124 results
The goal of this study is to determine if MDMA use is associated with a relevant risk of toxic valvulopathy. The popularity of the drug is attributed to its assumed low-risk profile, but these assumptions could be incorrect due to underreporting of…
- The objective of the proposed clinical trial is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Heart Valve in patients with severe, symptomatic aortic stenosis who are at intermediate or low risk of surgical mortality…
The primary objective of this clinical Research is: • The objective of the study is to investigate concept and feasibility of view automation for SHD interventions. The study will explore the contribution of (semi) automatic views based procedural…
Medtronic, Inc. is sponsoring the SMART Trial, a prospective, multi-center, international, randomized controlled, post-market trial. The purpose of this trial is to generate clinical evidence on valve safety and performance of SE versus BE TAVR in…
This study is intended to collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic…
The rationale for conducting the PARADIGM study is to evaluate the safety and effectiveness of the AVP III for closure of PVLs. Until recently, current treatment in the US and OUS included off-label use of various occluder devices. The study will…
Main objectives of the study can be summarized as follows:1. To thoroughly characterize valve tissue of Barlow*s MR as compared to FED. 2. To investigate the familial distribution of different forms of organic MR and the prevalence of genetic…
The aim of this study is to investigate potential differences in blood flow patterns, wall shear stress and energy loss in patients after mitral valve repair with the resect and respect approach.
Primary objectives: 1. To assess the difference in bioprosthetic leaflet 18F-NaF PET activity, as an early marker of transcatheter valve degeneration, between patients with vs. without SCLT at five years after TAVI.2. To assess the difference in…
The objective of the study is to evaluate the safety and performance of a new Non-Invasive Ultrasound Therapy (NIUT) with Valvosoft® in the treatment of CAS.
The primary objective is to obtain data of invasively measured SAVI in patients with a normal aortic valves undergoing routine, clinically indicated, invasive cardiac catheterization..The secondary objective(s) is/are to investigate the correlation…
Primary objective: to compare the performance of the Symetis ACURATE neo/TF to the Edwards SAPIEN 3 transcatheter aortic bioprosthesis with regard to early safety and clinical efficacy at 30 days Secondary objectives: to compare the Symetis ACURATE…
Evaluate whether patients with elevated Lp(a) are characterized by increased active calcification of the aortic valve.
Primary objective: To generate safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from moderate to severe functional tricuspid regurgitation with annular dilatation. Secondary objective: To evaluate the…
Primary Objective: The aim of the present study is to find which point-of-care test (ACT or aPTT) is superior in predicting bleeding complications within 24h after both TAVI (Cohort A) and CTO PCI (Cohort B) procedure. Secondary Objective(s): The…
1. Studying validity of the 2MST in comparison with CPET2. Studying reproducibility of the 2MST by test-retest3. Studying responsiveness of the 2MST to changes in physical fitness
Primary Safety Objective : To evaluate one month procedural and device safety of the Tendyne Bioprosthetic Mitral Valve System.Primary Safety Endpoint : Device success and freedom from the following device- or procedure-related serious adverse…
This study is designed to assess diagnostic and prognostic value of intracoronary flow- and pressure measurements in patients with severe aortic valve stenosis and concomitant coronary artery disease, unravelling the physiological impact on coronary…
The objective of this study is to evaluate the feasibility and safety of the Millipede Transcatheter Annuloplasty Ring System in patients with functional mitral regurgitation.
To assess procedural hemodynamic indices of paravalvular leakage and to relate these to cardiac MRI at 1 month and clinical follow-up over 5 years.To diagnose angiodysplasia en determine the effect of TAVI on these angiodysplastic lesions.