28 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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

Leadless II

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

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

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%).

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.

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.

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.