Clinical trials: Aortic Regurgitation
Aortic Valve Regurgitation
Early Aortic vaLve surgEry Versus wAtchful waitiNg Strategy in Severe Asymptomatic aOrtic reguRgitation
The optimal timing of surgical intervention in asymptomatic patients with severe aortic regurgitation remains controversial. As per cardiac magnetic resonance assessment, early surgical treatment will be compared with…
- Trial name
- ELEANOR (NCT05438862)
- Testing
- State of art aortic valve surgery
- Where
- 8 sites in Belgium, Czechia and 1 more
- Volunteers
- 217 people
- Sponsor
- Na Homolce Hospital
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Protocoled Quantitative Assessment of Aortic Regurgitation Using Videodensitometry in a Multicontinental Trial in Rotterdam, Montreal, Yamaguchi, Segeberg, Amsterdam.
The ASSESS-REGURGE is a multicenter, multicontinental registry on protocoled aortographic image acquisition after implantation of a transcatheter aortic valve.
- Trial name
- ASSESS-REGURGE (NCT03644784)
- Testing
- Standardized protocol for assessing aortic regurgitation using videodensitometry
- Where
- 6 sites in Canada, Germany and 3 more
- Volunteers
- 354 people
- Sponsor
- Imperial College London
Aortic Valve Stenosis, Aortic Valve Regurgitation
Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR
Data on valve performance following ViV-TAVR has usually been obtained with the use of Doppler-echocardiography. However, some reports have shown significant discordances in the evaluation of mean transvalvular gradient between…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Regurgitation, Prosthesis Failure
- Trial name
- ECHOCATH (NCT05459233)
- Testing
- Doppler-echocardiography, Invasive hemodynamic measurements
- Where
- 7 sites in United States, Canada
- Volunteers
- 310 people
- Sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Valvular Heart Disease
The Bronx-Valve Registry
The Bronx-Valve Registry is designed to collect and assess data on all patients with valvular diseases referred to Montefiore Medical Center for echocardiographic exams.
- Trial name
- NCT05453526
- Where
- United States
- Volunteers
- 330,570 people
- Sponsor
- Montefiore Medical Center
Aortic Stenosis
PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry
The purpose of this post-market registry is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™ Transferral Delivery System, when used as per IFU.
- Trial name
- PROGRESS (NCT02987894)
- Testing
- ACURATE neo™ Aortic Bioprosthesis
- Where
- 23 sites in Canada, Germany and 2 more
- Volunteers
- 500 people
- Sponsor
- Symetis SA
Aortic Valve Insufficiency, Aortic Aneurysm
HAART Annuloplasty Device Valve Repair Registry
Multicenter US registry study to assess procedure success and long-term (10-year) performance of the HAART 200 and HAART 300 Aortic Annuloplasty Devices when used during aortic valve repair in a routine cardiovascular practice…
- Trial name
- NCT04035356
- Testing
- Aortic valve repair
- Where
- 5 sites in United States
- Volunteers
- 183 people
- Sponsor
- Biostable Science & Engineering
Valve Disease, Aortic, Mitral Regurgitation (MR)
DELINEATE-Prospective
Heart disease is the leading cause of death in the United States, and echocardiography (or "echo") is the most common way doctors look at the heart.
- Conditions
- Valve Disease, Aortic, Mitral Regurgitation (MR), Aortic Stenosis, Valvular Heart Disease
- Trial name
- DELINEATE (NCT07197736)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
Paravalvular Aortic Regurgitation, Paravalvular Mitral Regurgitation
Transcatheter Para-Valvular Leak Closures
Despite improvements in available techniques and prostheses, the long-term evolution of patients after transcatheter paravalvular leak closure remains poorly understood.
- Conditions
- Paravalvular Aortic Regurgitation, Paravalvular Mitral Regurgitation, Cardiac Valve Disease, Cardiac Catheterization
- Trial name
- FFPP1 (NCT05117359)
- Testing
- transcatheter paravalvular leak closure
- Volunteers
- 366 people
- Sponsor
- Centre Chirurgical Marie Lannelongue
Aortic Regurgitation, Mitral Regurgitation
LOng-Term Fate of Moderate Aortic Regurgitation Left Untreated at the Time of Mitral Valve Surgery
Multivalvular heart disease is a highly prevalent clinical condition that comprises 14.6% of the patients undergoing valvular surgery.
- Trial name
- NCT05774795
- Testing
- Mitral valve surgery, Aortic valve surgery
- Where
- Italy
- Volunteers
- 183 people
- Sponsor
- Michele De Bonis
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 Regurgitation, Mitral Valve Regurgitation
Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation
Investigators assume that surgical correction approach to functional mitral regurgitation during intervention for chronic aortic regurgitation in patients with severe enlargement of the left heart chambers influences reverse…
- Conditions
- Aortic Valve Regurgitation, Mitral Valve Regurgitation, Left Ventricle Dilated, Left Atrium Dilated
- Trial name
- ORMIX (NCT06805253)
- Testing
- Not applicable - observational study
- Where
- 2 sites in Russia
- Volunteers
- 120 people
- Sponsor
- Petrovsky National Research Centre of Surgery
Aortic Regurgitation, Transcatheter Aortic Valve Replacement
TAVR for Aortic Regurgitation Under TEE Guidance
Under contemporary practice, transcatheter aortic valve replacement (TAVR) is typically performed with fluoroscopic visualization and repeated injections of iodinated contrast.
- Trial name
- NCT07453849
- Testing
- TEE guided TAVR
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Aortic Regurgitation
3-Dimensional Simulation Guided Transcatheter Aortic Valve Replacement in Aortic Regurgitation(DIGITAL)
This study will evaluate the safety and efficacy of postmarket bioprosthetic aortic valve in patients with severe aortic regurgitation undergoing transapical transcatheter aortic valve replacement based on 3D simulation…
- Trial name
- DIGITAL (NCT07398911)
- Testing
- 3D simulation technique
- Where
- China
- Volunteers
- 354 people
- Sponsor
- Xijing Hospital
Bicuspid Aortic Valve (BAV)
A Study of Chinese Congenital Bicuspid Aortic Valve
Pervious studies indicated that the prevalence of bicuspid aortic valve（BAV） might be higher in China. There is a familial predisposition to the development of BAV.
- Trial name
- NCT06802016
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Ruijin Hospital
Aortic Valve Disease
Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation
Prospective, multicenter, randomized trial.
- Trial name
- SEASON-AR (NCT04864145)
- Testing
- Transcatheter Aortic Valve Implantation, Medical therapy
- Where
- China
- Volunteers
- 210 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Aortic Regurgitation
Performance of Currently Available traNscaTHEter Aortic Valve Platforms in Inoperable Patients With Pure Aortic regurgitatiON of a Native Valve. The PANTHEON International Project.
To investigate the performance of currently available THVs in terms of safety and efficacy To evaluate potential predictors of THV embolization or migration (TVEM) To assess the impact of TVEM on prognosis
- Trial name
- PANTHEON (NCT05319171)
- Testing
- TAVR
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- IRCCS Policlinico S. Donato
Aortic Regurgitation
Accuracy of Left Subclavian Regurgitation Evaluated by Ultrasound Doppler and 4D Flow MRI
Aortic insufficiency (IA) is defined as an abnormal regurgitation of blood from the aorta to the left ventricle in diastole, due to a lack of tightness of the aortic valves.
- Trial name
- SUBCLAR (NCT03549091)
- Testing
- transthoracic echocardiography, Cardiovascular Magnetic Resonance Imaging
- Where
- France
- Volunteers
- 70 people
- Sponsor
- Fondation Hôpital Saint-Joseph
Aortic Valve Insufficiency
Evaluation of ARi With OpSens SavvyWire
The goal of this observational study is to establish the degree of agreement to Aortic Regurgitation (AR) severity during aortic valve intervention between the Aortic Regurgitation Index (ARi) measured by the Opsens SavvyWire…
- Trial name
- ARi (NCT06295068)
- Testing
- Transcatheter Aortic Valve Replacement (TAVR), Balloon Aortic Valvuloplasty (BAV)
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Opsens, Inc.
Aortic Stenosis, Aortic Insufficiency
First in Human Feasibility Study With ADAPT 3D - ALR for Aortic Leaflet Repair
This study will evaluate the safety and performance of the ADAPT 3D - ALR in adult patients requiring replacement of aortic valve. 15 patients in one site in Belgium will all be treated with ADAPT 3D - ALR.
- Trial name
- NCT04178213
- Testing
- Implantation of ADAPT 3D ALR
- Where
- Belgium
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
Aortic Valve Stenosis, Aortic Valve Insufficiency
Diagnostic Three Dimensional Echocardiography Study Protocol
The purpose of this study is to perform ground-based research to study what happens to the heart muscle in space. People who have problems with their aortic valve have an increase in the amount of muscle in the left ventricle of…
- Trial name
- NCT00598754
- Where
- United States
- Sponsor
- The Cleveland Clinic