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Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve.

The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.

Early Beta blocker Administration before reperfusion in patients with ST-Elevation Myocardial Infarction who are planned to undergo primary PCI

The primary objective of this randomized trial is to assess the beneficial effects of early administration of 5 mg Metoprolol intravenously before reperfusion on infarct size in patients with ST elevation myocardial infarction who are planned to…

REPRISE III: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus* Valve System - Randomized Clinical Evaluation

The objective of the REPRISE III trial is to evaluate the safety and effectiveness of the Lotus* Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered…

GLOBAL LEADERS: Comparative effectiveness of 1 month of ticagrelor plus aspirin followed by ticagrelor monotherapy versus a current-day intensive dual antiplatelet therapy in all-comers patients undergoing percutaneous coronary intervention with bivalirudin and BioMatrix family drug-eluting stent use.

To determine in all-comers patients undergoing PCI under standardised treatment (including the BioMatrix family of drug-eluting stents and bivalirudin), whether treatment with 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor…

A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Oral Rivaroxaban with Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects with Chronic Heart Failure and Significant Coronary Artery Disease Following a Hospitalization for Exacerbation of Heart Failure

The primary objective is to demonstrate that rivaroxaban is superior to placebo in subjects with chronic HF and significant CAD, who are receiving standard care, in reducing the risk of the composite of ACM, MI, or stroke following a recent…

AdreView* Myocardial Imaging for Risk Evaluation * A multicentre trial to guide ICD implantation in NYHA class II & III heart failure patients with 25% * LVEF * 35%. ADMIRE-ICD

To demonstrate the efficacy of AdreView* imaging for appropriately guiding the decision of ICD implantation in a population of New York Heart Association (NYHA) class II and III Heart Failure (HF) patients with 25% * left ventricular ejection…

An OPen-label, Randomized, Controlled, Multicenter Study ExplorIng TwO TreatmeNt StratEgiEs of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention - PIONEER AF-PCI

In this study, the main clinical hypothesis is that the TIMI clinically significant bleeding rates will not be different between the rivaroxaban and VKA treatment strategy groups at Month 12.

A multicenter, randomized, double-blind, double-dummy, parallel-group, active-controlled study to evaluate the efficacy and safety of finerenone compared to eplerenone on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction after recent heart failure decompensation and additional risk factors, either type 2 diabetes mellitus or chronic kidney disease or both.

Demonstrate the superiority of finerenone to eplerenone in delaying time to first occurrence of the compositeendpoint, defined as cardiovascular (CV) death or hospitalization for heart failure (HF), in patients withCHF (NYHA class II-IV) and reduced…

Pre-emptive, OCT guided angioplasty of vulnerable, intermediate coronary lesions: a randomized trial

To determine the effect of the stenting of intermediate, vulnerable coronary lesions on the prevention of future ACS, in patients with residual non-obstructive CAD after PCI for myocardial infarction.

A prospective Randomised, open label, blinded endpoint (PROBE) study to Evaluate DUAL antithrombotic therapy with dabigatran etexilate (110mg and 150mg b.i.d.) plus clopidogrel or ticagrelor vs. triple therapy strategy with warfarin (INR 2.0 - 3.0) plus clopidogrel or ticagrelor and aspirin in patients with non valvular atrial fibrillation (NVAF) that have undergone a percutaneous coronary intervention (PCI) with stenting

See section 2.2 of the protocol.The main objective of this study is to compare a DAT regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg DE-DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (…

A placebo-controlled, double-blind, randomized trial to evaluate the effect of 300 mg of inclisiran sodium given as subcutaneous injections in subjects with Atherosclerotic cardiovascular disease (ASCVD) or ASCVD- risk equivalents and elevated low density lipoprotein cholesterol (LDL-C)

The primary objective of this study is to evaluate the effect of inclisiran treatment on:•LDL-C levels at Day 510•Time adjusted percent change in LDL-C levels from baseline between Day 90 and Day 540 levels. The secondary objectives of this study…

The PACE NOW Trial: A Prospective, rAndomized Comparison of tEmporary transvenous pacing and leadless paciNg therapy in pOst-TAVI patients With conduction abnormalities

The primary objective of the study is to outline the advantages of LP implantation in TAVI patients who require temporary, and possibly permanent pacing compared to the Standard of Care using TV-TP therapy. We will study whether placement of a LP…

A placebo-controlled, double-blind, randomized trial to evaluate the effect of 300 mg of inclisiran sodium given as subcutaneous injections in subjects with Atherosclerotic cardiovascular disease (ASCVD) or ASCVD- risk equivalents and elevated low density lipoprotein cholesterol (LDL-C)

The primary objective of this study is to evaluate the effect of inclisiran treatment on:*LDL-C levels at Day 510*Time adjusted percent change in LDL-C levels from baseline between Day 90 and Day 540 levelsThe secondary objectives of this study are…

A multicenter, randomized, double-blind, placebo- controlled phase III study to evaluate the efficacy, safety and tolerability of Serelaxin when added to standard therapy in acute heart failure patients

Primary Objective:To demonstrate that serelaxin is superior to placebo in reducing CV death in AHF patients during a follow-up period of 180 days.To demonstrate that serelaxin is superior to placebo in reducing worsening heart failure through Day…

SYMPTOMATIC IMPROVEMENT BY PERITONEAL DIALYSIS IN PATIENTS WITH END STAGE CONGESTIVE HEART FAILURE

To improve symptomatology in severe chronic failure patients.

European Ambulance Acute Coronary Syndrome Angiox Trial: EUROMAX

The purpose of the trial is to show that the early administration of bivalirudin improves 30 day outcomes when compared to the current standard of care in patients with STE-ACS, with an onset of symptoms of >20 minutes and <12 hours,…

A prospective, randomised, open-label, blinded endpoint evaluation (PROBE) parallel group study comparing edoxaban (DU-176b) with enoxaparin/warfarin followed by warfarin alone in subjects undergoing planned electrical cardioversion of nonvalvular atrial fibrillation

The primary efficacy objective of this study is to:* Compare the incidences of the composite endpoints of stroke, systemic embolic event (SEE), myocardial infarction (MI) and cardiovascular (CV) mortality between the edoxaban group and the…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Ranolazine on Major Adverse Cardiovascular Events in Subjects with a History of Chronic Angina Who Undergo Percutaneous Coronary Intervention with Incomplete Revascularization

The primary objective of this study is to:• Evaluate the efficacy of ranolazine as compared with placebowhen used as part of standard medical therapy in chronicangina subjects with incomplete revascularization post percutaneous coronary intervention…

A Prospective Multicenter Trial to Assess the Safety and Effectiveness of the
SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System
(SYNERGYTM Stent System) for the Treatment of Atherosclerotic Lesion(s)

To assess the safety and effectiveness of the SYNERGYTM Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) * 34 mm in length (by visual estimate) in native coronary arteries *2.25 mm to *4.0 mm in diameter (by visual…

NANO+_OCT Study

Primary Objective The objective of this study is to evaluate the extent of neointima formation at 3 month after (successful) implantation of the Nano+ stent in a single lesion in elective PCI patients. Secondary Objective To assess if NanoTM Polymer…