Clinical trials: Aortic Valve Regurgitation
Functional Mitral Regurgitation
Treatment of Moderate FMR During AVR
Debates exist on the treatment of moderate functional mitral regurgitation (FMR) in patients undergoing aortic valve replacement (AVR) for aortic valve disease.
- Trial name
- NCT05566340
- Testing
- mitral valve repair
- Volunteers
- 154 people
- Sponsor
- Fuwai Yunnan Cardiovascular Hospital
Mitral Valve Regurgitation, Heart Failure
Structural Heart and Valve Network PROSPECTIVE Registry
Background: Treatments for structural heart and valve disease are quickly changing. But treatment could be improved. Researchers want to gather data from people with this disease.
- Conditions
- Mitral Valve Regurgitation, Heart Failure, Heart Valve Disease, Tricuspid Valve Regurgitation
- Trial name
- NCT03928639
- Where
- United States
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Aortic Valve Insufficiency, Regurgitation, Aortic Valve
An Observational, Prospective Evaluation of the Trifecta™ Valve
This trial is designed to confirm the clinical safety and effectiveness of the Trifecta valve by establishing associated adverse event rates, clinical status as indicated by New York Heart Association (NYHA) functional…
- Conditions
- Aortic Valve Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence, Aortic Valve Stenosis
- Trial name
- NCT00727181
- Testing
- Trifecta aortic heart valve
- Where
- 4 sites in France, Germany and 1 more
- Volunteers
- 120 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis, Aortic Valve Insufficiency
The Italian Society of Invasive Cardiology Registry on Percutaneous Aortic Valve
The Italian Society of Invasive Cardiology Registry on Percutaneous Aortic Valve is a prospective Italian registry including several centers performing TAVI, collecting baseline, procedural and outcome data.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency, Transcatheter Aortic Valve Replacement
- Trial name
- NCT02713932
- Testing
- Transcatheter aortic valve implantation
- Where
- Italy
- Volunteers
- 2,000 people
- Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Aortic Valve Stenosis, Mitral Regurgitation
Addressing Under-treatment and Health Equity in AS and MR Using an Integrated EHR Platform
This multi-center, prospective, cluster-randomized controlled trial will evaluate Tempus Next automated notifications as an intervention to support identification and evaluation of patients possibly indicated for Valve…
- Trial name
- ALERT (NCT06099665)
- Testing
- Automated alert
- Where
- 6 sites in United States
- Volunteers
- 2,118 people
- Sponsor
- Tempus AI
Mitral Regurgitation, Aortic Regurgitation
Comparison Study of Echocardiography and Cardiovascular Magnetic Resonance Imaging in the Assessment of Mitral and Aortic Regurgitation
The primary treatment for patients determined to have severe aortic or mitral regurgitation is surgical repair or replacement their valves.
- Trial name
- NCT04038879
- Testing
- MRI
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Atlantic Health System
Aortic Valve Stenosis, Structural Valve Deterioration
Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
The VIVALL-2 study is a randomized trial to compare the self-expandable supra-annular Allegra and the balloon-expandable intra-annular Edwards transcatheter valve systems in patients with degenerated biological aortic surgical…
- Trial name
- NCT06049654
- Testing
- NVT ALLEGRA TAVI System TF, EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM
- Where
- 12 sites in Italy, Spain and 1 more
- Volunteers
- 104 people
- Sponsor
- Fundación EPIC
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.
Aortic Valve Stenosis, Aortic Valve Insufficiency
Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population
This is a prospective, observational, single-arm, multi-center registry of patients undergoing bioprosthetic aortic valve replacement with the Avalus valve.
- Trial name
- Avalus (NCT05572710)
- Where
- 19 sites in Belgium, Denmark and 6 more
- Volunteers
- 1,000 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Aortic Valve Stenosis, Aortic Valve Regurgitation
TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease
To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).
- Conditions
- Aortic Valve Stenosis, Aortic Valve Regurgitation, Aortic Valve Stenosis With Insufficiency, Constriction, Pathologic
- Trial name
- TAVIS (NCT05536310)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 3 sites in Germany
- Volunteers
- 24 people
- Sponsor
- JenaValve Technology, Inc.
