. The chance of dying or suffer tearing or rupture of aorta between the two groups will be compared. The result of the trial will guide future practice for patients with enlarged ascending aorta. This is a prospective, multi-centre randomized control trial that compares the all-cause mortality, aneurysm-related aortic events, rate of stroke, and quality of life for those patients undergoing early elective ascending aortic surgery to those patients undergoing surveillance. Patients referred for an ascending aortic aneurysm that meets the inclusion criteria will be randomized to the early elective surgery group or the surveillance group. Recruitment will end when the desired sample size is reached, and the patients will be followed for a minimum 2-year period. The primary objective of the trial is to compare the composite outcome of the all-cause mortality and incidence of acute aortic events between surveillance and elective ascending aortic surgery for patients with degenerative or bicuspid valve-related ascending aortic aneurysm after 2 years of follow up. The hypothesis is that the early surgery group will have a significantly lower all-cause mortality and incidence of acute aortic events at 2 years of follow up compare to the surveillance group. The result of this trial will provide evidence based guidance in the appropriate management of ascending aortic aneurysm based on the size criteria, and establish a large database for future investigations.

Title: Transcatheter Mitral Valve Replacement with the Medtronic Intrepid TMVR System in patients with severe symptomatic mitral regurgitation – APOLLO Trial

Brief Title: APOLLO Trial

Brief Summary: Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.

Title: Evolut TM EXPAND TAVR II Pivotal

Brief Title: Evolut TM EXPAND TAVR II Pivotal

Brief Summary: Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.

Title: Physio-Anatomy Clinical Data Collection

Brief Title: Gentuity Study

Brief Summary: This is an on-label clinical study design intended for the collection of three different types of interventional procedural data using FDA-cleared cardiac catheterization technologies and drugs, each used according to its product labeling and standard practice of medicine.

Title: Medtronic The SPYRAL AFFIRM Global Clinical Study of Renal Denervation with the Symplicity Spyral Renal Denervation System in Subjects with Uncontrolled Hypertension (SPYRAL AFFIRM)

Brief Title: SPYRAL AFFIRM

Brief Summary: The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation. Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies.

Title: Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI (REFINE PCI)

Brief Title: Physiological Assessment for Optimizing PCI

Brief Summary: Traditionally, the severity of a blockage (stenosis) in a coronary artery has been determined by visual angiographic assessment of the diameter of the artery at the level of a blockage compared to a normal healthy area of the same artery. With the advent of invasive physiological testing to assess coronary blood flow, multiple clinical trials have demonstrated a clinical benefit to a physiology-guided percutaneous coronary intervention (PCI) approach. However, despite this and the potential for significant variation in the interpretation of coronary artery stenosis severity by visual angiography alone to guide PCI, invasive physiologic indices remain significantly under-utilized. The purpose of this study is to investigate the physiologic significance of coronary lesions deemed angiographically severe by visual estimation that are planned for PCI. The investigators plan to perform blinded physiologic assessment pre and post PCI. The primary aim of the study is to determine whether a subset of lesions visually estimated as severe by angiography treated with stent placement/PCI may in fact not be physiologically significant when assessed invasively, and thus PCI could safely be deferred in these patients. A secondary aim is to evaluate physiologic assessment post PCI to detect residual ischemia that could be utilized to optimize stent placement.

Title: Long-Term Endothelial Effects of COVID-19 in Obesity

Brief Title: Long-Term Endothelial Effects of COVID-19 in Obesity

Brief Summary: The CLEO study examines the long-term effects of COVID-19 infection and whether these effects are different in people who have obesity compared to people who do not have obesity. Participation in the study will involve a physical exam, IV placement with blood sampling, cell collection from a vein, ultrasound, and cardiac PET adn will take approximate 1 to 4 study visits over 1 to 6 months at BIDMC and Brigham and Womens Hospital BWH).

Title: Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature

Brief Title: Elegance

Brief Summary: The ELEGANCE Registry's objective is to collect Real-World Data (RWD), including populations previously not represented in Peripheral Vascular Disease (PVD) trials, health economics data, and to support the safe use of commercially available Boston Scientific Corporation (BSC) drug-eluting devices for the treatment of lesions located in the peripheral vasculature.

Title: Clinical trial of atrial fibrillation patients comparing left atrial appendage occlusion therapy to non-vitamin K antagonist oral anticoagulants

Brief Title: Clinical trial of atrial fibrillation patients comparing lef

Brief Summary: The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion.

Title: Randomized Clinical Evaluation of the AccuCinch Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)

Brief Title: The CORCINCH-HF Study

Brief Summary: Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).

Title: Edwards PASCAL TrAnScatheter Mitral Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A prospective, multicenter, randomized controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with mitral regurgitation

Brief Title: Edwards PASCAL CLASP IID Pivotal Clinical Trial

Brief Summary: To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)

Title: Patient reported outcomes assessment in coronary and peripheral artery diseases

Brief Title: Patient reported outcomes in coronary and peripheral

Brief Summary: The Patient Reported Outcomes Assessment in Coronary and Peripheral Artery Diseases study (referred to as PAD PROMs in short) is a longitudinal study that assesses patient outcomes with treatment following peripheral artery disease (PAD) diagnosis. The study involves a baseline survey and surveys taken 1 month, 6 months, and 1 year after intervention and will ask questions relating to the participants symptoms in relation to their peripheral artery disease.