Clinical trials: Aortic Valve Surgery
Cardiopulmonary Bypass, Cardiac Surgery
Ulinastatin Improves Postoperative Oxygenation After Cardiopulmonary Bypass
Retrospective study determine whether ulinastatin enhances postoperative pulmonary oxygenation after cardiopulmonary bypass (CPB).
- Trial name
- NCT03154814
- Testing
- ulinastatin, control
- Where
- 2 sites in South Korea
- Volunteers
- 80 people
- Sponsor
- Konkuk University Medical Center
Intensive Care Unit, Coronary Artery Bypass Grafting (CABG)
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany and Italy. A total of 550 high-risk cardiac surgery patients will receive either 0.20 g fish oil/kg body weight…
- Conditions
- Intensive Care Unit, Coronary Artery Bypass Grafting (CABG), High Risk Patients, Cardiopulmonary Bypass
- Trial name
- MODIFY CSX (NCT06279793)
- Testing
- Fish Oil, Intravenous 0.9% Sodium Chloride
- Where
- 10 sites in Germany
- Volunteers
- 550 people
- Sponsor
- GCP-Service International West GmbH
Minimal Invasive Cardiac Surgery, Mitral Valve Surgery
Serratus Anterior Plane Block for Minimal Invasive Cardiac Surgery
Analgesia in cardiac surgery is historically based on large doses of intravenous opioids. However, this practice is rapidly changing due to "Enhanced Recovery After Surgery (ERAS)" protocols with proven benefits on morbidity and…
- Conditions
- Minimal Invasive Cardiac Surgery, Mitral Valve Surgery, Aortic Valve Replacement, Minimal Invasive Direct Coronary Artery Bypass
- Trial name
- NCT05107453
- Testing
- Levobupivacaine
- Where
- Belgium
- Volunteers
- 80 people
- Sponsor
- Algemeen Ziekenhuis Maria Middelares
Efficacy and Safety of Novel Bidirectional Cannula
Novel Bidirectional Peripheral Artery Cannula in Minimally Invasive Aortic Valve Surgery
The aim of this study is to evaluate the safety and efficacy of the novel bidirectional cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable distal perfusion compared to conventional cannula with downstream…
- Trial name
- NCT04402372
- Testing
- Novel bidirectional cannula (BiflowTM, LivaNova, Italy)
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Ankara City Hospital Bilkent
Aortic Valve Stenosis
Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study
The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are…
- Trial name
- NCT05864456
- Testing
- Prizvalve Pro™ transcatheter aortic valve system
- Where
- China
- Volunteers
- 73 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Ascending Aorta Aneurism, Aortic Insufficiency
Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism
The investigators expect that the using of prothesis with sinuses has more benefits for long term competence and condition of aortic valve than the using of straight prothesis.
- Trial name
- EPSTAAA (NCT01456975)
- Testing
- Aortic valve reimplantation using Valsalva prosthesis
- Where
- Russia
- Volunteers
- 60 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Coronary Artery Bypass Grafting, Heart Diseases
The Short Form-36: Pre- Versus Post-Surgical Administration in Cardiac Surgery Patients
The purpose of this study is to determine whether the SF-36 can be administered reliably to cardiac surgery patients (two to three days) post-surgery, with the patient answering the questions of this survey from a pre-surgical…
- Conditions
- Coronary Artery Bypass Grafting, Heart Diseases, Heart Valve Diseases
- Trial name
- NCT00226265
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Weill Medical College of Cornell University
Symptomatic Severe Aortic Stenosis
Portico Next Generation Approval Study
The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the…
- Trial name
- NCT04011722
- Testing
- Portico™ NG (Navitor) Valve and FlexNav™ Delivery System, Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
- Where
- 28 sites in United States, Australia and 3 more
- Volunteers
- 333 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis, Gender
TAVI and Gender Outcomes Aortic Stenosis Undergoing Transfemoral Transcatheter Aortic Valve Implantation.
Severe aortic stenosis (AS) is the commonest form of valvular abnormality in the developed world and transcatheter aortic valve implantation (TAVI) is now widely practiced as in many cases is the preferred treatment option over…
- Conditions
- Aortic Stenosis, Gender, Surgery
- Trial name
- NCT04915976
- Volunteers
- 14,086 people, healthy volunteers welcome
- Sponsor
- Imperial College Healthcare NHS Trust
Heart Valve Prosthesis, Aortic Stenosis
Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement
Multicenter randomised study which aims to compare sutureless Vs. standard bio- prostheses (1:1) among patients undergoing surgical aortic valve replacement in terms of: 6 -month hemodynamic performance.
- Conditions
- Heart Valve Prosthesis, Aortic Stenosis, Hemodynamics
- Trial name
- COPERA (NCT03965065)
- Testing
- Sutureless aortic bioprosthesis, Conventional stented sutured aortic prosthesis
- Where
- Spain
- Volunteers
- 350 people
- Sponsor
- Hospital San Carlos, Madrid
Coronary Artery Disease, Aortic Valve Disease
Clinical Evaluation of a Modular Extracorporeal Circulation Circuit
The purpose of this clinical research study is the design of a novel modular hybrid system extracorporeal circulation circuit for open heart procedures that could easily be converted from a closed to a semi-closed circuit…
- Conditions
- Coronary Artery Disease, Aortic Valve Disease, Mitral Valve Disease, Aortic Aneurysm
- Trial name
- MiECC MODULAR (NCT02000544)
- Testing
- Modular Cardiopulmonary Bypass Circuit
- Where
- Greece
- Volunteers
- 403 people
- Sponsor
- AHEPA University Hospital
Heart Diseases, ASD - Atrial Septal Defect
Abbott Structural Heart Device Registry
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting.
- Conditions
- Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PFO - Patent Foramen Ovale
- Trial name
- SH-Registry (NCT06590467)
- Testing
- Amplatzer™ Occlusion Devices, Epic™ Surgical Tissue Heart Valve devices
- Where
- 36 sites in United States, Denmark and 8 more
- Volunteers
- 2,500 people
- Sponsor
- Abbott Medical Devices
Cardiovascular Disease
FEIBA and Use of Blood Products in Cardiac Surgery
The purpose of this pilot study is to evaluate the feasibility of the prophylactic administration of Factor VIII Inhibitor Bypass Activity (FEIBA) at termination of cardiopulmonary bypass (CPB) period.
- Trial name
- FEIBA (NCT02577614)
- Testing
- FEIBA, Normal Saline
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Oregon Health and Science University
Cardiac Valve Disease, Aortic Valve Disease
The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy
Rationale: Patients awaiting cardiac surgery can experience pre-procedural anxiety. This anxiety is associated with increased analgesic needs, increased risk of mortality and prolonged recovery time.
- Conditions
- Cardiac Valve Disease, Aortic Valve Disease, Mitral Valve Disease, Tricuspid Valve Disease
- Trial name
- NCT06001489
- Testing
- 360-degree Virtual Reality Patient Tour, State Trait Anxiety Inventory, Amsterdam Preoperative Anxiety and Information Scale
- Where
- Netherlands
- Volunteers
- 100 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Aortic Valve Stenosis With Insufficiency, Aortic Valve Stenosis
Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.
- Trial name
- TRITON (NCT01445171)
- Testing
- Aortic Valve Replacement with EDWARDS INTUITY Valve System
- Where
- 6 sites in Austria, Germany
- Volunteers
- 295 people
- Sponsor
- Edwards Lifesciences
Myocardial Ischemia, Coronary Arteriosclerosis
Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery
The purpose of this study is to determine if the study drug (TP10), which blocks complement release, can reduce such side effects of complement inflammation as chest pain or heart attacks and be taken safely in women who undergo…
- Conditions
- Myocardial Ischemia, Coronary Arteriosclerosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- NCT00082121
- Testing
- TP10
- Where
- 18 sites in United States
- Volunteers
- 300 people
- Sponsor
- Avant Immunotherapeutics
Coronary Artery Disease, Mitral Valve Insufficiency
The Effects of Sevoflurane, Isoflurane and Propofol During Cardiac Surgery
Abstract Anaesthetic support for cardiac surgery significantly influences the course of the intraoperative period and the success of the postoperative period.
- Conditions
- Coronary Artery Disease, Mitral Valve Insufficiency, Aortic Valve Insufficiency
- Trial name
- NCT05695287
- Testing
- Propofol, Isoflurane, Sevoflurane
- Where
- Kazakhstan
- Volunteers
- 89 people
- Sponsor
- Astana Medical University
Surgery, Survival, Prosthesis
15 Years Outcomes Following Bioprosthetic vs Mechanical Aortic Valve Replacement Between 50-65 Years
Currently there is an increase in the use of bioprosthesis worldwide (> 70% according to national data of the Spanish Society of Thoracic and Cardiovascular Surgery).
- Conditions
- Surgery, Survival, Prosthesis, Valve Heart Disease
- Trial name
- ANDALVALVE (NCT03239509)
- Testing
- bioprosthesis implantation between 2000-2015, mechanical prosthesis implantation between 2000-2015
- Where
- 7 sites in Spain
- Volunteers
- 1,200 people
- Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Coronary Arterial Disease (CAD), Valve Replacement
Prolonged Chest Tube Treatment to Reduce Rates of Atrial Fibrillation Following Cardiac Surgery
Evacuation of pericardial blood by posterior pericardiotomy or use of a posterior pericardial chest tube lowers postoperative atrial fibrillation (POAF) rates after cardiac surgery by 45-68%.
- Conditions
- Coronary Arterial Disease (CAD), Valve Replacement, Aortic Surgery
- Trial name
- PROPER (NCT06800781)
- Testing
- Prolonged treatment with posterior pericardial chest tube plus standard care
- Where
- Sweden
- Volunteers
- 624 people
- Sponsor
- Region Skane
Aortic Valve Stenosis, Ventricular Hypertrophy
Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis
The purpose of the study is to see if statin therapy will optimize myocardial response to cardiopulmonary bypass during aortic valve replacement (AVR) for aortic valve stenosis (AVS) (Phase I) and optimize left ventricular…
- Trial name
- NCT00811330
- Testing
- Atorvastatin 80 mg
- Where
- France
- Volunteers
- 60 people
- Sponsor
- University Hospital, Strasbourg, France