124 results
Functional mitral regurgitation is associated with an adverse prognosis in the heart failure patient. The objective of this study is to evaluate whether PTMA is effective in reducing mitral regurgitation in heart failure patients and whether this…
Study Purpose and ObjectivesStudy PurposeTo confirm the clinical safety and effectiveness of the Trifecta valve by establishing associated adverse event rates, clinical status as indicated by NYHA functional classification, hemodynamic performance,…
The objective is to assess the degree of under- and overexpansion and malapposition of the CRS after implantation, and to come with a proposal of sizing based upon observations made in a (large) prospective clinical data set-experience. For this…
The objectives of the study are to evaluate the performance and safety of percutaneous implantation of the PAV. Primary endpoints will be assessed at discharge and at 30 days (acute benefits), secondary endpoints will be assessed at 3, 6, 12, 24, 36…
To evaluate the safety and effectiveness of the ATS 3f Enable* Aortic Bioprosthesis equine pericardial stented bioprosthesis in a patient population undergoing isolated aortic valve replacement with or without concomitant procedures.
Evaluation of the morbidity and mortality rate at 3 and 12 month follow-up in patients implanted with Freedom SOLO prosthesis.
The purpose of this study is to assess the safety and performance of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transapical Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).
The primary objective of this study is to evaluate the safety and performance of the Permaseal device for left ventricular transapical access and closure and to gain data that will lead to CE-Mark approval for the Permaseal device.
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 primary objective of the study is to generate safety and performance data for the CardiAQ* Transcatheter Mitral Valve Implant System with the Transapical Delivery System to support a future marketing application for the treatment of moderate to…
Primary Objective: The association between the functional improvement (change in VO2 max) and DSE parameters will be determined. In this way the diagnostic characteristics of DSE will be investigated.Secondary Objective(s): The influence of the…
To evaluate long-term clinical and echocardiographic outcome after restrictive mitral annuloplasty for functional mitral regurgitation.
The exact mechanism behind the observed fast recellularization of the DTEHV constructs is still unknown. A reasonable explanation might be that scaffold remnants inside the tissue-engineered constructs recruit the circulating blood cells. In order…
To study the effect of the MitraClip implantation on myocardial performance as determined by changes in left ventricular end diastolic volume and myocardial perfusion.
The main objective is to assess the long-term quality of life, as assessed with the SF-36v2* Health Survey, mortality and the cardiac functions as assessed with an echocardiogram in asymptomatic patients with severe aortic stenosis. Moreover,…
The purpose of this study is to assess the safety and performance of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).
The objective of this prospective, multi-center trial is to assess the effectiveness of the Carillon Mitral Contour System in treating patients with moderate-to-severe atrial functional mitral regurgitation (aFMR).
To establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are not preferred/appropriate due to…
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…
the objectives of the CP-TAVI II study are 1A) to identify whether an increase in cardiac output after TAVI is associated with an increase of global CBF; 1B) explore regional differences in CBF after TAVI; 1C) determine whether (global or regional)…