43 results for "Heart (Cardiology)"

ECLIPSE

The purpose of this study is to evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique prior to stent implantation for treatment of severely calcified coronary artery lesions.

CardioMEMS HF System Post Approval Study

The purpose of this Post Approval study is to evaluate the CardioMEMS HF System in patients with Class III Heart Failure in a clinical setting.

Portico™ (Re-sheathable transcatheter Aortic Valve System US IDE Trial)

The PORTICO clinical trial is a prospective, multi-center, randomized, controlled clinical study, designed to evaluate the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and Delivery Systems (Portico) via transfemoral and alternative delivery.

Partner 3

This study is being conducted in order to assess the safety & efficacy of the SAPIEN 3 transcatheter heart valve in low risk patients requiring aortic valve replacement who have severe, calcific, symptomatic aortic stenosis.

MARINER

The purpose of this study is to determine the safety & efficacy of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related death post-hospital discharge in high-risk, medically ill patients.

DREAM HF-1

The primary objective of this study is to determine the efficacy and safety of using Allogeneic Mesenchymal Precursor Cells in chronic heart failure due to left ventricle systolic dysfunction.

Soprano

The purpose of this study is to evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation.

Outcome Allomap Registry (OAR)

The objective of this registry is to observe short and long term clinical outcomes in heart transplant recipients who receive AlloMap testing as part of allograft rejection surveillance.

GENETIC-AF

This study is being done to compare the effects of bucindolol hydrochloride (bucindolol) to metoprolol succinate (Toprol-XL) on the recurrence of symptomatic atrial fibrillation/atrial flutter in patients with heart failure who have a specific genotype for the beta-1 adrenergic receptor.

GRAHF-2 (Genomic Response Analysis of Heart Failure Therapy in African Americans)

The purpose of this study is to evaluate the response to therapy when a fixed dose combination of isosorbide dinitrate and hydralazine (FDC I/H) is enhanced in African Americans with heart failure and reduced ejection fraction (HFrEF) when compared to similar white cohorts.

UNTOUCHED

This is a study that aims to assess the 18 month incidence of inappropriate shocks implanted with the EMBLEM S-ICD system for primary prevention of sudden cardiac death

RAPID (Registry of Angiovac Procedures in Detail Outcomes Database)

The primary objective of this registry is to determine the procedure related mortality associated with the use of the AngioVac device, which is an FDA approved device that is being used in clinical practice for the removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.

MPP PMS (MultiPoint Pacing Post Market Study)

This is a study that aims to understand the use of the MPP technology in real world clinical practice and its impact on the rate of CRT response, programming timing, workflow, rates of heart failure hospitalizations, reduction in heart failure related healthcare utilizations and all –cause mortality.

Medtronic Product Surveillance Registry (PSR)

The purpose of this Registry is to provide continuing evaluation and periodic reporting of safety & effectiveness of Medtronic market-released products.

aMAZE Study

This study is evaluating the safety & effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation.

Barostim Therapy for Heart Failure (BeAT-HF)

The objective of this study is to demonstrate that treatment with the Barostim neo system, relative to medical management, reduces the rate of cardiovascular mortality or worsening heart failure that leads to hospitalization, cardiac assist device or heart transplant.

AdaptResponse Clinical Trial

This study is testing the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices that contain the AdativCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) condition and left bundle branch block (LBBB).

SYNCARDIA 50cc (TAH-T)

The objective of the study is to evaluate whether the 50cc TAH-t can safely support, and provide probably benefit to, transplant-eligible pediatric patients (aged 10-18 years) and adult patients (aged 19-75 years) at imminent risks of death from biventricular failure without experiencing permanent disabling, stroke-related deficits.

Aneurysms and the effects of the CODMAN ENTERPRISE Vascular Reconstruction Device

The CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System is a type of intracranial stent. It is made of a flexible metal material called nitinol and is self-expanding. This device is authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular or fusiform aneurysms arising from a parent vessel with a diameter of ≥2.5 mm and ≤4 mm. Wide-neck is defined as having a neck width ≥4 mm or a dome-to-neck ratio ‹2. The effectiveness of this device for this use has not been demonstrated.

Free Perforations and the effects of the JOSTENT Graft Master

The JOSTENT Graft Master is indicated only for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts ≥ 2.75 mm in diameter.

RADIANCE-HTN (A Study of the ReCor Medical Paradise System in Clinical Hypertension)

This clinical trials is designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in two distinct populations of hypertensive subjects.

WISE LE Study (Evaluation of WIRION™ EPS in Lower Extremities Arteries)

The purpose of this study is to demonstrate the safety & performance of the WIRION™ EPS in subjects undergoing lower extremity atherectomy for the treatment of Peripheral Arterial Disease (PAD)

EARLY TAVR (Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patien

The purpose of this study is to evaluate the TAVR compared to surveillance for patients with asymptomatic severe aortic stenosis.

