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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.

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…

The REDUCE FMR Trial: Safety and Efficacy of the CARILLON Mitral Contour System in Reducing Functional Mitral Regurgitation (FMR) associated with heart failure.

The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the CARILLON Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart failure, compared to a…

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.

Effect of Bivalirudin on Aortic Valve Intervention Outcomes 2/3

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).

A prospective, single arm feasibility pilot study to evaluate the safety and performance of the TriGuard*-HDH Embolic Deflection Device in patients undergoing Transcatheter Aortic Valve Replacement (TAVR)

To demonstrate the safety and performance of the Embolic Deflection Device (TriGuard*HDH) in patients undergoing Transcatheter Aortic Valve Replacement (TAVI).

Extension trial to evaluate long term safety of patients randomised into 1160.113 RE-ALIGN study
(RE-ALIGN-EX)

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…

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.

A Randomised, phase II study to Evaluate the sAfety of oraL dabIGatran etexilate in patients after heart valve replacemeNt. (RE-ALIGN)

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…

A Study of Percutaneous Left Ventricular Reshaping of Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve LV Function Using the Accucinch System.

The objective of the study is to demonstrate the safety, feasibility and potential efficacy of using GDS Accucinch System in human subjects with heart failure and clinically significant functional mitral regurgitation.

Clinical Evaluation of the Edwards Lifesciences Monarc system for the treatment of Mitral Regurgitation

To demonstrate the safety, efficacy, and performance of the Edwards Lifesciences MONARCTM system for the treatment of functional mitral regurgitation

MERIT Study - Mistral Percutaneous Mitral Valve Repair FIM Study

The study is designed to clinically demonstrate device acute safety (Primary Endpoint) along with longer FU device safety and effectiveness evaluation (Secondary Endpoint).The main objectives of the study areU :1) Evaluate the Acute safety of the…

The effect of Adenosine on Myocardial Protection in Intermittent warm blood Cardioplegia: a randomized placebo-controlled trial

The aim of this study is to determine whether the addition of adenosine to standard intermittent warm blood cardioplegia reduces the 6-hours post-operative cTnT in patients scheduled for minimally invasive, port access operations (mitral valve…

Global multicenter, open-label, randomized, event-driven, active-controlled study comparing a rivAroxaban-based antithrombotic strategy to an antipLatelet-based strategy after transcatheter aortIc vaLve rEplacement (TAVR) to Optimize clinical outcomes.

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…

Cardiac CT for therapeutic stratification in low gradient presumed severe aortic stenosis with preserved left ventricular ejection fraction

Primary objective: The primary objective of this non-randomized intervention trial is to investigate whether TAVR improves exercise capacity in patients with preserved LVEF and NF/LG or LF/LG severe AS reclassified based on hybrid CT/TTE-derived…

Preventing Oxidative stress-induced ischemic injury and systemic inflammation complications during and after invasive cardiac surgery with Alkaline Phosphatase (APPIRED III)

The purpose of this study (APPIRED III) is to investigate the efficacy of administered prophylactically RESCAP with regard to the prevention of (severe) renal failure, or renal dysfunction, reducing morbidity and mortality. It also looks at systemic…

TriGUARD 3 TransCranial Doppler (TCD) Ultrasound Study: A prospective, randomized, real-time evaluation of blood filtration with the TriGUARD 3 Embolic Protection Device Using TCD During Transcatheter Aortic Valve Implantation (TAVI).

To demonstrate that the Cerebral Embolic Protection Device (TriGUARD*3) in patients undergoing Transcatheter Aortic Valve Implantation (TAVI) leads to less brain injury as assessed by transcranial Doppler measurements.

Rotterdam Edoxaban Leaflet Evaluation in Patients after Transcatheter Aortic Valve Implantation

To investigate whether treatment with edoxaban leads to a decrease in incidence of leaflet thickening and is clinical efficient and safe.

IcoSApent ethyL to slow down aortic VAlve stenosis proGrEssion

This study has been transitioned to CTIS with ID 2024-517342-33-01 check the CTIS register for the current data. The primary objective is:• to study the effect of icosapent ethyl on progression of aortic valve calcification.The secondary objectives…

Does colchicine reduce progression of aortic valve stenosis?

This study has been transitioned to CTIS with ID 2024-513486-39-00 check the CTIS register for the current data. The main objective of this study is to determine the effect of colchicine on the progression of moderate AS in asymptomatic patients.