Clinical trials: Valve Replacement
Aortic Stenosis, Aortic Insufficiency
Freedom SOLO Stentless Heart Valve Study
The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the Freedom SOLO heart valve.
- Trial name
- SOLO (NCT01115907)
- Testing
- Freedom SOLO Stentless Heart Valve
- Where
- 15 sites in United States, Canada
- Volunteers
- 251 people
- Sponsor
- Sorin Group USA, Inc.
Severe Symptomatic Aortic Stenosis
Alternative Access Approaches for Transcatheter Aortic Valve Replace (TAVR) in Inoperable Patients With Aortic Stenosis
Investigational study of Edwards Lifesciences, LLC's "Edwards SAPIEN Transcatheter Heart Valve" for non-femoral delivery, (or alternative access deliver) in patients with severe symptomatic native aortic valve stenosis who have…
- Trial name
- Inop AA (NCT01787084)
- Testing
- Edwards SAPIEN Transcatheter Heart Valve
- Volunteers
- 8 people
- Sponsor
- The Society of Thoracic Surgeons
Aortic Valve Disease, Myocardial Ischemia
Remote Ischemic Preconditioning in Patients Undergoing Isolated Aortic Valve Replacement Surgery
The goal is to investigate the efficacy, safety and possible neuro- and cardioprotective effects of remote ischemic preconditioning (RIPC) in adult cardiac patients undergoing isolated aortic valve replacement surgery with a…
- Trial name
- NCT02694016
- Testing
- Remote ischemic preconditioning
- Where
- Finland
- Volunteers
- 4 people
- Sponsor
- Oulu University Hospital
Aortic Valve Stenosis
A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System
The purpose of this postmarket Registry is to assess the standard of care and clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System used in clinical routine according to the approved commercial…
- Trial name
- DISCOVER (NCT01845285)
- Testing
- Aortic Valve Replacement
- Where
- 2 sites in Germany, Italy
- Volunteers
- 1,000 people
- Sponsor
- Direct Flow Medical, Inc.
MV(Mitral Valve) Repair
Explore the Efficacy and Safety of edoxabaN in Patients After Heart Valve Repair or Bioprosthetic vaLve Replacement (ENAVLE Trial)
1. objectives: The primary aim of ENAVLE is to explore the efficacy of edoxaban in patients with post mitral valve repair or bioprosthetic valve implantation 2.
- Trial name
- NCT03244319
- Testing
- Edoxaban, Warfarin, parenteral anti-coagulant (UFH)
- Where
- South Korea
- Volunteers
- 220 people
- Sponsor
- Yonsei University
Severe Aortic Valve Stenosis
A Clinical Study Using FAPI-PET Imaging to Assess the Postoperative Effects of TAVI in Patients With Aortic Stenosis
This study will include patients with severe degenerative aortic stenosis (AS) who meet the inclusion criteria and voluntarily participate (planned to undergo TAVI), as well as patients with aortic stenosis who have not undergone…
- Trial name
- NCT07335900
- Testing
- Transcatheter Aortic Valve Implantation, Optimal medication treatment
- Where
- China
- Volunteers
- 25 people
- Sponsor
- RenJi Hospital
Bicuspid Aortic Valve, Aortic Valve Stenosis
Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.
The goal of this prospective, non-randomized, single-center, observational study is to assess whether there is a progressive dilation of ascending aorta after surgical or transcatheter aortic valve replacement (TAVR) in patients…
- Conditions
- Bicuspid Aortic Valve, Aortic Valve Stenosis, Aortic Aneurysm, Heart Diseases
- Trial name
- ARDITAV (NCT05708118)
- Testing
- Echocardiographic assessment., Computed-tomography assessment
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Infective Endocarditis (IE), Heart Valve Disease
The Study Tests if Preoperative Dental Screening is Superior to no Preoperative Dental Screening in Improving the Outcome of Patients Undergoing Surgical Cardiac Valve Replacement or Transcatheter Cardiac Valve Implantation.
This randomized, multicenter, open-label trial evaluates whether preoperative dental screening improves outcomes in patients undergoing surgical or transcatheter cardiac valve intervention.
- Trial name
- SMILE (NCT07511673)
- Testing
- Preoperative dental screening, No preoperative dental screening
- Where
- 5 sites in Sweden
- Volunteers
- 1,300 people
- Sponsor
- Region Skane
Atrial Fibrillation, Deep Venous Thrombosis
Modeling Genotype and Other Factors to Enhance the Safety of Coumadin Prescribing
The study goal is to conduct a randomized controlled trial to compare safety and accuracy of dosing based on clinical information including the clinical reason for your taking coumadin, your age, gender, your body surface area…
- Conditions
- Atrial Fibrillation, Deep Venous Thrombosis, Heart Valve Replacement, Pulmonary Embolism
- Trial name
- NCT00484640
- Testing
- Coumadin
- Where
- 2 sites in United States
- Volunteers
- 260 people
- Sponsor
- Agency for Healthcare Research and Quality (AHRQ)
Aortic Valve Stenosis
Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis.
Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with severe symptomatic aortic stenosis and at increased risk for surgical aortic valve replacement (SAVR).
- Trial name
- SCOPE I (NCT03011346)
- Testing
- Symetis ACURATE neo/TF transfemoral TAVI system, Edwards Sapien 3 Transcatheter Heart Valve
- Where
- 20 sites in Germany, Netherlands and 2 more
- Volunteers
- 739 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Aortic Valve Stenosis
Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study
The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are…
- Trial name
- NCT05864456
- Testing
- Prizvalve Pro™ transcatheter aortic valve system
- Where
- China
- Volunteers
- 73 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Aortic Regurgitation, Aortic Valve Insufficiency
The JenaValve ALIGN-AR LVAD Registry
To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically…
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
- Trial name
- JENA-VAD (NCT06594705)
- Testing
- JenaValve Trilogy Heart Valve System
- Where
- 14 sites in United States
- Volunteers
- 50 people
- Sponsor
- JenaValve Technology, Inc.
Aortic Valve Disease, Surgery--Complications
Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)
There is considerable morbidity and mortality associated with cardiac surgery. Currently little effort is made to quantify how well the immune system of an individual can cope with inflammation or infection to which they are…
- Conditions
- Aortic Valve Disease, Surgery--Complications, Immune System Disorder
- Trial name
- Measure (NCT04430972)
- Testing
- Aortic valve replacement
- Where
- United Kingdom
- Volunteers
- 150 people
- Sponsor
- Barts & The London NHS Trust
Cardiac Rehabilitation
Home-based Mobile Guided Exercise-based Cardiac Rehabilitation Among Patients Undergoing TAVR
A two-parallel, evaluator-blind, single-center, randomized controlled trial was designed to assess the effectiveness of a home-based mobile guided exercise-based cardiac rehabilitation among patients undergoing Transcatheter…
- Trial name
- REHAB-TAVR (NCT05989594)
- Testing
- Home-based mobile guided exercise-based cardiac rehabilitation, Routine Care
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Shanghai Zhongshan Hospital
Transcatheter Aortic Valve Replacement
Prognostic Factors in NOP-LBBB After TAVI
The goal of this observational study is to find prognostic factors in patients with a new-onset persistent left bundle branch block (NOP-LBBB) after transcatheter aortic valve implantation (TAVI).
- Trial name
- ProgNOP-LBBB (NCT05654792)
- Testing
- Transcatheter aortic valve implantation
- Volunteers
- 230 people
- Sponsor
- Central Hospital, Nancy, France
Aortic Valve Stenosis, Aortic Valve Insufficiency
Pilot Trial: Comparison of Flow Patterns
The purpose of this study is to determine why sutureless aortic bioprostheses apparently offer better haemodynamic properties compared to sewed-in aortic bioprostheses in patients who underwent aortic valve replacement.
- Trial name
- NCT02288871
- Testing
- Cardiac CT-scan
- Where
- Austria
- Volunteers
- 20 people
- Sponsor
- Medical University of Vienna
Aortic Valve Stenosis, Diastolic Dysfunction
Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis
The purpose of this study is to examine the impact of early surgery in patients with asymptomatic severe aortic valve stenosis with signs of subclinical LV dysfunction despite preserved LVEF, with a watchfull waiting approach.
- Trial name
- DANAVR (NCT03972644)
- Testing
- Aortic valve replacement
- Where
- Denmark
- Volunteers
- 1,700 people
- Sponsor
- Odense University Hospital
Aortic Stenosis
The Role of Myocardial Fibrosis in Patients With Aortic Stenosis
Aortic stenosis is the most common adult valvular heart disease in the western world. Heart failure and sudden cardiac death are complications associated with aortic stenosis.
- Trial name
- NCT01755936
- Testing
- Cardiac Magnetic Resonance Imaging, Echocardiography, 72 hour Holter Monitor
- Where
- United Kingdom
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- University of Edinburgh
Aortic Stenosis
Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
Post-market registry aimed at further evaluating the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in patients with severe aortic stenosis treated with the…
- Trial name
- SAVI TF (NCT02306226)
- Volunteers
- 1,000 people
- Sponsor
- Symetis SA
Right Heart Failure, Right Ventricular Dysfunction
PRediction of Early PostoperAtive Right vEntricular Failure in Mitral Valve Replacement/Repair Patients
The PREPARE-MVR (PRediction of Early PostoperAtive Right vEntricular failure in Mitral Valve Replacement/Repair patients) Study aims to evaluate those preoperative factors which can predict the early postoperative right…
- Conditions
- Right Heart Failure, Right Ventricular Dysfunction, Right Ventricular Failure, Mitral Valve Disease
- Trial name
- PREPARE-MVR (NCT03438825)
- Testing
- Mitral valve replacement/repair
- Where
- Hungary
- Volunteers
- 72 people
- Sponsor
- Semmelweis University Heart and Vascular Center