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opTimization of timing Window for 18F-FDG PET/CT In patientS with suspecTED prosthetic heart valve endocarditis

Primary objectives of the study are: 1. Defining the optimal image acquisition time window after FDG injection for PET/CT imaging in patients suspected of endocarditis2. Assessing the impact of gating (respiratory and ECG) on PET/CT image quality in…

Mechanistic insights in mitral valve prolapse and associated left ventricular remodelling: Barlow*s Disease versus Fibroelastic Deficiency

Primary Objective:1) Assess different LV loading mechanisms in Barlow's Disease (BD) versus Fibroelastic deficiency (FED), including transvalvular mitral regurgitant and prolapse volume, both with echocardiography and cardiac magnetic resonance…

Real-time Pressure volume Loop monitoring as a guide for enhanced Understanding of changes in elemental cardiovascular physiology during Therapeutic strategies aiming for hemodynamic Optimization. Cohort II: Structural heart interventions (PLUTO-II).

The primary objective of this study is to describe and to quantify the change in cardiac mechanoenergetics, expressed by PVL monitoring (reflected by the parameters stroke work, potential energy and pressure-volume area), in patients undergoing…

ARB-PMCF STUDY: ANNULOPLASTY RINGS & BAND POST-MARKET CLINICAL FOLLOW-UP STUDY

The goal of the ARB-PMCF study is to evaluate the safety and performance of Abbott annuloplasty devices used in the surgical repair of mitral and tricuspid regurgitation for five years from implantation.The ARB-PMCF study aims to meet the EU Medical…

Assessment of the safety and performance of the HARPOON* Beating Heart Mitral Valve Repair System; a multi-center post-market study (The ASCEND Study).

To evaluate the long-term safety and performance of the HARPOON* MVRS for use in patients presenting with severe degenerative mitral regurgitation due to posterior leaflet prolapse in the post-market phase.

Balloon Expandable vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis

To compare safety and efficacy of EVOLUT R/Pro vs. SAPIEN3 Ultra for the treatment of a failing surgical aortic bioprosthesis

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.

ACURATE neo2 PMCF: ACURATE neo2* (S2410): Post Market Clinical
Follow-up Study

To collect clinical and device performance outcomes data with the ACURATE neo2* Transfemoral Aortic Valve System as used inroutine clinical practice for the treatment of severe calcific aortic stenosis.

Coagubility in severe mitral regurgitation: A within-patient evaluation of coagulation status before and after Mitral Valve Transcatheter Edge-to-Edge Repair.

To evaluate coagulation status in patients with moderate-severe to severe MR, with concomitant atrial enlargement or atrial fibrillation, before and after M-TEER to explore the complex relationship between MR and coagulability.

Clinical Investigation of the Freedom SOLO stentless Heart valve

To demonstrate the safety and effectiveness of the Freedom SOLO heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis. Safety will be determined by survival and complication rates. Echocardiography and…

INVAsive, ultraSOUND and MRI assessment of transvalvular gradients after transcatheter aortic valve implantation

The INVA-SOUND-MRI (INVAsive, ultraSOUND and MRI assessment of transvalvular gradients after transcatheter aortic valve implantation) study aims to elucidate: 1) The accuracy of transaortic gradient assessment with different modalities (invasive,…

Transcatheter Mitral Valve Replacement with the Medtronic Intrepid* TMVR Transfemoral System in patients with severe symptomatic mitral regurgitation - APOLLO-EU Trial

Evaluate the safety and efficacy of Medtronic Intrepid* TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation who, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of…

European First in Human Study of the NeoChord Transcatheter Mitral Repair System to Assess Safety and Performance in Patients with Mitral Regurgitation

The objective of this First-in-Human (FIH) evaluation is to assess the safety and performance of transcatheter based mitral repair in subjects with mitral regurgitation.

STRESS AORTIC VALVE INDEX FOR ASSESSING RISK IN AORTIC VALVE STENOSIS PATIENTS

The goal of this study is to demonstrate the value of SAVI (both non-invasive and invasive) in patients with moderate aortic stenosis. The short-term objective will compare SAVI with standard resting indexes for symptom burden, functional capacity,…

A First-in-Human Study to Assess Safety and Performance of the Cardiac Implants Percutaneous Ring Annuloplasty System in the Treatment of Patients with Functional Tricuspid Regurgitation

The objective of this study is to evaluate the safety and performance of the DaVingi* TR System for the treatment of patients with functional tricuspid regurgitation within its intended use.The study will:• Evaluate the safety and feasibility of…

Prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Man.

Primary Study Objectives:Safety objective: assessment of procedure related mortality up to 30 days post-procedure.Performance objective: demonstration of the ability of Valvosoft to modify the structure of the calcified valve leaflets to improve…

Waveform Analysis for Vascular Evaluation and Cardiovascular Advancements in Research and Enhancement

Primary Objective:Our overall aim is to develop an easy-to-use, and interpretive method for the early detection of valvular heart disease and thoracic aortic aneurysm based on arterial blood pressure waveforms, collected non-invasively. Therefore,…

InvEstigation of the safety and perforMance of the NVT ALLEGRA THV System with a new delivery system in Patients with severe calcified aortIc stenosis or failed suRgical aortic bioprosthEsis

Confirm the technical performance of the new IMPERIA Delivery System and evaluate the safety and efficacy of the entire ALLEGRA THV System.

Corcym Mitral, Aortic aNd Tricuspid post-maRket Study in a reAl-world setting

Monitor ongoing safety and performance of the CORCYM heart valve devices and accessories for aortic, mitral and tricuspid valvular diseases in a real-world setting.

A Prospective, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Transcatheter Aortic Valve Implantation in Female Patients who have Severe Symptomatic Aortic Stenosis Requiring Aortic Valve Replacement

Purpose of this prospective, randomized, controlled, multi-center study is to evaluate the safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) as compared to surgical aortic valve replacement (SAVR) in female patients with severe…