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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…

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

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.

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.

Management of Atrial fibriLLation INcluding tailoring of anticoagulation in patients from primary care - ALL-IN

To evaluate whether integral AF treatment in primary care is non-inferior in terms of reducing all-cause mortality (primary outcome) and specific cardiac mortality and hospitalization and non-cardiac hospitalization (secondary outcomes), as compared…

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…

Effects of homebased training with telemonitoring guidance in low to moderate risk patients entering cardiac rehabilitation

The objective of the present study is to investigate whether home-based exercise training with telemonitoring guidance results in improved long-term physical fitness and higher activity levels than regular centre-based exercise training in patients…

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…

A Prospective, Multi-Center, Non-randomized, Single arm, Open label, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross* Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions.

The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross* micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting…

Amsterdam Investigator-initiateD Absorb strategy all-comers trial

Primary Objective: To compare the strategies of treatment with 1. ABSORB everolimus eluting bioresorbable vascular scaffolds and 2. Xience everolimus eluting coronary stent system in a non-inferiority all-comers trial.

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…