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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…

A randomized, double-blind, placebo-controlled phase IIIa study of bIAP, an anti-inflammatory moiety, in patients undergoing combined aortic valve replacement and coronary artery bypass grafting.

Primary Objective:The objective of this study is to determine the efficacy of bIAP as a prophylactic agent against inflammation-mediated complications from more invasive cardiac surgery, aortic valve surgery and CABG with cardiopulmonary-bypass time…

REPRISE II: Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System - Evaluation of Safety and Perfomance

To evaluate the safety and performance of the Lotus Valve system for transcathether aortic valve replacment (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

A multi-centre, double-blind, randomised, placebo-controlled trial using CD133 enriched bone marrow cells following primary angioplasty for acute myocardial infarction with central core laboratory analysis.

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The POSTIVE (Pre-Operative STatin InterVEntion) study

This study will test the hypothesis that acute administration of statins will provide for a better protective (anti-inflammatory) effect than chronic administration. Patients used for this study have to undergo mitral and/or tricuspid valve surgery…

Efficacy and safety of Haemocomplettan® P in patients experiencing microvascular bleeding while undergoing elective complex cardiac surgery

To determine whether fibrinogen concentrate infusion reduces perioperative blood loss and transfusion in patient experiencing clinically relevant microvascular bleeding during elective complex cardiac surgery and to determine whether its use is safe…

A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element*) for the Treatment of up to two De Novo Coronary Artery Lesions

To determine the safety and effectiveness of the PROMUS Element* Everolimus-Eluting Coronary Stent System (Boston Scientific Corporation [BSC], Natick, MA) for the treatment of patients with up to 2 de novo atherosclerotic lesions

A Phase III Prospective, Randomized, Double-Blind, Active-Controlled, Multi-Center, Superiority Study of Vernakalant Injection versus Amiodarone in Subjects with Recent Onset Atrial Fibrillation

The primary objective of the study is to demonstrate the superiority of vernakalant injection over amiodarone injection in the conversion of atrial fibrillation (AF) to sinus rhythm (SR) within 90 minutes of the start of drug administration. The…

A randomized open pharmacokinetic pilot study on bIAP, an anti-inflammatory moiety, in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass.

Primary Objective:The objective of this pilot study is to determine whether the observed AP pharmacokinetic profiles in plasma of CABG patients in the APPIRED study can be confirmed in the CABG patients under a non-aprotinin regime.

The effect of two different heart-lung machines, Twin-Pulse Life Support and standard used heart-lung machine, on the systemic inflammation and pattern of microvascular blood flow. A prospective randomised clinical trial.

Analysis of the effects of the Twin-Pulse Life Support on on the systemic inflammatory response and the effect on microvascular blood flow in ocmparison to standard used Extracorporeal Circuit Device

Multicenter, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy, safety and tolerability of tezosentan in patients with pre-operative pulmonary hypertension, due to left heart disease, undergoing cardiac surgery

Primary objective: to demonstrate that tezosentan, in patients undergoing cardiac surgery with cardiopulmonary bypass, reduces the incidence of clinically relevant right ventricular failure resulting in difficult separation from bypass or need for…

A Prospective, Multi-Center, Single Arm Study of the Conor Cobalt Chromium Reservoir Based Stent (Nevo) with Sirolimus Elution in Native Coronary Artery Lesions (CP-07 protocol)

The primary objective of this study is to evaluate the target lesion failure rate of the Conor Sirolimus-eluting Coronary Stent System in lesions up to 28 mm in length in native coronary arteries with a reference vessel diameter of 2.5 mm to 3.5 mm…

Comparison of Biolimus Eluted from a Erodable Stent Coating with Bare-metal Stents in Acute ST-elevation Myocardial Infarction & In Vivo 3-Vessel Assessment of Time-Related Changes of Culprit and Non-Culprit Lessions by Grayscale IVUS, IVUS-VH and OCT in Acute Myocardial Infarction.

To establish superiority of the biolimus-eluting (BiomatrixTM) stent compared with an otherwise identical bare-metal stent (GazelleTM) in acute ST-segment elevation myocardial infarction (STEMI) in terms of the composite endpoint of cardiac death,…

Organ protection by noble gases * A clinical study to investigate Helium induced Pre- and Postconditioning in patients undergoing coronary artery bypass surgery.

The aim of this clinical study is to investigate whether the non-anaesthetic noble gas helium induces preconditioning (PreC) and postconditioning (PostC) in patients undergoing coronary artery bypass graft (CABG) surgery

Preserved platelet function during cardiopulmonary bypass with aprotinin in dual antiplatelet therapy.

Primary objectiveTo determine whether aprotinin can reverse the increased postoperative blood loss, induced by dual anti-platelet therapy in elective non-complex cardiac surgery.Secondary objectiveTo determine whether aprotinin reduces transfusion…

Nitric Oxide during Cardio Pulmonary Bypass during surgery for congenital heart defects: A Randomised Controlled Trial.

Primary objective of this trial is to investigate in a double blind randomized controlled trial in children undergoing open heart surgery if NO exposure during CPB reduces the postoperative duration of invasive mechanical ventilation (defined as…