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A single center, randomized, open-label, cross-over exploratory study to evaluate the pharmacodynamic and pharmacokinetic response to a subcutaneous administration or oral administration of furosemide in subjects presenting with chronic fluid overload

Primary Objective • To assess the effects of 80mg of furosemide delivered by subcutaneous delivery in the abdominal area over 5 hours when compared to oral administration in patients with heart failure with chronic fluid overload. Secondary…

Bioprofiling response to mineralocorticoid receptor antagonists for the prevention of heart failure. A proof of concept clinical trial within the EU FP 7 *HOMAGE* programme « Heart OMics in AGing

Main objective: To investigate whether spironolactone can favourably alter extra-cellular matrix remodelling, assessed by changes in the fibrosis biomarker Procollagen Type III N-Terminal Peptide (PIIINP), in patients at increased risk of developing…

Renal Nerve Stimulation and Renal Denervation in Patients with Sympathetic Ventricular Arrhythmias

This study will investigate the effects of renal nerve stimulation before and after percutaneous transluminal renal denervation on cardiac excitable properties including induction of ventricular tachy-arrhythmias before and after renal denervation…

GENETIC-AF * A Genotype-Directed Comparative Effectiveness Trial of Bucindolol and Toprol-XL for Prevention of Symptomatic Atrial Fibrillation/Atrial Flutter in Patients with Heart Failure

The primary objective of this study is to compare the effects of bucindolol and metoprolol onthe recurrence of symptomatic AF/AFL in patients with HFREF who have a *1389 arginine homozygous(*1389Arg/Arg) genotype.The secondary objectives of this…

A multicenter, prospective randomized study to compare vascular healing after deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered Sirolimus Eluting Stent) versus the Everolimus Eluting Stent in patients with Acute Coronary Syndrome by means of Optical Coherence Tomography

See also page 19 (section 6) of the protocol:6. Study ObjectiveIt is the objective of this study to assess vascular healing by Optical Coherence Tomography (OCT) analysis after deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo…

CLINICAL INVESTIGATION OF A DES (MISTENT* SYSTEM) WITH SIROLIMUS AND A BIOABSORBABLE POLYMER FOR THE TREATMENT OF PATIENTS WITH DE NOVO LESIONS IN NATIVE CORONARY ARTERIES

The primary objective of this study is to demonstrate whether the MiStent Drug Eluting Coronary Stent System can safely and effectively improve coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo…

A RANDOMIZED, PARTIALLY-BLINDED, MULTI-CENTER, ACTIVE-CONTROLLED, DOSE
RANGING STUDY ASSESSING THE SAFETY, EFFICACY, AND PHARMACODYNAMICS OF THE
REG1 ANTICOAGULATION SYSTEM COMPARED TO UNFRACTIONATED HEPARIN OR LOW
MOLECULAR HEPARIN IN SUBJECTS WITH ACUTE CORONARY SYNDROME

To evaluate the safety and efficacy of the REG1 Anticoagulation System in Acute Coronary Syndrome patients undergoing cardiac catheterization by determination of the clinically acceptable dose range of RB007, which can be used to reliably reverse…

Prospective, multi-center, randomized, heparin-controlled dose-finding trial to evaluate the efficacy and safety of rivaroxaban, a direct factor Xa inhibitor, on the background of standard dual antiplatelet therapy to support elective percutaneous coronary intervention (X-Plorer).

The aim of this study is to assess whether rivaroxaban, as compared to UFH, on the background of standard dual antiplatelet therapy (DAPT), can effectively suppress thrombosis, and related adverse ischemic events, upon balloon inflation and stent…

Canyon-I-Pilot Trial a dose-ranging study of bolus-only Desirudin in patients undergoing PCI

The aim of this study is to find out if a percutaneous angioplasty can be carried out safely in patients who received a therapeutic dose of Desirudin (Revasc®) before the operation.

A 36-week, randomized, double-blind, multi-center, parallel group, active controlled study to evaluate the efficacy, safety and tolerability of LCZ696 compared to valsartan in patients with chronic heart failure and preserved left-ventricular ejection fraction.

To demonstrate the efficacy of LCZ696 in patients with chronic heart failure with preserved ejection fraction (HF-PEF) by testing the hypothesis that the reduction in NT-proBNP from baseline to study end with LCZ696 is greater than that with…

A Prospective, Randomized Study to Evaluate the Safety and Effectiveness of
an AbluMinal Sirolimus CoatED Bio-Engineered StEnt (Combo Bio-
Engineered Sirolimus Eluting Stent) Compared with a TAXUS® Liberté® Stent
Control Arm for Treatment of Stenotic Lesions in Native Coronary Arteries

The primary objective of this clinical trial is to demonstrate the safety and effectiveness of the Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent) compared to the commercially available TAXUS® Liberté® Paclitaxel-Eluting Stent (DES) in…

Extension trial to evaluate long term safety of patients randomised into 1160.113 RE-ALIGN study
(RE-ALIGN-EX)

The goal of this trial is to collect long-term observational data on the tolerability, safety and efficacy of dabigatran etexilate in a spectrum of patients receiving bileaflet mechanical heart valves. All patients that have completed study 1160.113…

A randomized, controlled study to evaluate the safety and cardiovascular effects of Algisyl-LVR* as a method of left ventricular augmentation in patients with dilated cardiomyopathy (AUGMENT-HF)

The objective of the AUGMENT-HF study is to provide evidence for the safety profile associated with the Algisyl-LVR* device and initial evidence for the efficacy of the device.

COSIRA - COronary SInus Reducer* for Treatment of Refractory Angina

The objective of this study is to confirm the safety and effectiveness of the Reducer when used in patients with refractory angina who demonstrate evidence of reversible ischemia.

A Randomised, phase II study to Evaluate the sAfety of oraL dabIGatran etexilate in patients after heart valve replacemeNt. (RE-ALIGN)

The purpose of this study is to confirm/validate predicted dabigatran trough plasma levels gained after individual dose assignment based on simulations by means of PK data from the RE-LY trial. Based on this validation a final appropriate dosing…

Study of Myocardial Recovery after Exercise Training in Heart Failure

The extent of beneficial effects of AIT, including reverse remodeling and improved left ventricular function, exercise capacity, quality of life and level of physical activity, needs to be established in a phase II type clinical multicenter study…

Protect: Clinical evaluation of pacing during the onset of revascularization. Clinical feasibility study

The purpose of this study is to determine whether the application of ventricular pacing during PCI for AMI can protect the human heart from damage as a result of ischemia/reperfusion injury

Rheos Diastolic Heart Failure Trial

The purpose of this clinical investigation is to describe the safety and efficacy of the Rheos Baroreflex Activation Therapy System in subjects with diastolic heart failure.

A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel-group, Multicenter Study to Compare the Safety of Rivaroxaban versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Subjects with Acute Coronary Syndrome

To estimate the bleeding risk with rivaroxaban, compared with ASA, in addition to a singleantiplatelet agent (clopidogrel or ticagrelor), in subjects with a recent ACS .

Prospective, multi-center, randomized First-In-Man trial to compare the safety and efficacy of BuMA Supreme eG (Electro Grafting) based biodegradable polymer Sirolimus-eluting stent against Resolute Zotarolimus-eluting durable polymer stent in patients with de novo coronary artery lesions.

To evaluate the safety and effectiveness of the SINOMED BuMA Supreme Sirolimus-Eluting Coronary Stent System with biodegradable polymer versus the Medtronic Resolute Zotarolimus-Eluting Coronary Stent System through angiographic and clinical…