Clinical trials: Heart Valve Surgery
Aortic Valve Disease, Cardiovascular Diseases
A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve
The goal of this clinical trial is to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve in subjects who are clinically indicated for aortic valve replacement.
- Trial name
- METASAR (NCT05941455)
- Testing
- Venus-Neo Surgical Aortic Valve
- Where
- Germany
- Volunteers
- 155 people
- Sponsor
- Jilin Venus Haoyue Medtech Limited
Cardiac Valve Disease, Coronary Artery Disease
The Val-CARD Trial
The Val-CARD trial aims to answer the question: "Does the drug sodium valproate reduce complications affecting the heart and kidneys in patients having heart operations?" Sodium valproate is a drug commonly used in the treatment…
- Conditions
- Cardiac Valve Disease, Coronary Artery Disease, Organ Failure, Multiple
- Trial name
- Val-CARD (NCT03825250)
- Testing
- Sodium Valproate
- Where
- United Kingdom
- Volunteers
- 45 people
- Sponsor
- University of Leicester
Cardiac Surgery
Nicotinamide Mononucleotide in Patients Undergoing Cardiac Surgery
The investigators will perform a phase 2a, randomized, double-blind, placebo-controlled clinical trial in adult patients undergoing elective cardiac surgery to investigate the effects of oral nicotinamide mononucleotide (NMN)…
- Trial name
- NCT07013591
- Testing
- MIB-626
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Brigham and Women's Hospital
Coronary Artery Disease, Aortic Valve Stenosis
Comparative Analysis of the Microcirculation During Cardiac Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation
The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery with minimal invasive versus conventional extracorporeal circulation.
- Conditions
- Coronary Artery Disease, Aortic Valve Stenosis, Mitral Disease
- Trial name
- NCT05479188
- Testing
- Sublingual microscopy
- Where
- Greece
- Volunteers
- 60 people
- Sponsor
- Aristotle University Of Thessaloniki
Anemia
Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery
The primary purpose of this study is to determine the best blood level to begin transfusing red blood cells in individuals undergoing cardiac surgery.
- Trial name
- NCT00651573
- Testing
- Blood transfusion at hematocrit value less than 24%, Blood transfusion at hematocrit value less than 28%
- Where
- 2 sites in United States, India
- Volunteers
- 722 people
- Sponsor
- The Cleveland Clinic
Cardiac Surgery, Coronary Artery Bypass
An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery
This study investigates the effect of two dose-levels of AP214 on the prevention of (acute) kidney injury after cardiac surgery.
- Conditions
- Cardiac Surgery, Coronary Artery Bypass, Aortic Aneurysm, Valve Surgery
- Trial name
- NCT01256372
- Testing
- AP214
- Where
- Denmark
- Volunteers
- 77 people
- Sponsor
- Action Pharma A/S
Mitral Valve Insufficiency, Mitral Regurgitation
Degenerative Mitral Regurgitation in Intermediate Risk Patients
The main objective of this project is to determine intermediate-term echocardiographic outcomes in Medicare eligible patients (65 years of age and older) with moderate surgical risk who have undergone mitral valve surgery for…
- Trial name
- DMR (NCT02604745)
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Northwestern University
Heart Failure, Excessive Amount of Blood / Fluid Transfusion
Anesthesia for Catheter Aortic Valve ImplantATIOn Registry
In modern cardiac surgery and cardiology Transcatheter Aortic Valve Implantation (TAVI) is an emerging procedure for high-risk patients that are assumed to be otherwise inoperable.
- Conditions
- Heart Failure, Excessive Amount of Blood / Fluid Transfusion, Intraoperative Cardiac Arrest During Cardiac Surgery, Critical Incident
- Trial name
- AVIATOR (NCT01390675)
- Where
- Germany
- Volunteers
- 10,000 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Aortic Valve Stenosis
Aortic Stenosis Associated Left Ventricular Remodeling - An Investigation of Genetic and Gender Specific Differences in 170 Patients Undergoing Aortic Valve Replacement Surgery
The goal of this study is to investigate the genetic and gender specific differences, in patients with low flow low gradient aortic stenosis and high flow high gradient aortic stenosis.
- Trial name
- SALVAGE (NCT05696145)
- Volunteers
- 170 people
- Sponsor
- Lisa Gundestrup
Postoperative Kidney Injury
Use of 6% Hydroxyethylstarch (130/0.4) in Cardiac Surgical Patients
The purpose of this study is to evaluate the safety of a standard volume replacement called HES 130/0.4 (Voluven) during surgery on recovery.
- Trial name
- SHARP (NCT02192502)
- Testing
- human albumin 5%, HES 130/0.4 (Voluven)
- Where
- United States
- Volunteers
- 149 people
- Sponsor
- The Cleveland Clinic
Aortic Valve Stenosis
Remote Ischemic Preconditioning in Aortic Valve Surgery
RIP-VALVE is a randomized, single blinded study that will test the hypothesis that remote ischemic preconditioning initiated before surgery reduces post-operative myocardial damage in aortic valve surgery.
- Trial name
- RIP-Valve (NCT01390129)
- Testing
- Control, Remote ischemic preconditioning
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Angers
Left Atrial Appendage Closure
Preventing Neurologic Complications in Valve Surgery
In patients with valvular heart disease and atrial fibrillation (AF) undergoing surgical valve surgery, current guidelines recommend concomitant surgical management of the left atrial appendage (LAA) to prevent postoperative…
- Trial name
- NCT07382362
- Testing
- Left Atrial Appendage (LAA) Suture Closure, Surgical Valve Surgery
- Where
- 4 sites in China
- Volunteers
- 100 people
- Sponsor
- China National Center for Cardiovascular Diseases
Postoperative Complications, Heart Diseases
Detection of Right Ventricular Dysfunction by Portal Vein Doppler After Cardiac Surgery
Right ventricular (RV) failure after cardiac surgery is associated with morbidity and mortality, but is hard to diagnose with conventional echocardiographic means.
- Conditions
- Postoperative Complications, Heart Diseases, Heart Failure, Heart Valve Diseases
- Trial name
- DVDDP (NCT04890860)
- Testing
- cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass
- Where
- France
- Volunteers
- 70 people
- Sponsor
- CMC Ambroise Paré
Aortic Stenosis, Anxiety
10-year Follow-up After Aortic Valve Replacement Surgery
There is a lack of data on patients self-reported outcomes (PROMs) on health-related quality of life (HRQoL)and symptoms on anxiety and depression 10 years after Surgical After Aortic Valve Replacement (SAVR), and patient…
- Conditions
- Aortic Stenosis, Anxiety, Depressive Symptoms, Quality of Life
- Trial name
- AVR-10year (NCT06255691)
- Volunteers
- 282 people
- Sponsor
- Oslo University Hospital
Aneurysm Aortic Root, Aortic Valve, Bicuspid
Aortic Valve Dynamics During Exercise After Valve Sparing Root Replacement Surgery
Aortic valve sparing operations are applied in patients with a non-calcified tricuspid or bicuspid aortic valve associated with a root aneurysm, in order to preserve the valve, and avoid new aortic dilatation by stabilizing the…
- Trial name
- NCT04205474
- Testing
- graded bicycle test
- Where
- Belgium
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University Hospital, Ghent
Aortic Valve Disease, Aortic Stenosis
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively.
- Trial name
- PERSIST-AVR (NCT02673697)
- Testing
- Perceval valve, other stented biological valve
- Where
- 47 sites in United States, Austria and 10 more
- Volunteers
- 914 people
- Sponsor
- Corcym S.r.l
Mitral Regurgitation
Haemodynamics of Mitral Regurgitation Reduction
There is uncertainty in terms of the superiority of conventional valve surgery or percutaneous transcatheter intervention for the treatment of severe mitral regurgitation (MR) in high risk patients.
- Trial name
- STRESS-MR (NCT05403840)
- Testing
- Mitral valve surgery, Transcatheter mitral valve intervention
- Volunteers
- 60 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Congenital Heart Disease
Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery
Cardiac surgery relieves symptoms and increases life expectancy in cardiac patients, with and without congenital heart disease (CHD).
- Trial name
- BOCA (NCT01184404)
- Testing
- Bosentan
- Where
- Netherlands
- Volunteers
- 100 people
- Sponsor
- Berto J Bouma
Aortic Regurgitation Disease, Aortic Valve Calcification
Valvular Assessment of New Generation Aortic Replacement Devices
The VANGUARD study is an open-label, prospective, randomized trial comparing the long-term outcomes of two advanced bioprosthetic aortic valves, Dafodil® and INSPIRIS Resilia®, in patients undergoing aortic valve replacement…
- Conditions
- Aortic Regurgitation Disease, Aortic Valve Calcification, Bicuspid Aortic Valve Disease
- Trial name
- VANGUARD (NCT06688448)
- Testing
- Dafodil prosthesis, Aortic Valve Replacement - Inspires Resilia prosthesis
- Where
- Brazil
- Volunteers
- 200 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
Heart Valve Diseases, Mitral Valve Disease
PROMISE: Percutaneous peRipheral cannulatiOn for Minimally-InvaSive Heart Valve surgEry
In addition to conventional heart valve surgery (HVS) via full-sternotomy, which is still the most prevalent therapeutic strategy to address valvular heart disease (VHD), minimally-invasive approaches evolved as safe…
- Conditions
- Heart Valve Diseases, Mitral Valve Disease, Aortic Valve Disease, Tricuspid Valve Disease
- Trial name
- NCT05961150
- Where
- Germany
- Volunteers
- 1,000 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf