24 results
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…
Assess if CIN prophylaxis for CTA and a TAVI procedure with a 1 -hour sodium bicarbonate protocol is non-inferior in terms of decline in eGFR and serum creatinine level to the 24 hour saline protocol. in pre-operative screening for TAVI and actual…
The purpose of this investigation is to evaluate decellularized homograft for aortic valve replacement (ARISE AV) rates in comparison to current valve substitutes within a large prospective multicentre surveillance at 6 leading European Centres for…
The objective of the BRAVO 2/3 study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR).
The purpose of this investigation is to evaluate the ESPOIR PV in comparison to current valve substitutes within a large prospective multicentre surveillance at 8 leading European Centres for Congenital Cardiothoracic Surgery regarding re-operation…
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…
The purpose of this study is to confirm/validate predicted dabigatran trough plasma levels gained after individual dose assignment based on simulations by means of PK data from the RE-LY trial. Based on this validation a final appropriate dosing…
The objective of this study is to determine if patients without heart failure receiving Sevoflurane have a different myocardial ischemia-reperfusion injury and/or systemic inflammatory response than patients who do not receive Sevoflurane.
The primary objective of this trial is to test the safety and efficacy of Perceval valve versus standard sutured stented bioprosthetic aortic valves among the intended trial population. The secondary objective is to compare all relevant device and…
To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE).To assess the primary bleeding events (PBE) of…
To assess the safety and efficacy of the TriGuard HDH embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with an active control group of patients undergoing unprotected TAVI.
The primary objective of this study is to compare in a non-inferiority design the safety and efficacy of iwFR (or comparable resting diastolic indices)-guided complete revascularization after (within 1-45 days) with iwFR (or comparable resting…
To investigate whether FFR-guided PCI and TAVI strategy for treatment of MVD and AS will be non-inferior to CABG and SAVR for a composite primary endpoint of all-cause mortality, stroke, myocardial infarction, coronary or valve re-intervention and…
To investigate whether the collagen-based MANTA vascular closure device (VCD) is superior to suture-based VCDs in preventing vascular access site complications in patients undergoing transfemoral transcatheter aortic valve replacement.
To assess the safety and efficacy of a *minimally-invasive upper extremity* approach (radial artery for pigtail catheter and brachial vein for temporary pacemaker when not pacing over the left ventricular stiff wire OR radial artery and pacing over…
The purpose of this trial is to evaluate the safety and effectiveness of the Medtronic Evolut PRO+ and Evolut FX TAVR system and guideline-directed management and therapy (GDMT) compared to GDMT in patients with moderate, AS. Data will be used to…
To test whether valve surgery plus medical therapy is superior to medical therapy alone for treatment of endocarditis.
The primary objective is to determine to what extent T-TEER on top of SOC reduce mortality and hospitalizations for heart failure, and improve QoL at 12 months, compared to SOC alone, in patients with severe symptomatic tricuspid valve regurgitation…
Demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is non-inferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low…
Demonstrate that the self-expandable Allegra TAVI system provides lower mean gradient assessed by TTE compared to balloon-expandable valve systems in a population of all women patients with symptomatic severe aortic valve stenosis.