Clinical trials: Aortic Valve Stenosis
Aortic Stenosis, Aortic Regurgitation
Rivaroxaban or Aspirin for Biological Aortic Prosthesis
Aortic valve replacement with a biological prosthesis is the most common valve surgery performed with about 1000 operations performed in Denmark each year.
- Conditions
- Aortic Stenosis, Aortic Regurgitation, Thrombosis
- Trial name
- NCT02974920
- Testing
- Rivaroxaban 10 MG, Aspirin
- Where
- 4 sites in Denmark
- Volunteers
- 1,000 people
- Sponsor
- Christian Torp-Pedersen
Aortic Valve Stenosis
Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation
The aim of the study is to evaluate the clinical efficacy of 2 different vascular closure device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI).
- Trial name
- CHOICE-CLOSURE (NCT04459208)
- Testing
- Manta, ProGlide
- Where
- Germany
- Volunteers
- 516 people
- Sponsor
- Helios Health Institute GmbH
Pacemaker, TAVI
TAVI PACER: A Two-step Risk Score for Prediction of Permanent Pacemaker Implantation After TAVI.
The need for permanent pacemaker implantation (PPMI) remains one of the most frequent complications after transcatheter aortic valve implantation (TAVI).
- Conditions
- Pacemaker, TAVI, Risk Score
- Trial name
- TAVI PACER (NCT06542380)
- Testing
- TAVI, pacemaker
- Where
- Germany
- Volunteers
- 1,000 people
- Sponsor
- German Heart Institute
Alternative Surgical Treatment for Aortic Valve Disease
TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium
Reconstruction of the aortic valve using the tri-leaflet repair technique is non-inferior with regard to effective orifice area (EOA) to surgical aortic valve replacement (SAVR) with a biological prosthesis (St.
- Trial name
- TriRec (NCT03600662)
- Testing
- TriRec, Aortic valve replacement
- Where
- Germany
- Volunteers
- 128 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Aortic Stenosis
18F-NaF Uptake and Aortic Stenosis Progression
This study aims to evaluate whether baseline 18F-sodium fluoride uptake activity at aortic valve could predict aortic stenosis progression in moderate aortic stenosis.
- Trial name
- NCT02740088
- Testing
- Imaging test: 18F-NaF PET/CT
- Volunteers
- 28 people
- Sponsor
- Seoul St. Mary's Hospital
Aortic Stenosis, Multi Vessel Coronary Artery Disease
The TransCatheter Valve and Vessels Trial
The trial objective is to investigate whether Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention (PCI) and TransCatheter Aortic Valve Implantation (TAVI) strategy for treatment of multivessel disease and…
- Conditions
- Aortic Stenosis, Multi Vessel Coronary Artery Disease, TAVI, CABG
- Trial name
- TCW (NCT03424941)
- Testing
- FFR-guided PCI and TAVI, CABG and SAVR
- Where
- 20 sites in Austria, Denmark and 8 more
- Volunteers
- 172 people
- Sponsor
- Maatschap Cardiologie Zwolle
Aortic Stenosis, Aortic Regurgitation
Transcatheter Aortic Valve Replacement With Extracorporeal Life System Support
Transcatheter aortic valve replacement (TAVR) has a high risk and a high mortality rate in the treatment of aortic stenosis/regurgitation patients with cardiac insufficiency.
- Conditions
- Aortic Stenosis, Aortic Regurgitation, Heart Failure With Reduced Ejection Fraction
- Trial name
- NCT04160624
- Testing
- transcatheter aortic valve replacement
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Xijing Hospital
Patients With an Indication for an Echocardiographic Examination With Suspicion of Valcular Heart Disease
Point-of-Care Echocardiography in Patients With Known or Suspected Aortic Stenosis
This is a prospective clinical trial intended to capture echocardiographic images in patients clinically indicated for an echocardiographic examination using an additional Point of Care Ultrasound device .
- Trial name
- POC (NCT06717373)
- Testing
- AutoAS
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Caption Health, Inc.
Platelet Function Tests, Predictive Value of Tests
Risk Stratification Post TAVI Using TEG
Transcatheter aortic valve implantation (TAVI) has become the standard of care in elderly patients at increased risk for surgical aortic valve replacement . However, the optimal antithrombotic strategy post TAVI is still unclear.
- Conditions
- Platelet Function Tests, Predictive Value of Tests, Thrombelastography, Cardiovascular Diseases
- Trial name
- RISTRATAVI (NCT03649594)
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Torben Pottgiesser
AORTIC VALVE DISEASES, Mitral Valve Disease
Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve
The goal of this clinical trial is to explore the early feasibility, initial safety, and efficacy of surgical implantation of a polymer prosthetic heart valve in patients requiring either mitral valve replacement or aortic valve…
- Conditions
- AORTIC VALVE DISEASES, Mitral Valve Disease, Aortic Stenosis, Aortic Regurgitation
- Trial name
- POLYVALVE-FIH (NCT07097740)
- Testing
- Polymer Prosthetic Heart Valve
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Mitrassist Lifesciences Limited Co., Ltd.
Aortic Aneurysm, Iliac Aneurysm
Comparison of Aorto-iliac Endovascular Interventions With and Without the EndoNaut Workstation
The aim of this retrospective, multicenter study is to demonstrate that the use of EndoNaut for aortoiliac endovascular procedures has a clinical impact for the patient (reduction in irradiation and the volume of contrast…
- Conditions
- Aortic Aneurysm, Iliac Aneurysm, Stenoses, Aortic, Iliac Artery Stenosis
- Trial name
- COM-ENDO (NCT04714268)
- Testing
- Aorto-iliac endovascular procedure
- Where
- France
- Volunteers
- 150 people
- Sponsor
- Therenva
Aortic Valve Stenosis
Protamine Sulfate During Transcatheter Aortic Valve Implantation
Transcatheter aortic valve implantation (TAVI) is a new, rapidly emerging standard of care in inoperable and high-risk patients with severe, symptomatic aortic stenosis.
- Trial name
- PS TAVI (NCT02974660)
- Testing
- Protamine sulfate, 0.9% NaCl
- Where
- Poland
- Volunteers
- 100 people
- Sponsor
- Medical University of Warsaw
Aortic Stenosis, Transcatheter Aortic Valve Implantation
Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
The goal of the NEO2 BAV registry is to investigate the safety, effectiveness, and clinical performance of TAVI using the ACURATE neo2 valve in patients with severe BAV stenosis.
- Conditions
- Aortic Stenosis, Transcatheter Aortic Valve Implantation, Bicuspid Aortic Valve, Transcatheter Aortic Valve Replacement
- Trial name
- Neo2BAV (NCT06212050)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- 3 sites in Germany, Ireland and 1 more
- Volunteers
- 200 people
- Sponsor
- National University of Ireland, Galway, Ireland
Aortic Valve Stenosis
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.
- Trial name
- NCT04639258
- Testing
- Medtronic Evolut™ PRO+ System
- Where
- 8 sites in United States, Australia and 3 more
- Volunteers
- 11 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Stenosis
Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation
A single-center, investigator-initiated, single arm interventional study in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) in the Erasmus Medical Center in Rotterdam (NL).
- Trial name
- REDOX-TAVI (NCT04171726)
- Testing
- Edoxaban
- Where
- Netherlands
- Volunteers
- 100 people
- Sponsor
- Erasmus Medical Center
Aortic Stenosis, Heart Failure
High-Sensitivity Troponin T Plasma Levels in Patients With Aortic Stenosis (Tyrolean Aortic Stenosis Study-2)
TASS-2 (Tyrolean Aortic Stenosis Study-2) aims to characterize the clinical value of minimally elevated troponin T plasma levels both in patients with asymptomatic and symtomatic aortic stenosis.
- Conditions
- Aortic Stenosis, Heart Failure, Syncope, Angina Pectoris
- Trial name
- TASS-2 (NCT02448485)
- Testing
- Aortic Valve Intervention (surgical or transcatheter)
- Where
- Austria
- Volunteers
- 10,000 people
- Sponsor
- Medical University Innsbruck
Hypertrophic Cardiomyopathy
Family Studies of Inherited Heart Disease
Hypertrophic cardiomyopathy (HCM) is a genetically inherited heart disease. It causes thickening of heart muscle, especially the chamber responsible for pumping blood out of the heart, the left ventricle.
- Trial name
- NCT00001225
- Where
- United States
- Volunteers
- 5,880 people, healthy volunteers welcome
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Aortic Valve Stenosis, Bicuspid Cardiac Valve
Addition of Computer Simulations to Minimize Adverse Events After Transcatheter Aortic Valve Implantation
The objective is to assess the influence of FEops HEARTguide on overall device success in TAVI patients with challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B).
- Trial name
- PRECISE_TAVI (NCT04473443)
- Testing
- FEops HEARTguideTM
- Where
- Netherlands
- Volunteers
- 200 people
- Sponsor
- Erasmus Medical Center
Aortic Stenosis
Self-Centering Guide Catheter Feasibility Study
An evaluation of the feasibility of using the Self-Centering Guide Catheter to deliver a guide wire across a stenotic native aortic valve into the left ventricle.
- Trial name
- NCT02639494
- Testing
- Self-Centering Guide Catheter
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Disease, Transcatheter Aortic Valve Replacement
The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures
TAVR patients exhibiting post-procedural residual AR had higher mortality and hospitalization rates due to heart failure, with the extent of this association increasing proportionally to the severity of the regurgitation.
- Conditions
- Aortic Valve Disease, Transcatheter Aortic Valve Replacement, Aortic Valve Stenosis, Hemodynamic Measurement
- Trial name
- SAVVY (NCT05082337)
- Testing
- SAVVY guidewire
- Where
- 2 sites in Canada
- Volunteers
- 20 people
- Sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
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