Clinical trials: Cardiac Valve Surgery
Aortic Stenosis
Reactive Oxygen Species Following Aortic Valve Replacement
Surgical aortic valve replacement (SVAR) is currently the 'Gold Standard' therapy for patients with severe symptomatic aortic stenosis (AS).
- Trial name
- ROS (NCT02841917)
- Where
- United Kingdom
- Volunteers
- 3 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
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
Atrial Fibrillation, Valve
The Concomitant Cryomaze Procedure Using Nitreous Oxide Cryoprobe: Comparison With Argon Based Cryoprobe
The aim of this study is compare the surgical convenience and early and long-term outcomes of cryomaze procedure using nitrous oxide with using Argon gas.
- Trial name
- NCT01812356
- Testing
- Cryomaze procedure using Nitrous oxide, Cryomaze procedure using Argon
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- Samsung Medical Center
Bicuspid Aortic Valve, Aortic Regurgitation
Investigation of Patients With BAV Requiring Valve and/or Aortic Repair (GISSI Outliers VAR)
Prospective longitudinal study on four small groups of surgical patients affected by: BAV with isolated regurgitation, BAV associated with aorta dilatation, or both and BAV with isolated stenosis in over 60 year-old patients.
- Conditions
- Bicuspid Aortic Valve, Aortic Regurgitation, Aortic Dilatation
- Trial name
- VAR (NCT02283970)
- Where
- 10 sites in Italy
- Volunteers
- 62 people
- Sponsor
- Gruppo di Ricerca GISSI
Anesthesia
Ultrasound-guided Modified Transversus Thoracic Muscle Plane Block and Erector Spinal Muscle Plane Block in Heart Valve Replacement Surgery With Median Incision
Sternum midline incision can offer better view under open-heart surgery and bigger operating space, and therefore it has been widely used in most cardiac surgery.
- Trial name
- NCT06469073
- Testing
- Transversus thoracic muscle plane block or Erector spinal plane block
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Le Yu
Open Heart Surgery, Heart Valve Diseases
Acapella Versus Incentive Spirometer on Cardiopulmonary Fitness After Heart Valve Surgery.
Valvular heart disease (VHD) is a growing and important public health problem due to the increasing prevalence of degenerative VHD, accompanied by prolonged life expectancy in developed countries.
- Conditions
- Open Heart Surgery, Heart Valve Diseases, Heart Diseases
- Trial name
- NCT05522712
- Testing
- Acapella user, Incentive spirometer user, Control
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Cairo University
Aortic Valve Stenosis
Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI
Prospective, multi-centre, multi-national registry with a follow-up of 3 months, in five European countries and Canada (Toronto), with elective patients undergoing TF-TAVI (n=120) and isolated SAVR (n=120), respectively and a…
- Trial name
- TASQ (NCT03186339)
- Testing
- TAVI, SAVR, MM
- Where
- 10 sites in Austria, Canada and 5 more
- Volunteers
- 272 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Aortic Valve Stenosis
Measurement of Myocardial Stiffness Using Elastometry in Patients With Aortic Stenosis
Elastography is a new non-invasive medical technique for measuring the stiffness at a distance from a tissue. Recent advances in the development of elastography sequences for cardiac exploration suggest a more clinical approach…
- Trial name
- ELASTOP-AS (NCT04358692)
- Testing
- Aixplorer Mach30
- Where
- 2 sites in France
- Volunteers
- 98 people
- Sponsor
- University Hospital, Rouen
Hemorrhage, Valvular Heart Surgery
Dose-ranging Study of Tranexamic Acid in Valve Surgery
Cardiac surgical procedures account for a large amount of allogeneic transfusion. Tranexamic acid (TA), a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with…
- Trial name
- NCT01191554
- Testing
- Tranexamic Acid
- Where
- China
- Volunteers
- 175 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Patient With Clinically Indicated Invasive Monitoring
ClearSight System CHN Study
The purpose of this clinical trial is to demonstrate that cardiac output (CO) as determined with the Clinical Platform (Model:EV1000A, Software Version:1.9) in a noninvasive manner is comparable to CO as determined by Pulmonary…
- Trial name
- NCT03807622
- Testing
- EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System
- Where
- 3 sites in China
- Volunteers
- 125 people
- Sponsor
- Edwards Lifesciences
Cardiac Surgery, Peri Operative Medicine
Risk Factors of Atrial Fibrillation After Cardiac Surgery
Supraventricular arrhythmias complicate more than 40% of cardiac surgeries and are associated with an increased risk of bleeding, stroke, heart failure, and death.
