Clinical trials: Valve Replacement
Congenital Disorders
Ross Aortic Valve Replacement Patients
The Ross procedure has become the surgery of choice for aortic valve replacement in children. This consists of taking a child's own pulmonary valve (the autograft) and replacing the child's diseased aortic valve with the…
- Trial name
- NCT00267995
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Children's Healthcare of Atlanta
Mitral Regurgitation, Mitral Valve Disease
Munich Transcatheter Mitral Valve Safety and Effectiveness
The Munich Trascatheter Mitral Valve System is intended for beating heart, mitral valve replacement in patients with a diseased, damaged, or malfunctioning mitral valve.
- Trial name
- MUSE (NCT05871983)
- Testing
- MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM
- Where
- 10 sites in Argentina, Brazil and 1 more
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- P+F Products + Features GmbH
Aortic Valve Stenosis
5 Year Observation of Patients With PORTICO Valves
The purpose of this clinical investigation is to further assess the performance and safety profile of the commercially-available Portico™ TAVI System in patients with severe symptomatic aortic stenosis.
- Trial name
- PORTICO-1 (NCT01802788)
- Testing
- St Jude Medical Portico replacement aortic valve, Transcatheter Aortic Valve Implant
- Where
- 60 sites in Australia, Belgium and 11 more
- Volunteers
- 1,032 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis
Aortic Stenosis Associated Left Ventricular Remodeling - An Investigation of Genetic and Gender Specific Differences in 170 Patients Undergoing Aortic Valve Replacement Surgery
The goal of this study is to investigate the genetic and gender specific differences, in patients with low flow low gradient aortic stenosis and high flow high gradient aortic stenosis.
- Trial name
- SALVAGE (NCT05696145)
- Volunteers
- 170 people
- Sponsor
- Lisa Gundestrup
Postoperative Kidney Injury
Use of 6% Hydroxyethylstarch (130/0.4) in Cardiac Surgical Patients
The purpose of this study is to evaluate the safety of a standard volume replacement called HES 130/0.4 (Voluven) during surgery on recovery.
- Trial name
- SHARP (NCT02192502)
- Testing
- human albumin 5%, HES 130/0.4 (Voluven)
- Where
- United States
- Volunteers
- 149 people
- Sponsor
- The Cleveland Clinic
Aortic Stenosis, Aortic Stenosis With Bicuspid Valve
HANGZHOU Solution in Bicuspid AS Undergoing TAVR
To compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic…
- Trial name
- NCT04722796
- Testing
- TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution), TAVR with Venus A plus using annular sizing and THV implantation technique
- Where
- 18 sites in China
- Volunteers
- 508 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Aortic Valve Stenosis, Postoperative Complications
Comparing Suture vs. Combined Closure Strategies for Large Blood Vessel Access in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
The goal of this clinical trial is to compare two strategies for closing the main artery access site in adult patients undergoing transcatheter aortic valve implantation (TAVI) through a blood vessel in the leg (transfemoral…
- Conditions
- Aortic Valve Stenosis, Postoperative Complications, Vascular System Injuries, Hemorrhage
- Trial name
- SEAL-TAVI (NCT07743697)
- Testing
- Single Suture-Based Vascular Closure Device, Extravascular Collagen Plug-Based Closure Device
- Where
- Switzerland
- Volunteers
- 705 people
- Sponsor
- University Hospital, Basel, Switzerland
Aortic Valve Stenosis
Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Early Feasibility Trial
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.
- Trial name
- RADIANT (NCT02799823)
- Testing
- HLT Transcatheter Aortic Valve System
- Where
- 5 sites in United States
- Volunteers
- 11 people
- Sponsor
- HLT Inc.
Aortic Stenosis, Anxiety
10-year Follow-up After Aortic Valve Replacement Surgery
There is a lack of data on patients self-reported outcomes (PROMs) on health-related quality of life (HRQoL)and symptoms on anxiety and depression 10 years after Surgical After Aortic Valve Replacement (SAVR), and patient…
- Conditions
- Aortic Stenosis, Anxiety, Depressive Symptoms, Quality of Life
- Trial name
- AVR-10year (NCT06255691)
- Volunteers
- 282 people
- Sponsor
- Oslo University Hospital
TAVI(Transcatheter Aortic Valve Implantation)
Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI)
The TAVIPILOT Software by Caranx Medical is an advanced intraoperative assistance tool designed to enhance the accuracy of transcatheter aortic valve positioning during TAVI.
- Trial name
- SAITO 1B (NCT07100340)
- Testing
- TAVR using a guidance software
- Volunteers
- 10 people
- Sponsor
- Caranx Medical
Aneurysm Aortic Root, Aortic Valve, Bicuspid
Aortic Valve Dynamics During Exercise After Valve Sparing Root Replacement Surgery
Aortic valve sparing operations are applied in patients with a non-calcified tricuspid or bicuspid aortic valve associated with a root aneurysm, in order to preserve the valve, and avoid new aortic dilatation by stabilizing the…
- Trial name
- NCT04205474
- Testing
- graded bicycle test
- Where
- Belgium
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University Hospital, Ghent
Cardiac Output, High
Mean Systemic Filling Pressure and Heart Performance Predicting Fluid Responsiveness in Aortic Valve Replacement
The purpose of this study is to determine fluid responsiveness in critically ill patients by measuring mean systemic filling pressure on the intensive care unit.
- Trial name
- NCT02778620
- Where
- Netherlands
- Volunteers
- 27 people
- Sponsor
- Catharina Ziekenhuis Eindhoven
Aortic Valve Disease, Aortic Stenosis
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively.
- Trial name
- PERSIST-AVR (NCT02673697)
- Testing
- Perceval valve, other stented biological valve
- Where
- 47 sites in United States, Austria and 10 more
- Volunteers
- 914 people
- Sponsor
- Corcym S.r.l
Left Ventricular Systolic Function
Predictors of Left Ventricular Systolic Function Recovery After Transcatheter Aortic Valve Replacement
Investigate the preprocedural predictors of left ventricular systolic function Recovery after TAVR
- Trial name
- NCT05069168
- Testing
- Echocardiography before and after TAVR
- Where
- Egypt
- Volunteers
- 75 people
- Sponsor
- Assiut University
Aortic Regurgitation Disease, Aortic Valve Calcification
Valvular Assessment of New Generation Aortic Replacement Devices
The VANGUARD study is an open-label, prospective, randomized trial comparing the long-term outcomes of two advanced bioprosthetic aortic valves, Dafodil® and INSPIRIS Resilia®, in patients undergoing aortic valve replacement…
- Conditions
- Aortic Regurgitation Disease, Aortic Valve Calcification, Bicuspid Aortic Valve Disease
- Trial name
- VANGUARD (NCT06688448)
- Testing
- Dafodil prosthesis, Aortic Valve Replacement - Inspires Resilia prosthesis
- Where
- Brazil
- Volunteers
- 200 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Ischemic And Bleeding Risk Assessment After TAVR
Transcatheter aortic valve replacement (TAVR) represents an effective treatment to improve symptoms and prognosis in patients with symptomatic severe aortic stenosis (AS) (1-2).
- Trial name
- FOCUS ONE (NCT06000943)
- Testing
- Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT
- Where
- 12 sites in Belgium, Chile and 3 more
- Volunteers
- 2,500 people
- Sponsor
- Niguarda Hospital
Transcatheter Aortic Valve Replacement
Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR
This study will compare the use of one Perclose device to the usual approach of two devices for pre-closure during Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT06871774
- Testing
- Single Perclose Pro vascular closure device, Dual Perclose vascular closure device
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Wake Forest University Health Sciences
Aortic Stenosis
Impact of Beta-blocker on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement (B-TAVR)
This is a multi-centric, open-label, randomized trial to evaluate the safety and efficacy of temporary discontinuation of beta-blocker treatment in patients undergoing transcatheter aortic valve replacement.
- Trial name
- NCT06472934
- Testing
- Transcatheter aortic valve replacement in the absence of B-blocker treatment, Transcatheter aortic valve replacement
- Where
- 11 sites in Austria, Germany and 1 more
- Volunteers
- 498 people
- Sponsor
- University Hospital, Basel, Switzerland
Aortic Valve Stenosis, Cardiovascular Diseases
The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry
The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis.
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Valve Diseases, Bicuspid
- Trial name
- Bicuspid TAVR (NCT02394184)
- Testing
- transcatheter aortic valve replacement
- Where
- South Korea
- Volunteers
- 102 people
- Sponsor
- Seung-Jung Park
Protamine Dose, Protamine Adverse Reaction
Impact of Protamine Dose Reduction on Platelet Aggregation After Extracorporeal Circulation for Minimally Invasive Aortic Valve Replacement Surgery
Determining the minimum effective dose of protamine after extracorporeal circulation for mini-sternotomy aortic valve replacement surgery.
- Trial name
- NCT06254404
- Testing
- Low dose protamine
- Volunteers
- 50 people
- Sponsor
- University of Liege