Clinical Trials

The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical valve replacement.

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT and the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.

A prospective, multi-center study to evaluate the neuro-embolic consequences of Transcatheter Aortic Valve Replacement (TAVR)

The purpose of this study is to evaluate the safety and effectiveness of the Melody Transcatheter Pulmonary Valve used in patients with a dysfunctional bioprosthetic valve.

When the upper chambers of a person's heart receive irregular electrical signals it causes abnormal rhythm in the heart beat. This is called atrial fibrillation. Atrial fibrillation increases the chance of having a heart attack or stroke. Some patients also get new heart valves using a catheter. Often doctors give patients a medicine called a vitamin K antagonist (VKA), because it is considered the standard care. This study will see how edoxaban compares to VKA in patients who got a new heart valve by using a catheter. The study will compare the two drugs for up to three years after ...

The purpose of this study is to establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients who have  severe, symptomatic aortic stenosis and are at low operative risk for standard aortic valve replacement.

The purpose of this study is to evaluate whether simple cardiac exercise interventions to improve physical performance before transcatheter aortic valve replacement (TAVR) surgery improves outcomes after TAVR.

The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo TAVR.

The purpose of this study is to see if , with the help of a new software program to find the aortic valve angles, accurate placement of a new valve can be improved during a total aortic valve replacement procedure.

The purpose of this study is to determine what factors predict poor surgical outcomes, and the extent to which patient-centered outcomes differ between participants deemed frail and non-frail.

The purpose of this study is to identify non-HLA and non-gal protein antigens in transplanted xenogenic tissues (ie bovine or porcine pericardial heart valves) that can then be used to preemptively identify and overcome graft-specific immune responses.

The purpose of this work is to evaluate the feasibility of a new Cardiac Vascular Reconstruction (CAVAREC, Siemens Medical Systems, Germany) image reconstruction algorithm for use during transcatheter aortic valve implant (TAVI) procedures. CAVAREC utilizes the same x-ray projection images as currently acquired for clinical DynaCT. X-ray image acquisition to allow CAVAREC will occur during the TAVI procedure both before and after the TAVI device is implanted. The CAVAREC image processing algorithm will be implemented on an off-line workstation after the TAVI procedure is complete. After the TAVI procedure, CAVAREC images will be quantitatively and qualitatively compared to Siemens DynaCT ...

The purpose of this study is to evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at High Risk for aortic valve replacement surgery.

The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis.

The purpose of this study is to provide a survey to prospective candidates undergoing transcatheter valve replacement or repair at two time-points to assess grit, a psychological composite of personal diligence which has been validated to predict retention in other pursuits of long-term goals over and above assessments limited to intelligence and physical aptitude.

The purpose of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

The purpose of this study is to obtain safety and effectiveness data to support indication expansion for the Medtronic transcatheter aortic valve replacement (TAVR) System to include patients with moderate, symptomatic Aortic Stenosis (AS).

The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.

The purpose of this study is to establish the safety of using Cara™ Monitor used in TAVR, and to estimate the effect of Cara Monitor on reduction of NOCD post TAVR compared to patients treated and followed per regular site-specific practice.

To assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing aortic bioprosthetic valve.

Compare transapical and transfemoral TAVR as regards clinical outcomes (both beneficial including improvement in heart failure class (NYHA) and reduced number of hospitalizations; and adverse including mortality and MACE.) Also, to compare cardiac mechanics’ outcomes in the short and intermediate follow up and correlate the baseline, percent change and final cardiac mechanics values with the clinical outcomes. So that this all comes down to being able to provide these information to the patients if there appeared to be a correlation between cardiac mechanics and clinical outcomes:

The purpose of this study is to compare the hemodynamic effects of Low Flow versus Normal Flow Aortic Stenosis after Transcatheter Aortic Valve Replacement.

This clinical trial is a prospective, randomized, controlled, multi-center study. Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 THV or clinical surveillance. Patients will be stratified by whether or not they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.

There has been a paradoxical finding in clinical trials with severe AS patients that LV mass regression is greater and faster after surgical AVR compared to transcatheter AVR while hemodynamic profile is better after TAVR compared to SAVR. We do have a preliminary finding to explain this paradox and want to validate it.

The aims of this investigation are:

To assess the predictive value (and accuracy) of clinical and physiologic preoperative variables in identifying patients at risk for the development of new-onset atrial arrhythmia after cardiac surgery.

To assess the feasibility of a physiological risk model based on clinical and echocardiographic indexes to predict post-operative AF.

To assess the role of prophylactic agents in the prevention of new-onset postoperative POAF

To assess the economic impact of new-onset postoperative AF:

• Length of hospital stay (will be measured as fractions of days)

• Hospital cost (will be measured in standardized dollars)

• Resource utilization (will be measured by resource-based relative-value units)

To assess the outcome ...