163 results
In this study, our objective is to demonstrate that a tailored ablation strategy targeting areas exhibiting spatio-temporal dispersion in association with PVI, is superior to an anatomical probabilistic ablation strategy targeting PVI alone for the…
The AdaptResponse study is a prospective, randomized, controlled, interventional, single-blinded, multi-center, post-market, global Cardiac Resynchronization Therapy (CRT) in heart failure (HF) clinical study. The purpose of this clinical study is…
to compare the efficacy and safety of complex fractionated atrial electrocardiograms (CFAEs) guided ablation to pulmonary vein isolation based ablation in patients with persistent atrial fibrillation (AF).
• Demonstrate that PCI guided by iFR Co-registration is associated with superior clinical outcomes compared to PCI guided by angiography alone• To evaluate the cost-effectiveness of physiology guidance with SyncVision compared to a standard of care…
Primary Objective: To prove that in patients with multivessel coronary disease (MVD) (>= 2 lesions with diameter stenosis >=50%) a PCI revascularization strategy based on revascularisation of all lesions presenting a vulnerable plaques…
To demonstrate safety and efficacy of Firehawk® rapamycin eluting stent system in comparison to currently approved 2nd generation DESin wide clinical use.
In this study we will compare a hybrid DEB strategy with a conventional bailout 2-stent strategy (TAP/T-stenting or Culotte) in patients with a bifurcation lesion with sub-optimal side-branch result. The primary endpoint will be the composite…
The primary objective is to demonstrate the safety and efficacy of the BuMA DES in patients with functionally significant ischemia requiring percutaneous coronary intervention (PCI) with implantation of drug eluting stents for the treatment of…
To demonstrate the safety and efficacy of the SELUTION SLR* 014 DEB for treatment of bare-metal or drug-eluting in-stent restenosis (ISR).
The purpose of the current investigation is therefore to prove the short-term equivalence and long-term benefit of the ABSORB scaffold over a Xience in patients at high risk of restenosis or with complex lesion(s).Diabetic substudyTo assess the…
The objective of this clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI…
Superiority of stent apposition as assessed by OCT
The purpose of this study is to investigate how safe the new compound BAY 2413555 is and how well it is tolerated when it is administered as a single oral dose to healthy volunteers. BAY 2413555 has not been administered to humans before. It has…
To test the efficacy and cost-effectiveness of using CytoSorb in preventing vasoplegia in patients with heart failure undergoing cardiac surgery on CPB.
To test whether immediate complete revascularization is non-inferior to staged (but within six weeks after index procedure) complete revascularization in ACS patients with multivessel disease
The four principle objectives of this study are:1. To investigate the efficacy of Cytosorb® treatment in attenuating perioperative changes in IL-6 during CF-LVAD implantation 2. To investigate the feasibility, and safety of Cytosorb® treatment…
This PIONEER IV trial aims to demonstrate a non-inferiority of QFR-guidance PCI to usual care PCIwith respect to Patient oriented Composite Endpoint (PoCE) at 1 year with the unrestricted use ofHT Supreme-SES in an all-comers population (including…
To evaluate the safety, effectiveness and performance of the DESyne BDS Plus DECSS (Test) as compared to the CE Mark approved DESyne X2 Novolimus Eluting Coronary Stent System (DESyne X2 NECSS; DESyne X2) (Control) in the treatment of de novo native…
The here proposed randomized clinical trial, named *POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients II* (POSITiVE II), compares INTELLiVENT-ASV with conventional ventilation in patients planned for elective cardiac…
Primary Objective: What is the residual heparin concentration in autotransfusion system product in cardiothoracic surgery? Secondary Objective(s): 1. What is the outcome of the anti Xa determination? 2. How much residual heparin concentration does…