- Conditions
- Cardiac Surgery, Peri Operative Medicine, Thoracic Surgery, Cardiopulmonary Bypass
- Trial name
- PFAS (NCT07625033)
- Where
- France
- Volunteers
- 918 people
- Sponsor
- Centre Hospitalier Régional Metz-Thionville
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
Aortic Valve Stenosis
Study to Improve Outcomes in Aortic Stenosis
Multi-centre, multi-national, observational, prospective registry in four central full access centres in Germany (2), France (1) and the United Kingdom (1) and up to two satellites per hub (smaller hospitals / office based…
- Trial name
- NCT03112629
- Where
- 2 sites in France, Germany
- Volunteers
- 791 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction
REVIVE-FR Registry
This registry aims to investigate treatment options for patients whose previously implanted biological aortic heart valve no longer functions properly.
- Conditions
- Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction, Structural Valve Deterioration, Prosthetic Heart Valve Thrombosis
- Trial name
- NCT07885761
- Testing
- TAVI-in-SAVR (Valve-in-Valve), THV-in-THV (Redo-TAVI), Surgical Explantation of a Failed Transcatheter Heart Valve
- Volunteers
- 200 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Heart Diseases, Heart Valve Diseases
To Investigate the Effect of Esketamine Hydrochloride on Pulmonary Complications
The objective of this study was to evaluate the effect of esketamine on intraoperative hemodynamics in patients with heart valve replacement and to mitigate postoperative pulmonary complications
- Trial name
- NCT06467513
- Testing
- Esketamine hydrochloride injection
- Where
- China
- Volunteers
- 102 people
- Sponsor
- Zhang XIao Mei
Atrial Fibrillation, Coronary Artery Disease
Prospective Project to Identify Biomarkers of Morbidity and Mortality in Cardiovascular Interventional Patients
The objective of CAREBANK study is to establish definitive relationships with human cardiac samples and clinical phenotypes in patients undergoing cardiac procedures.
- Conditions
- Atrial Fibrillation, Coronary Artery Disease, Aortic Valve Stenosis, Aortic Valve Disease
- Trial name
- CAREBANK (NCT03444259)
- Testing
- Cardiac surgery
- Where
- Finland
- Volunteers
- 1,001 people
- Sponsor
- University of Turku
Endocarditis
The Value of 99mTc-Leukoscan® Scintigraphy in the Diagnosis of Infectious Endocarditis on Surgical Materials
Infectious endocarditis is a serious pathology with difficult diagnosis especially on prosthetic valves or cardiac device because of the plurality of clinical presentations and the low sensitivity value of echocardiography in…
- Trial name
- PLEIM (NCT03112356)
- Testing
- 99mTc-Leukoscan® scintigraphy
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Hospices Civils de Lyon
Hemodynamic Monitoring, Cardiac Output
Stroke Volume Analysis During Aortic Valve Replacement Trial
Compromised peripheral tissue oxygenation during surgery may lead to worse patient outcome, mainly due to post-operative infections or heart failure.
- Conditions
- Hemodynamic Monitoring, Cardiac Output, Cardiac Surgery
- Trial name
- standart (NCT02156856)
- Where
- Germany
- Volunteers
- 68 people
- Sponsor
- Charite University, Berlin, Germany
Hypertrophic Obstructive Cardiomyopathy
Esmolol for Myocardial Protection in Hypertrophic Obstructive Cardiomyopathy
Perioperative blockage of beta-adrenoreceptors is widely used in cardiac and non-cardiac surgery to reduce the rate of cardiovascular complications.
- Trial name
- NCT05073094
- Testing
- Esmolol
- Where
- Russia
- Volunteers
- 80 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Mitral Regurgitation
Cardiovalve Transfemoral System - FIM Study
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
- Trial name
- NCT03958773
- Testing
- Cardiovalve transfemoral Mitral valve system
- Where
- Lithuania
- Volunteers
- 10 people
- Sponsor
- Cardiovalve Ltd.