Clinical Trials

The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality.

The purpose of this study is to compare ejection hemodynamics in patients with obstructive hypertrophic cardiomyopathy (HCM) before and after septal myectomy.

The purpose of this study is to establish a registry to collect safety and clinical performance post market data related to the procedure and follow-up of the Sorin Group aortic valve devices in accordance with the Instructions for Use (IFU). This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry in accordance with the local applicable regulations.

Our overall goal is to determine whether the AVR improves SDB where present and sleep profiles (including sleepiness symptoms, quality of life and hypoxia).

Bicuspid aortic valve (BAV) disease is the most frequent congenital cardiac malformation, occurring in 0.5-1.2% of the US population. In young adults, it is generally a benign abnormality; but in older adults it is associated with thoracic aortic aneurysm or dissection in 20-30% of those with BAV. BAV is strongly associated with early development of aortic valve calcification or incompetence in >50% of BAV patients, and accounts for ~40% of the >30,000 aortic valve replacements (AVR) performed in the US each year. Yet, we know little of the etiology, cellular events and modifiers of progression of BAV to calcific aortic ...

This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant.

The primary objective of this trial is to test the safety and efficacy of Perceval versus standard sutured stented bioprosthetic aortic valves among the intended trial population.

The purpose of this study is to evaluate and compare operative outcomes of the aortic valve-sparing (AVS) and aortic valve replacement (AVR) surgical interventions in different categories of patients with Marfan syndrome and estimate the predictors of the surgical outcomes.

The purpose of this study is to evaluate the outcomes of surgical Aortic Valvotomy for congenital aortic stenosis.

The goal of this study is to create a comprehensive system of blood and tissue banking of samples from Mayo Clinic Arizona patients with a clinical diagnosis of aortic stenosis who are either undergoing routine care at Mayo Clinic or undergoing aortic valve surgery.  The tissue samples will be used for future research of aortic stenosis at Mayo Clinic and future research at Mayo Clinic to learn about, prevent, or treat other health problems.

The purpose of this study is to determine if participants with an On-X Prosthetic Heart Valve / On-X aortic valve can be maintained safely and effectively on apixaban. Both the On-X aortic valve and apixaban have been approved for use by the US Food and Drug Administration (FDA) but they have not been approved to be used together.  Currently, warfarin is the only approved anticoagulation for patients with mechanical valves.

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 objective of this study is to evaluate the safety and performance of the Trifecta™ GT (Glide Technology) valve through 5 year follow-up in a prospective, multi-center, real-world setting. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.

The purpose of this study is to find if cardiopulmonary exercise testing data will provide any predictive information in evaluating patients with aortic stenosis for severity, symptoms and surgical risk.

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 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 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 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 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.

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 obtain baseline stress and strain of abdominal aortic artery prior to endovascular repair, and to compare the variation in stress and strain of Ovation vs. Cook stent grafts immediately post-operativelythen after 1 month, 3 months, 6 months, and 12 months following endovascular repair.

The purpose of this study is to determine whether patients diagnosed with severe aortic stenosis have a measurable change in heart function as measured by a new technique (3D echocardiographic strain) compared to controls and to determine whether they show a significant improvement in heart function (as measured by 3D strain) during intermediate-term follow up after aortic valve replacement.

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 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 study is to compare echocardiographic between acute and chronic severe AR patients at baseline and after surgical aortic valve replacement.

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

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:

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.

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.

The purpose of this study is to demonstrate the safety and effectiveness of the AVP III as a treatment for clinically significant PVLs following surgical implant of a mechanical or biological heart valve implanted in the aortic or mitral position.

Classical echocardiographic assessment of heart valves is critical in determination of disease severity. However, echocardiography has only limited ability to predict how well an individual patient will do at time of surgery. New echocardiographic technology allows us to measure new, more refined parameters of your heart’s performance. This study is investigating whether these new parameters are better in predicting outcomes.

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 ...

The purpose of this study is to assess operative and postoperative outcomes after aortic valve surgery, evaluate for changes in ascending aorta diameter by comparing pre-operative CT imaging to measurements on follow-up imaging, and examine late outcomes and functional status during the follow-up period with specific focus on mortality, need for re-operation and incidence of aortic dissection.

The study aims to analyze echocardiogram data of women of reproductive age (18-45) with known bicuspid aortic valve disease and determine if pregnancy leads to increased rates of aortic dilation, surgical repair and/or dissection.

The purpose of this study is to test if a reduction of hemoglobin leads to subclinical cardiac dysfunction in patients with known cardiovascular disease.