Clinical trials: Aortic Regurgitation Disease
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 Root Aneurysm, Aortic Regurgitation
Aortic Valve-sparing Root Replacement, According to the Inclusion Technique Described by Tirone David
Retrospective observational study of all patients undergoing aortic root surgery with aortic valve conservation, using the inclusion technique described by Tirone David, between January 1, 2004 and December 31, 2020, at six…
- Trial name
- AORTLANTIC (NCT05515848)
- Testing
- No intervention
- Where
- 5 sites in France
- Volunteers
- 529 people
- Sponsor
- Nantes University Hospital
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.
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 Regurgitation Disease
Aspirin Monotherapy Versus Sequential Warfarin-Aspirin Therapy After TAVR in Patients With Pure Aortic Regurgitation
This multicenter randomized controlled trial evaluates antithrombotic strategies post-TAVR in severe aortic regurgitation patients without long-term anticoagulation.
- Trial name
- AWATAR (NCT07677410)
- Testing
- Aspirin, Warfarin
- Where
- China
- Volunteers
- 1,172 people
- Sponsor
- Shanghai Zhongshan Hospital
Aortic Regurgitation, Aortic Disease
Prospective Multicenter Study Evaluating Myval TAVR Safety and Effectiveness in High-risk Severe AR
Prospective study is designed to evaluate the safety and efficacy of Myval THV series in patients with severe symptomatic non- or mild-calcified aortic regurgitation.
- Conditions
- Aortic Regurgitation, Aortic Disease, Calcified Aortic Valve
- Trial name
- MARVELTAVI (NCT07751965)
- Testing
- Myval THV series
- Volunteers
- 164 people
- Sponsor
- Ceric Sàrl
Cardiac Disease, Pulmonary Disease, Healthy Volunteer
Exploratory Study of the Diagnostic Potential of an Innovative Thoracic Vibration Analysis Technique
Heart and lung disease are two major causes of hospitalisation and mortality in France (4-8). Together, these two diseases affect several million people in France, either acutely or chronically.
- Conditions
- Cardiac Disease, Pulmonary Disease, Healthy Volunteer, Aortic Stenosis Disease, Mitral Regurgitation
- Trial name
- AIRFORCE2 (NCT06661200)
- Testing
- SMC signal recording
- Where
- France
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- University Hospital, Caen
Valvular Heart Diseases, Valvular Heart Disease Stenosis and Regurgitation
ECG and CXR for Predicting Cardiovascular Diseases
This retrospective multicenter cohort study aims to develop and validate an artificial intelligence model integrating electrocardiography (ECG) and chest radiography (CXR) to predict future progression of regurgitant valvular…
- Conditions
- Valvular Heart Diseases, Valvular Heart Disease Stenosis and Regurgitation, Regurgitation, Aortic Valve, Regurgitation, Mitral
- Trial name
- NCT07573852
- Where
- China
- Volunteers
- 116,380 people, healthy volunteers welcome
- Sponsor
- Shanghai Zhongshan Hospital
Aortic Valve Regurgitation, Aortic Valve Disease Mixed
J-Valve Transfemoral Pivotal Study
The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed…
- Trial name
- JOURNEY (NCT06455787)
- Testing
- J-Valve Transfemoral (TF) System
- Where
- 40 sites in United States, Canada and 3 more
- Volunteers
- 194 people
- Sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Mitral Regurgitation (MR), Moderate or Severe Aortic Stenosis (AS) (Mean Pressure Gradient ≥ 20 mm Hg or Aortic Valve Area ≤ 1.5 cm2)
Impact of Automatic Prompts in Echocardiographic Reports on Referral to Cardiology
Echo Prompts study is a multi-center randomized controlled study to evaluate the impact of automatic prompts added to the conclusion of the echocardiographic reports of patient diagnosed with significant VHD 1) suggesting…
- Trial name
- Echo Prompts (NCT06816888)
- Testing
- No Prompt, Prompt 1, Prompt 2
- Where
- Canada
- Volunteers
- 300 people
- Sponsor
- Ottawa Heart Institute Research Corporation
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
Sleep-disordered Breathing (SDB), Aortic Valve Stenosis
Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing
This prospective observational study aims to investigate the impact of transcatheter aortic valve implantation (TAVI) and transcatheter mitral valve edge-to-edge repair (M-TEER) on sleep-disordered breathing (SDB) in patients…
- Conditions
- Sleep-disordered Breathing (SDB), Aortic Valve Stenosis, Mitral Valve Regurgitation
- Trial name
- SLEEP-VALVE (NCT07520656)
- Where
- Greece
- Volunteers
- 150 people
- Sponsor
- Aristides Plaitis
Degenerative Aortic Valve Disease, Aortic Stenosis
Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA Trial
To date, no formal, randomized, prospective, head-to-head comparisons of surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) have been undertaken in the severe aortic stenosis (AS)…
- Conditions
- Degenerative Aortic Valve Disease, Aortic Stenosis, Aortic Regurgitation
- Trial name
- NCT03383445
- Testing
- Edwards, CoreValve, Acurate neo
- Where
- Canada
- Volunteers
- 300 people
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Aortic Regurgitation Disease
Artificial Intelligence in Aortic Regurgitation
This research project aims to develop and validate a tool that uses artificial intelligence (AI) to automatically detect and quantify aortic regurgitation (AR).
- Trial name
- NCT07486271
- Testing
- AI-Assisted Group, Manual measurement group
- Where
- Hong Kong
- Volunteers
- 540 people
- Sponsor
- Chinese University of Hong Kong
Aortic Valve Regurgitation, Aortic Valve Disease Mixed
JOURNEY LVAD: JOURNEY Left Ventricular Assist Device
The objective of this study is to assess the safety and effectiveness of the J-Valve Transfemoral Transcatheter Heart Valve System in patients on left ventricular assist device (LVAD) support with significant native aortic valve…
- Conditions
- Aortic Valve Regurgitation, Aortic Valve Disease Mixed, Aortic Insufficiency
- Trial name
- NCT07363473
- Testing
- J-Valve Transfemoral System
- Volunteers
- 50 people
- Sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
AORTIC VALVE DISEASES, Aortic Regurgitation
TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System
This study is a prospective, multicenter, non-randomized controlled trial, planning to enroll 180 patients with pure native aortic regurgitation.
- Conditions
- AORTIC VALVE DISEASES, Aortic Regurgitation, Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- TRAMPERS (NCT06818084)
- Testing
- VitaFlow+GDMT, J-Valve+GDMT
- Where
- 4 sites in China
- Volunteers
- 120 people
- Sponsor
- Ruijin Hospital
Aortic Regurgitation Disease, Aortic Stenosis Disease
Noninvasive Real-Time Arterial Waveform Monitoring for Cardiovascular Disease Assessment
The goal of this observational study is to learn whether noninvasive real-time arterial waveform monitoring can be used to assess cardiovascular diseases in adults.
- Conditions
- Aortic Regurgitation Disease, Aortic Stenosis Disease, Healthy Subjects
- Trial name
- NCT07350629
- Where
- China
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Anhui Provincial Cancer Hospital
Valve Heart Disease, Aortic Stenosis
Comparative Imaging Assessment of Valvular Heart Disease
The purpose of the study is to compare the various 2D and 3D methods of valvular heart disease quantification (Doppler, PISA, VCA, volumetric method) and strain with cardiac magnetic resonance (CMR) measurements of left and right…
- Conditions
- Valve Heart Disease, Aortic Stenosis, Aortic Regurgitation
- Trial name
- NCT04126018
- Testing
- MRI with strain measurement, Echocardiography
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- The Cleveland Clinic
Aortic Regurgitation Disease
The ARTEMIS Data Collection Study
To observe the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with evere native aortic regurgitation (AR) who are indicated for TAVR Data…
- Trial name
- ARTEMIS (NCT07075861)
- Where
- Italy
- Volunteers
- 75 people
- Sponsor
- IRCCS Policlinico S. Donato
Heart Valve Disease, Mitral Valve (MV) Regurgitation
Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease
The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging…
- Conditions
- Heart Valve Disease, Mitral Valve (MV) Regurgitation, Mitral Valve Disease, Mitral Valve Stenosis
- Trial name
- VALVE-COMPASS (NCT07267117)
- Where
- 15 sites in China
- Volunteers
- 10,000 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine