Clinical trials: Valve Surgery
Mitral Prosthetic Valve Stenosis and Regurgitation
Redo Surgery or Transcatheter Valve-in-Valve for Mitral Bioprosthetic Dysfunction (SURViV)
Transcatheter valve-in-valve implantation has emerged as a valid alternative to redo surgery for patients with surgical bioprosthetic dysfunction.
- Trial name
- SURVIV (NCT04402931)
- Testing
- Transcatheter Valve-in-Valve Intervention, Redo Mitral valve surgery
- Where
- 7 sites in Brazil
- Volunteers
- 150 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
Right Ventricle, Pulmonary Valve Stenosis
Follow Up on Freestyle Valves in Children
The purpose of this study is to determine if the Medtronic Freestyle porcine valve is effective over a long period of time when it is used to replace the valve that normally allows blood to flow from the right lower pumping…
- Conditions
- Right Ventricle, Pulmonary Valve Stenosis, Pulmonary Valve Atresia
- Trial name
- NCT00385112
- Testing
- Echocardiogram
- Where
- United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Emory University
Congenital Heart Disease
Autus Valve Continued Access Study (CAS)
Prospective, single-arm, multi-center, continued access study of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement.
- Trial name
- NCT07466745
- Testing
- Pulmonary Valve Replacement Surgery
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Edwards Lifesciences
Apical Hypertrophic Cardiomyopathy
Surgical Treatment of the Patients With Restrictive Phenotype of the Hypertrophic Cardiomyopathy Without LVOT Obstruction
Hypertrophic cardiomyopathy - is an inherited disease characterized by pronounced genetic and phenotypic heterogeneity. There are two most common anatomic variants of cardiac hypertrophy: subaortic and submitral phenotypes.
- Trial name
- NCT06977646
- Testing
- Surgical transaortic left ventricular cavity remodeling in patients with apical hypertrophic cardiomyopathy without left ventricular outflow tract obstruction
- Where
- Russia
- Volunteers
- 50 people
- Sponsor
- Petrovsky National Research Centre of Surgery
Aortic Valve Disease
Long-Term Follow-up After the Autograft Aortic Valve Procedure (Ross Operation)
With the current knowledge of aortic valve replacement modalities, no specific recommendations can be given and the decision for a particular prosthesis or procedure is rather arbitrarily.
- Trial name
- NCT00708409
- Testing
- Cardiac valve surgery
- Where
- Germany
- Volunteers
- 1,800 people
- Sponsor
- University of Luebeck
Ischemic Heart Disease, Valvular Heart Disease
Vigileo FloTrac vs Pulmonary Artery Catheter
To study the role of Vigileo monitor using the FloTrac sensor to measure cardiac output using the pulse contour analysis as well as central venous oxygen saturation monitoring as a guide for tissue perfusion.
- Trial name
- NCT00641290
- Testing
- Vigileo FloTrac Sensor
- Where
- Malaysia
- Volunteers
- 60 people
- Sponsor
- Hospital Sultanah Aminah Johor Bahru
Aortic Valve Stenosis
Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement
Multicenter, prospective, observational study in aortic stenosis (AS) patients undergoing transcatheter aortic valve implantation (TAVI) or high-risk patients undergoing aortic valve replacement (AVR).
- Trial name
- CCQ (NCT01852552)
- Testing
- transcatheter aortic valve implantation, Aortic Valve Replacement
- Where
- Italy
- Volunteers
- 518 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Coronary Artery Disease, Valvular Heart Disease
The ABC Trial Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery? A Single Centre Pilot Study
This study is a single centre pilot for a randomized trial comparing all-blood cardioplegia to more dilute 4:1 blood cardioplegia during cardiac surgery.
- Trial name
- ABC (NCT01623193)
- Testing
- All-blood cardioplegia, Standard cardioplegia
- Where
- Canada
- Volunteers
- 48 people
- Sponsor
- Pam Trenholm
Mitral Insufficiency, Pulmonary Arterial Hypertension
Surgical Valvuloplasty for Congenital Mitral Insufficiency
Congenital mitral insufficiency is one of the most common valvular diseases in the pediatric population worldwide, carrying a high morbidity and mortality risk if not treated immediately and properly.
- Trial name
- NCT03567668
- Testing
- mitral valvuloplasty
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Hong Liu
Aortic Regurgitation, Aortic Valve Insufficiency
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System compared with surgical aortic valve replacement (SAVR) for treatment of subjects with clinically significant native aortic regurgitation (AR)
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency
- Trial name
- ARTIST (NCT06608823)
- Testing
- Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System, SAVR
- Where
- 38 sites in United States
- Volunteers
- 1,016 people
- Sponsor
- JenaValve Technology, Inc.
Coronary Artery Bypass Grafting, Surgical Treatment for Heart Valve Diseases
China Cardiovascular Surgery Registry
China Cardiovascular Surgery Registry (CCSR) Study is a national database for coronary artery bypass grafting (CABG) and valve surgery performed in 87 hospitals with cardiovascular surgery volume > 100 per year.
- Trial name
- CCSR (NCT02400125)
- Where
- China
- Volunteers
- 90,000 people
- Sponsor
- China National Center for Cardiovascular Diseases
Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis, Heye´s Syndrome
Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery
Acquired Von Willebrand disease (type 2A) has been described in patients with severe aortic stenosis, the association of aortic stenosis and Digestive bleeding due to this phenomena has received the name of Heye´s syndrome.
- Conditions
- Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis, Heye´s Syndrome, Severe Aortic Stenosis
- Trial name
- NCT01994330
- Testing
- desmopressin
- Where
- Chile
- Volunteers
- 13 people
- Sponsor
- Pontificia Universidad Catolica de Chile
Mitral Regurgitation, Pain, Postoperative
Cryoablation of Intercostal Nerves for Pain Management in Early Postoperative Period in Patients With Minimally Invasive Mitral Valve Surgery
A single-center, pilot, prospective, randomized clinical trial with a 1:1 allocation ratio. The aim of our trial is to determine whether cryoablation of intercostal nerves provides a clinically significant analgesic effect, which…
- Trial name
- BLOCK (NCT06443931)
- Testing
- cryoablation of intercostal nerves
- Where
- Russia
- Volunteers
- 30 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Aortic Stenosis
TRanscatheter Aortic-Valve Implantation Without On-site Cardiac Surgery
TRACS-PRIME is a prospective, randomized, multicenter clinical trial evaluating whether transcatheter aortic valve implantation (TAVI) can be performed safely and effectively in selected hospitals without on-site cardiac surgery…
- Trial name
- TRACS-PRIME (NCT07604402)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- 11 sites in Italy
- Volunteers
- 1,612 people
- Sponsor
- University Hospital of Ferrara
Outcomes of Mitral Valve Surgery in Patients Affected by Rheumatic Heart Disease
Outcomes of Mitral Valve Surgery in Patients Affected by Rheumatic Heart Disease
rheumatic heart disease remains the majority valvular disease in low and middle income countries, which mostly affected mitral valve, surgical treatment is the most effective strategy to improve the outcomes of middle or…
- Trial name
- NCT04780607
- Testing
- mitral valve repair
- Where
- China
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- Beijing Anzhen Hospital
Congenital Heart Disease
Autus Valve Pivotal Study
Prospective, single-arm, multi-center study to evaluate safety and effectiveness of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement.
- Trial name
- NCT05006404
- Testing
- Pulmonary Valve Replacement Surgery
- Where
- 12 sites in United States
- Volunteers
- 62 people
- Sponsor
- Edwards Lifesciences
Pleural Effusion, Coronary Artery Bypass
Pleural Effusion Following Cardiac Surgery: Prevalence, Risk Factors and Clinical Features
Pleural effusion is a common complication of cardiac surgery. The aim of this study was to determine the prevalence, characteristics and determinants of clinically significant pleural effusions, defined as those requiring…
- Trial name
- NCT00665015
- Where
- Canada
- Volunteers
- 2,892 people
- Sponsor
- Laval University
Aortic Stenosis
Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients
To establish the safety and effectiveness of surgical aortic valve replacement (SAVR) in patients with isolated severe, calcific aortic stenosis who are at low surgical risk.
- Trial name
- AMETHYST (NCT06924151)
- Testing
- surgical aortic valve replacement, Transcatheter aortic valve replacement
- Where
- 37 sites in Japan
- Volunteers
- 450 people
- Sponsor
- Osaka University
Mitral Regurgitation (MR), Pediatric Cardiac Surgery
A Prospective Multicenter Cohort Study on Surgical Treatment Strategies for Pediatric Mitral Regurgitation
This prospective, multicenter cohort study aims to evaluate the outcomes of surgical repair for pediatric mitral regurgitation (MR) in China.
- Trial name
- NCT07284212
- Testing
- conventional mitral valve repair, standardized mitral valve repair
- Where
- China
- Volunteers
- 427 people
- Sponsor
- China National Center for Cardiovascular Diseases
Aortic Stenosis, Aortic Stenosis, Severe
PARTNER 3 Trial - Aortic Valve-in-Valve
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
- Trial name
- NCT03003299
- Testing
- Edwards SAPIEN 3/SAPIEN 3 Ultra THV
- Where
- 51 sites in United States, Canada
- Volunteers
- 125 people
- Sponsor
- Edwards Lifesciences