Clinical trials: Heart Valve Surgery
Aortic Stenosis
TAVI Without On-Site Cardiac Surgery in Poland: A Randomized Multicenter Trial Protocol
Aortic stenosis (AS) represents the most prevalent acquired valvular heart disease in European populations, and transcatheter aortic valve implantation (TAVI) has become the dominant treatment modality for patients with…
- Trial name
- NOSCAR-TAVI (NCT07515768)
- Testing
- transcathter aortic valve implantation
- Volunteers
- 404 people
- Sponsor
- Medical University of Warsaw
Cardiovascular Diseases
Effectiveness and Safety of Mitral Valve Repair With the NeoChord DS1000 Artificial Chordae Delivery System Versus Conventional Surgery in Patients With Severe Primary Mitral Regurgitation Due to Isolated Leaflet Prolapse
The main objective is to assess the effectiveness and safety of the NeoChord DS1000 repair technique as compared with conventional open-heart on-pump mitral valve surgery in patients with severe primary mitral regurgitation.
- Trial name
- MITRACHORD (NCT02829749)
- Testing
- NeoChord beating heart mitral valve implantation, Control
- Where
- France
- Sponsor
- Hospices Civils de Lyon
Cardiac Infarct, Cardiac Valve Disease
Frailty, Physical Capacity and Lung Function in Postoperative Cardiac Surgery Patients
The goal of this observational and prospective study is to investigate changes in physical performance, lung function, and respiratory and peripheral muscle strength in patients during the postoperative period following coronary…
- Conditions
- Cardiac Infarct, Cardiac Valve Disease, Fragility, Physical Disability
- Trial name
- NCT06247358
- Where
- Brazil
- Volunteers
- 200 people
- Sponsor
- University of Sao Paulo General Hospital
Mitral Regurgitation (MR)
Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve Repair
This study aims to test the safety and effectiveness of Force Feedback instruments used during robotic-assisted mitral valve repair with the da Vinci Surgical System, Model IS5000 (dV5).
- Trial name
- NCT07655505
- Testing
- Mitral Valve Repair including the use of Force Feedback instruments
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Intuitive Surgical
Mitral Regurgitation, Mitral Stenosis
Acute Normovolemic Hemodilution on Serum-creatinine Concentration in Cardiac Surgery
Serum-creatinine level (s-Cr) is an important factor for predicting perioperative patient's outcome regarding acute kidney injury.
- Conditions
- Mitral Regurgitation, Mitral Stenosis, Tricuspid Regurgitation
- Trial name
- NCT02831270
- Testing
- Acute normovolemic hemodilution (ANH), hydroxyethyl starch (HES 130/0.6)
- Where
- South Korea
- Volunteers
- 32 people
- Sponsor
- Konkuk University Medical Center
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
Isolated Heart Valve Surgery
Continuation of Aspirin Before Isolated Heart Valve Surgery
Whether or not continuing aspirin up to de day before surgery increases the risk of bleeding and/or prevents thrombo-embolic complications remains debated.
- Trial name
- NCT05151796
- Testing
- Aspirin
- Where
- Belgium
- Volunteers
- 500 people
- Sponsor
- University of Liege
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE Study
The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.
- Trial name
- CADENCE (NCT02688153)
- Testing
- EDWARDS INTUITY, Stented aortic bioprostheses
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Parasternal vs. Sternotomy Approach for Conventional Aortic Valve Replacement
Prospective randomized study comparing aortic valve replacement using parasternal or sternotomy access with regard to quality of life and systemic inflammatory reaction.
- Trial name
- PASTA (NCT04632095)
- Testing
- Aortic valve replacement due to sternotomy, Aortic valve replacement due to parasternal right anterior mini-thoracotomy
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Jena University Hospital
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
Severe Mitral Valve Regurgitation (Disorder)
Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation
The mechanical intervention is treating secondary mitral regurgitation (SMR) which may be performed using the standard open surgical approach or transcatheter edge to edge repair (TEER).
- Trial name
- TEERMISO (NCT05090540)
- Testing
- Trancatheter Edge to Edge Repair, Mitral Valve Replacement, Restrictive Mitral Annuloplastie
- Where
- 2 sites in France
- Volunteers
- 600 people
- Sponsor
- Centre Cardiologique du Nord
Delirium, Cardiac Surgical Procedures
Dexmedetomidine Medication Records and Delirium After Coronary Artery Bypass Grafting
This retrospective observational study uses de-identified electronic health records from the TriNetX Global Collaborative Network. The procedure eligibility period is 1 January 2010 through 1 July 2025.
- Conditions
- Delirium, Cardiac Surgical Procedures, Coronary Artery Bypass Graft (CABG), Valve Surgery
- Trial name
- NCT07249164
- Testing
- Dexmedetomidine, No dexmedetomidine medication record in the specified window
- Where
- Taiwan
- Volunteers
- 343,112 people
- Sponsor
- China Medical University Hospital
Valvulopathy, Cardiac Surgery
Non-interventional Study Exploring the Composition of the Valvular Microbiota of Patients Undergoing Cardiac Surgery
The prevalence of aortic valve disease is increasing, with these valvulopathies present in half of individuals over the age of 65. Oberbach A.
- Conditions
- Valvulopathy, Cardiac Surgery, Microbiota
- Trial name
- BIOVALV (NCT07075601)
- Testing
- Take 1 ml of blood, DNA sequencing, Valve collection (healthcare waste)
- Where
- France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Toulouse
Aortic Stenosis
Effect of Steroids on Cerebral Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement
The purpose of this study is to investigate if methylprednisolone is effective in reducing the cerebral inflammatory response after open heart surgery with cardiopulmonary bypass.
- Trial name
- NCT01755338
- Testing
- Methylprednisolone
- Where
- Sweden
- Volunteers
- 30 people
- Sponsor
- Sahlgrenska University Hospital
Rheumatic Valve Disease
Clinical Trial of Electro-Acupuncture Preconditioning in Patients Underwent Heart Valve Replacement Surgery
The purpose of this study is to investigate the protective effect of electro-acupuncture preconditioning in patients underwent cardiac surgery.
- Trial name
- NCT00732459
- Testing
- Electro-acupuncture preconditioning
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Xijing Hospital
Valvular Heart Disease
Impact of Positive End-expiratory Pressure on Hepatic Venous Flow
The purpose of this study is to determine the difference in the impact of moderate positive end-expiratory pressure (PEEP) on hepatic venous flow Doppler in patients undergoing cardiac surgery: conventional versus protective…
- Trial name
- NCT02700581
- Testing
- low PEEP conventional ventilation, moderate PEEP conventional ventilation, low PEEP protective ventilation
- Volunteers
- 15 people
- Sponsor
- Konkuk University Medical Center
This Study is Being Conducted to Collect Echocardiographic Data to Test the Lumify Ultrasound With Hemodynamic Automation Device
Testing Automated Echocardiography
The purpose of this research is to determine if software can accurately predict certain heart parameters from chest wall ultrasound (non-radiation, non-invasive, imaging modality).
- Trial name
- NCT04943965
- Testing
- Ultrasound imaging
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Pennsylvania
Coronary Artery Bypass Graft and/or Aortic Valve Replacement Surgery
Sugammadex and Decreased Time to Extubation
The purpose of this study is to demonstrate faster time to extubation after arrival in the cardiothoracic intensive care unit (ICU) in patients undergoing isolated coronary artery bypass grafting (CABG), AVR and AVR/CABG…
- Trial name
- NCT03196167
- Testing
- Sugammadex
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Yale University
Postoperative Cognitive Dysfunction
Post Cardiac Surgery Neurocognitive Decline: Correlations Between Neuropsychological Tests and Functional MRI Techniques
Postoperative cognitive decline (POCD) is a frequent complication after cardiac surgery. It is estimated that 40-70% of all cardiac patients show cognitive dysfunction during the first post-surgical week.
- Trial name
- CardChNeuroMRI (NCT01622452)
- Volunteers
- 50 people
- Sponsor
- Fondazione Toscana Gabriele Monasterio
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