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The "Spacemaker": evaluating a new surgical lung spatula for an optimal fit

In our current study we would like to evaluate a newly developed surgical platform for minimal invasive cardiothoracic surgery: the soft tissue expander. Main objective of the study is to determine the feasibility of creating a trans tissue expander…

Understanding Outcomes with the EMBLEM* S-ICD in Primary Prevention Patients with Low Ejection Fraction

The primary objective is to assess the 18-month incidence of inappropriate shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) programmed with zone cutoffs at 200 bpm and 250 bpm and:- an indication for…

BIOFLOW-V: BIOTRONIK * A Prospective Randomized Multicenter Study to Assess the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions * V

To assess the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or restenotic (standard PTCA only) coronary artery lesions compared to the Xience coronary stent…

Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an
All COmeRs PopulaTion (BIO-RESORT): Randomized Multicenter Trial in an All Comers Population Treated Within thE NeThErlands 3 (TWENTE 3)

The aim of the study is to compare the outcome of two DES with biodegradable polymer coatings separately (Orsiro and Synergy) versus an established third-generation durable polymer DES with proven efficacy and safety (Resolute Integrity) in an all…

Imaging and Modeling to investigate the mutual relationship of Plaque growth and biomechanical parameters in human coronary arteries

To investigate the association between shear stress and plaque growth and plaque composition changes over time. Furthermore, it will be investigated how these plaque changes influence the local wall stress.

Amsterdam Investigator-initiateD ABSORB trial- AIDA CTO Physiology

To compare the endothelium-dependent and non-endothelium-dependent vasomotion and perfusion restoration in coronary vessels treated with ABSORB BVS or Xience DES in CTO coronary lesions

Aortic Stenosis * Identification of high-risk valve pathology using STRESS physiology (AoS-STRESS)

2.1 Primary objectiveTo determine patterns of response in the transvalvular pressure gradient while altering transvalvular flow.2.2 Secondary objectives-To quantify any added value or differentiation from stress assessment of aortic stenosis…

The treatment of coronary artery lesions using the PRO-Kinetic energy cobalt-chromium, bare-metal stent (BIOHELIX-I)

The primary objective of this study is to demonstrate the clinical performance of PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native coronary arteries.

Four-dimensional flow cardiac magnetic resonance imaging for the assessment of coarctation of the aorta, a monocenter, prospective, diagnostic cross-sectional study.

1. To investigate non-invasive 4D flow CMR for the assessment of aortic arch stenosis and compare and correlate this to conventional imaging modalities and to three-dimensional rotational angiography (3DRA) with computational fluid dynamics (CFD). 2…

Measuring the Activated Clotting Time in patients receiving unfractionated heparin prior to coronary angiography and intervention. A single-centre validation study comparing different blood sampling sites

This study aims at establishing the influence of sampling site on the variability of ACT measurement at the end of coronary angiography or PCI.

Arterial stiffness, Blood Pressure and Cardiac output study; ABC-study;A Prospective, Multidisciplinary study of arterial stiffness measures in patients treated for aortic aneurysms in relation to blood pressure and cardiac output

Zie document PROTOCOL SYNOPSIS ABC study

Randomized Evaluation of Atrial Fibrillation treatment with focal impulse and Rotor Modulation guided procedure ( REAFFIRM)

Primary Objective: Evaluate the safety and effectiveness of FIRM-guided procedures in addition to conventional ablation for the treatment of patients with persistent atrial fibrillation (AF).Secondary Objectives:•Evaluate the acute effectiveness of…

A placebo-controlled, double-blind, randomized trial to compare the effect of treatment on plaque burden as determined by intravascular ultrasound and to evaluate the efficacy, pharmacokinetics, safety, and tolerability of MDCO-216 given as multiple weekly infusions in subjects with a recent acute coronary syndrome.

Primary ObjectivesTo evaluate the effect of MDCO-216 treatment on the change in PAV of a target coronary artery as measured by IVUS imaging following five weekly infusions of MDCO-216 (20 mg/kg) compared with placebo in subjects with a recent ACS.…

Role of different phosphate binders on absorption of vitamin K, metabolism of matrix *-carboxy-glutamaat (Gla) proteïne (MGP).

This research will have as aim to look at progression or decrease of vascular calcification in dialysis population with use of different phosphate binders. There is a possibility that differect phosphate binders bind vitamin K in a different way in…

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.

Right ventricle remodeling after pulmonary valve replacement and percutaneous pulmonary valve insertion, a functional and histopathological assessment.

Primary objectives: to investigate functional and histopathological changes of the right ventricle before and after PVR and PPVI. To investigate if non-invasive assessment of RV-remodeling using CMR T1 mapping and T1rho mapping is possible and to…

Pressure-Flow Measurements Directly after Primary PCI to Predict Late Occurrence of Microvascular Obstruction

In the present study we aim to determine the value of microvascular resistance measurements in the acute setting to predict the occurrence of MVO in the following days, using the combined pressure-flow wire. Therefore patients with an acute MI will…

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…

PVAI alone vs. PVAI plus ablation of complex fractionated atrial electrograms in a specific area of the left atrium in patients suffering from (longstanding) persistent atrial fibrillation.

The aim of this study is to determine if adding ablation restricted to specific areas of the left atrium to PVAI is superior to the standard care PVAI alone.

Cyclopentolate induced EEG changes in children

To compare the EEG pattern after administration of cyclopentolate with the EEG pattern after placebo eye-drops.Primary outcomeEEG pattern changes after administration of two drops of cyclopentolate1% compared with placebo.Secondary outcomes- Pattern…