Heart Valve Diseases, Aortic Valve Stenosis
CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.
The goal of this interventional, single-center study is to demonstrate if there is a change in the coronary ostia height after surgical aortic valve replacement and if it depends on the type of prosthesis or surgical technique…
- Conditions
- Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency, Regurgitation, Aortic
- Trial name
- CORONATE (NCT05714293)
- Testing
- CT scan with contrast medium
- Where
- Italy
- Volunteers
- 90 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Valvular Heart Disease Patients, Aortic Stenosis
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Heart valve disease and weakened heart muscle (left ventricular systolic dysfunction) are common in older adults and often go undetected until serious complications such as heart failure develop.
- Conditions
- Valvular Heart Disease Patients, Aortic Stenosis, Mitral Regurgitation, Left Ventricular Diastolic Dysfunction
- Trial name
- IMPROVE (NCT07756398)
- Testing
- Kosmos Torso-One AI-guided Point-of-Care Ultrasound (EchoNous, Inc.)
- Where
- 2 sites in United States
- Volunteers
- 1,088 people
- Sponsor
- University of Texas Southwestern Medical Center
Aortic Stenosis, Aortic Insufficiency
JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation
The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.
- Conditions
- Aortic Stenosis, Aortic Insufficiency, Aortic Regurgitation
- Trial name
- JUPITER (NCT01598844)
- Testing
- Transcatheter aortic valve replacement
- Where
- 15 sites in Germany, Netherlands and 2 more
- Volunteers
- 210 people
- Sponsor
- JenaValve Technology, Inc.
Aortic Valve Regurgitation
CT Scan Sizing for Perceval Sutureless Valve
The Perceval sutureless aortic bioprosthesis is a bovine pericardium valve mounted in a nitinol stent that can be compressed and positioned in a valve delivery system.
- Trial name
- PERCEVAL (NCT05799573)
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Maria Cecilia Hospital
Aortic Regurgitation
Velocity Vector Imaging in Patients With Moderate-to-Severe Aortic Regurgitation
Velocity Vector Imaging may provide reliable and detailed information on left ventricular segmental function in asymptomatic patients with moderate-to severe AR.
- Trial name
- NCT00624884
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Florence Nightingale Hospital, Istanbul
Stenosis, Regurgitation, Aortic
Dokimos Plus Aortic Valve Implant in 80 Patients Diagnosed With a Heart Valve Disease and Requiring Valve Replacement
This study intends to reinforce the current clinical information regarding safety and efficacy of the Dokimos Plus aortic valve prosthesis in patients in whom an aortic valve replacement with a bioprosthesis has been indicated.
- Trial name
- NCT04370041
- Testing
- Dokimos Plus aortic valve
- Where
- 3 sites in Spain
- Volunteers
- 80 people
- Sponsor
- Swan Medical S. L.
Paravalvular Aortic Regurgitation
PARADIGM: Amplatzer Valvular Plug for PVL Closure
The Paradigm study is a prospective, multicenter, single arm study to demonstrate the safety and effectiveness of the Amplatzer Valvular Plug III (AVP III) as a treatment for clinically significant PVLs following surgical implant…
- Trial name
- PARADIGM (NCT04489823)
- Testing
- AVP III
- Where
- 24 sites in United States, Canada and 5 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Disease, Aortic Aneurysm
Aortopathy Relationship To Imagery and Kinocardiography Features (ARTIK)
Kinocardiography (KCG) is a portable measurement technique developed to estimate cardiac mechanical performance by studying the vibrations produced by myocardial contraction during each heartbeat and transmitted to the body…
- Trial name
- ARTIK (NCT06286358)
- Testing
- Kinocardiography
- Where
- Belgium
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Université Libre de Bruxelles
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 Valve Stenosis, Aortic Valve Stenosis With Insufficiency
Perceval S Aortic Heart Valve Study- North America
To demonstrate the safety and effectiveness of the Perceval S heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
- Trial name
- NCT01810679
- Testing
- Perceval S Aortic Heart Valve
- Where
- 21 sites in United States
- Volunteers
- 355 people
- Sponsor
- Sorin Group USA, Inc.