Clinical trials: Aortic Valve Regurgitation.
Cardiac Valve Disease, Paravalvular Aortic Regurgitation
European Multicentre Registry of Percutaneous Paravalvular Leak Closure
Paraprosthetic cardiac valve leaks are a progressive complication after after surgical or percutaneous heart valve replacement. These leaks can lead to heart failure and/or life-threatening hemolysis.
- Conditions
- Cardiac Valve Disease, Paravalvular Aortic Regurgitation, Paravalvular Mitral Regurgitation, Paravalvular Leak
- Trial name
- EuroPVL (NCT05506293)
- Testing
- percutaneous paravalvular leak closure
- Where
- 33 sites in Belgium, Czechia and 10 more
- Volunteers
- 400 people
- Sponsor
- Centre Chirurgical Marie Lannelongue
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.
Mitral Regurgitation, Aortic Regurgitation
Expiratory Flow Limitation and Mechanical Ventilation During Cardiopulmonary Bypass in Cardiac Surgery
During general anesthesia a reduction of Functional Residual Capacity (FRC) was observed. The reduction of FRC could imply that respiratory system closing capacity (CC) exceeds the FRC and leads to a phenomenon called expiratory…
- Trial name
- NCT02633423
- Testing
- Use of PEEP before and after CPB, No use of PEEP before and after CPB(ZEEP), Ventilation with CPAP during CPB
- Where
- Italy
- Volunteers
- 204 people
- Sponsor
- Ospedale San Raffaele
Aortic Regurgitation
Safety and Effectiveness of TaurusTrio™ Heart Valve System in Patients With Severe Aortic Regurgitation (AR)
To evaluate the safety and effectiveness of the TaurusTrio™ Heart Valve System in a patient population with symptomatic severe AR requiring replacement/repair of their native aortic valve that are at high risk for open surgical…
- Trial name
- NCT06101888
- Testing
- TaurusTrio™ Heart Valve System
- Where
- 19 sites in China
- Volunteers
- 116 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
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 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
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 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
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
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
Cardiac T1 Mapping Enables Risk Prediction of LV Dysfunction After Surgery for Aortic Regurgitation
To assess whether cardiac T1 mapping for detection of myocardial fibrosis enables preoperative identification of patients at risk for early left ventricular dysfunction after surgery of aortic regurgitation.
- Trial name
- NCT05332184
- Testing
- aortic valve surgery
- Volunteers
- 40 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Aortic Regurgitation
THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study
To collect information about treatment for severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some…
- Trial name
- NCT02732704
- Testing
- JenaValve Pericardial TAVR System
- Where
- 19 sites in United States, Germany and 1 more
- Volunteers
- 100 people
- Sponsor
- JenaValve Technology, Inc.
Aortic Regurgitation, Functional Mitral Regurgitation
Fate of Moderate Secondary Mitral Regurgitation in Patients Undergoing Aortic Valve Surgery for Severe Aortic Regurgitation
Patients with severe aortic regurgitation (AR) may be affected, in many cases, by a concomitant moderate or severe mitral regurgitation (MR).
- Trial name
- NCT05774808
- Testing
- Aortic valve replacement, Mitral valve annuloplasty
- Where
- Italy
- Volunteers
- 154 people
- Sponsor
- Michele De Bonis
Aortic Stenosis
Videodensitometric Angiographic Assessment of AR in the Cath-lab for Intraprocedural Guidance of TAVI in CHINA
This clinical trial, a prospective, randomized, multicenter study, assigns patients to either videodensitometry-guided TAVI or conventional TTE/TEE-guided TAVI (stand of care), with the primary endpoint being regurgitation…
- Trial name
- NCT06891079
- Testing
- Videodensitometric guided, Stand of care guided
- Where
- 2 sites in China
- Volunteers
- 320 people
- Sponsor
- Xijing Hospital
Aortic Valve Disease
4D- Flow- MRI After Aortic Valve Surgery
This randomized controlled trial was designed to analyze flow patterns in the ascending aorta with MRI after either Trileaflet reconstruction of the aortic valve with autologous pericardium (TriRec) or surgical valve replacement…
- Trial name
- NCT04223713
- Testing
- TriRec, Aortic valve replacement
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Aortic Valve Stenosis, Mitral Regurgitation
Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions
Prospective, single-arm, observational study with invasive coronary physiology measurements before and after transcatheter left-sided valvular intervention.
- Conditions
- Aortic Valve Stenosis, Mitral Regurgitation, Coronary Artery Disease, Fractional Flow Reserve
- Trial name
- POTUS (NCT05374733)
- Testing
- Coronary Physiology assessment
- Where
- Netherlands
- Volunteers
- 150 people
- Sponsor
- Erasmus Medical Center
Hypertrophic Obstructive Cardiomyopathy, Mitral Regurgitation
Mitral Regurgitation in Hypertrophic Obstructive Cardiomyopathy: Fix it in a Simple, Effective and Durable Way!
Septal myectomy is performed in selected cases to treat patients with hypertrophic obstructive cardiomyopathy (HOCM). The mechanism that causes obstruction involves both the outflow tract itself and the mitral apparatus, with the…
- Trial name
- NCT05850026
- Testing
- Septal myectomy and mitral valve repair with edge-to-edge technique
- Where
- Italy
- Volunteers
- 26 people
- Sponsor
- Michele De Bonis
Aortic Valve Insufficiency, Aortic Valve Stenosis
Study of Administration Of Antithrombin in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery
General and specific objectives of the search: evaluate the effects of the administration of Antithrombin III (ATIII) on the activation of the coagulation system and of the fibrinolysis, platelet function, inflammatory response…
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Stenosis, Mitral Valve Insufficiency, Mitral Valve Stenosis
- Trial name
- ATIII (NCT01201070)
- Testing
- antithrombin III
- Where
- Italy
- Volunteers
- 90 people
- Sponsor
- University of Bari
Aortic Valve Replacement in Patients With Moderate Aortic Stenosis Combined With Mitral Regurgitation
Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis and Mitral Regurgitation
The aim of the present study is to investigate safety and efficacy of early versus deferred aortic valve replacement in patients with moderate aortic stenosis combined with moderate mitral regurgitation.
- Trial name
- TIAMAR (NCT05310461)
- Testing
- Transcatheter or surgical aortic valve replacement with or without transcatheter or surgical mitral valve repair/replacement, Deferred treatment, with intervention once AVA is ≤1.0 cm2 or if concomitant mitral regurgitation meets an indication for intervention
- Where
- 3 sites in Switzerland
- Volunteers
- 80 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Severe Aortic Stenosis or Severe Aortic Regurgitation
Prognostic Value of Soluble Urokinase-type Plasminogen Activator Receptor in Valvular Heart Disease
This study investigates the association between level of suPAR and valvular heart disease in patients who have severe aortic stenosis or severe aortic regurgitation using commercially available suPARnostic standard enzyme-linked…
- Trial name
- NCT04571372
- Where
- South Korea
- Volunteers
- 222 people
- Sponsor
- Yonsei University
Aortic Valve Regurgitation, Aortic Root Aneurysm
Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)
The objective of this study is to investigate safety and performance of the Free Margin Cusp sizer. The device will be used during aortic valve repair and sparing procedures as a caliper to measure the aortic valve free margin…
- Trial name
- CALIBRATE (NCT04797572)
- Testing
- Free Margin Cusp Sizer
- Where
- Belgium
- Volunteers
- 120 people
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain