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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…

A prospective cohort study to investigate the use of αvβ3-integrin scintigraphic imaging with 99mTc-NC100692 injection as a surrogate endpoint for therapeutic interventions in patients with myocardial infarction.

To investigate whether the extent of myocardial αvβ3 expression visualized by imaging with 99mTc -NC100692 Injection can be used as a surrogate endpoint for the outcome of therapeutic interventions, using standard and novel treatments (ACE-I vs. ACE…

Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo. Having finished this proof-of-concept
study it is intended that patients will continuously be treated in an open label
extension on a voluntary basis.

The aim of this Phase II proof of concept study is to assess efficacy, haemodynamics and safety of Terguride vs. placebo in patients with pulmonary arterial hypertension (PAH). Having finished this proof-of-concept study it is intended that patients…

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of 2 Doses of RO4905417 (R1512) Administered to Patients with Non ST-Elevation Myocardial Infarction (Non-STEMI) Undergoing Percutaneous Coronary Intervention (PCI)

The primary efficacy objective of this study is:• To evaluate the efficacy of RO4905417 in reducing the procedural damage during PCIThe secondary efficacy and safety objectives of this study are: • To evaluate the changes in other cardiac and renal…

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…

cGMP Enhancing Therapeutic Strategy for HFpEF: The cGETS Study;An interventional, single blind, multicentre study.

The present study protocol proposes a novel cGMP Enhancing Therapeutic Strategy (cGETS) to 1) enhance plasma levels of cGMP, 2) to increase cGMP-related control of the myocardial response to low dose dobutamine stress testing, 3) to improve…

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…

Effects of acute and chronic oral administration of S 44121 versus placebo on cardiac arrhythmia during exercise testing in patients with catecholaminergic polymorphic ventricular tachycardia type 1 - A randomized, parallel-group, international multicentre study including a 8-week double-blind placebo controlled period followed by a 8-week single-blind period - Phase II exploratory study

The objective of this study is to assess the effects of a single and chronic oral administration of S 44121 versus placebo on the occurrence of cardiac arrhythmia during standardized exercise tests (ETs) in patients with CPVT type 1. The safety…

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure

The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure.Secondary:*…

ACT Catheter System in Atrial Flutter, Advanced Cardiac Therapeutics: CE Trial Clinical Study

This study is intended to assess the safety and performance of the ACT Catheter for ablation of right atrial isthmus dependent flutter, also known as typical atrial flutter.

Effects of Sildenafil on pulmonary artery pressure in patients with heart failure with preserved ejection fraction and pulmonary hypertension

Primary objectiveTo investigate wether Sildenafil treatment results in a reduction of pulmonary artery pressure without decrease of cardiac output in HFpEF patients with PHSecondary objectivesTo investigate wether Sildenafil treatment results in a…

A single blind, placebo controlled pilot study to explore the safety and tolerability of a single oral dose of 30 mg BAY 1067197 in patients with chronic heart failure on the background of preexisting beta-blocker therapy

PrimaryThe objective of the study is to investigate the safety and tolerability of the partial adenosine A1 agonist BAY 1067197 on top of standard therapy in patients with chronic systolic heart failure.SecundaryPharmacodynamische en hemodynamische…

A multicenter, double blind, randomized, parallel group, placebo-controlled study to evaluate the hemodynamic responses to intravenous RLX030 infusion in subjects with acute heart failure.

Primary objective(s)• To assess the effects of RLX030 compared to placebo on hemodynamic variables (PCWP, CI) during the first 8 hours administered as i.v. infusion over 20 hours in subjects with Acute Hart FailureSecondary objective(s)• To assess…

Plaque stabilization and restoration of vascular function by bioresorbable vascular scaffold in acute coronary syndrome prone patients

To assess if treatment of an intermediate vulnerable coronary lesion in symptomatic patients using a BVS is feasible, results in a more stable plaque, increases vessel luminal area, preserves or improves vasomotion and is not associated with…

Shockwave treatment for advanced angina in Maastricht (SWAAM). A double blind randomised study.

Goal of the project is to implement the shockwave therapy for no-option CAD patients and to evaluate its potential benefit on regional myocardial perfusion, on regional myocardial function and on the potential improvement in symptoms and quality of…

Feasibility trial of a staged epicardial and endocardial approach for treatment of patients with persistent or long standing persistent atrial fibrillation with radiofrequency ablation

To assess the safety and technical feasibility of treating subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation in a minimally invasive thoracoscopic ablation procedure utilizing the AtriCure Bipolar System,…

Can HDL Infusions Significantly Quicken Atherosclerosis Regression?
A phase II, Multi-center, double-blind, ascending dose, placebo-controlled, dose-finding trial of CER-001 or placebo in subjects with acute coronary syndrome.

To assess the impact of six IV infusions of 3, 6, or 12 mg/kg of CER-001 or placebo, given at weekly intervals, on atherosclerotic plaque volume, as measured by coronary IVUS.

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.