THAOS

THAOS is a global, multi-center, longitudinal observational survey open to all patients with Transthyretin-associated amyloidosis, including both inherited and wild-type disease and participants with TTR mutations without a diagnosis of ATTR.

Brady MRI PAS (SJM Brady MRI Post Approval Study)

The purpose of this study is to evaluate the long-term safety of the FDA approved St. Jude Medical Tendril MRI lead implanted with a SJM Brady MRI implantable pulse generator in subjects with a standard bradycardia pacing indication.

PARADISE-MI (Prospective ARNI vs ACE Inhibitor Trial to Determine Superiority in Reducing Heart Fail

The purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg twice daily, in addition to conventional post-AMI treatment, in reducing the occurrence of composite endpoint of CV death, HF hospitalization and outpatient HF (time-to-first event analysis) in post-AMI patients with evidence of LV systolic dysfunction and/or pulmonary congestion, with no known prior history of chronic HF.

MOMENTUM 3 (Momentum 3 CAP Continued Access Protocol)

The objective of the study is to continue to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the MOMENTUM 3 IDE Study.

ELITE (Eliminate Thombroembolism: Improving Anticoagulation in Non-valvular Atrial Fibrillation Pati

This study is a 2 year research project to assess warfarin management issues faced by atrial fibrillation patients in ambulatory settings.

Vest Registry

The purpose of VEST trial is to test the hypothesis that a non-invasive wearable cardioverter defibrillator (WCD) will reduce sudden death and death due to ventricular arrhythmia in the first 90 days following an MI in participants with left ventricular dysfunction (EF≤35%).

Leadless II

Nanostim’s safety and effectiveness trial for a leadless cardiac pacemaker.

**This study is not accepting new participants at this time.

Heart Failure and the effects of the OPTIMIZER® System

Evaluation of the Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure With Ejection Fraction Between 25% and 45%: FIX-HF-5C

**This study is not accepting new participants at this time.

Respond CAS

The objective of the Continued Access study is to gather confirmatory evidence on the safety of the SonRtip lead and performance of the automatic atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in the PARADYM RF SONR Cardiac Resynchronization Therapy with Defibrillation (CRT-D) device (Model 9770) in a patient population that is reflective of current heart failure treatment practice.

OPUS Registry

Opsumit is a newly available endothelin receptor antagonist (ERA) in the US. Evaluating the safety profile of Opsumit in the post-marketing setting will provide further characterization of its use from clinical practice. This study is a prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.

NCT02126943

SPHERE (Uptravi® (SelixiPag): The Users Drug Registry)

This registry is being conducted in order to further outline the clinical characteristics, outcomes and dosing/titration regiments of patients treated with Uptravi in routine clinical practice.

FMD Registry

Data registry to determine the natural course of fibromuscular dysplasia and to determine which procedures are more effective to relieve symptoms and reduce adverse outcomes.

cVAD Registry (Previously USPella)

The USpella Registry is a multi-site retrospective, observational registry for collection of data for patients who have been supported with the Impella 2.5, Impella 5.0/LD or Impella CP cardiac assist device and treated per the institution’s standard of care. The data collection involves medical chart reviews and transcription of de-identified data onto a set of case report forms.

LIFE Study/HFN-LIFE

This study’s primary objective is to determine whether, in patients with symptomatic, advanced heart failure due to left ventricular systolic dysfunction, treatment with LCZ696 for 24 weeks will improve Pro-B-type Natriuretic Peptide (NT-proBNP) levels, which reflect hemodynamic and clinical status, compared to treatment with valsartan.

invested

INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure. The trial will enroll 9300 participants over one Vanguard (pilot) season and three additional influenza seasons.

Please note: we only enroll/recruit patients between the months of August & December.

PREVENT II

PREVENT II is a prospective study of subjects receiving the HM II LVAD as per the current FDA approved indications for use that will investigate if subjects in the Treatment Arm (Warfarin + placebo) experience a reduced incidence of non-surgical bleeding without an increased risk of thromboembolic events.

VICTORIA

VICTORIA will test the hypothesis that vericiguat is superior to placebo in increasing the time to first occurrence of the composite of cardiovascular (CV) death or heart failure (HF) hospitalization in participants with HFrEF.

HALO

The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the Amulet device or the WATCHMAN device and will be followed for 5 years after device implant.

Amulet™ (AMPLATZER™ Amulet™ LAA Occluder Trial (Amulet IDE))

The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the Amulet device or the WATCHMAN device and will be followed for 5 years after device implant.

Stenting and the effects of the Wingspan Stent System with Gateway PTA Balloon Catheter

The Wingspan Stent System with Gateway PTA Balloon Catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries prior to stenting for the purpose of improving intracranial perfusion. This device is authorized by federal law for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, intracranial vessels with ≥50% stenosis that are accessible to the system.