Clinical trials: Cardiac Valve Surgery
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
Heart Diseases, Heart Diseases, Ischemic
Upper Extremity Elevation and Lungfunction After Open Heart Surgery
The purpose of this study is to assess if arm elevation, with or without simultaneous deep breathing, affects oxygen saturation and lung function on patients two to four days after open heart surgery.
- Conditions
- Heart Diseases, Heart Diseases, Ischemic, Heart Disease, Valvular
- Trial name
- NCT05278819
- Testing
- upper extremity elevation, upper extremity elevation with deep breathing
- Where
- Sweden
- Volunteers
- 22 people
- Sponsor
- Michael Reinhart
Sleep Disturbances, Postoperative Discomfort
Effect of Virtual Reality and Binaural Beat on Sleep and Comfort in Adults After Mechanical Valve Replacement Surgery
This study will compare the effects of Virtual Reality and Binaural Beat Stimulation on sleep quality and discomfort in adult patients who have undergone prosthetic mechanical valve replacement surgery.
- Conditions
- Sleep Disturbances, Postoperative Discomfort, Heart Valve Diseases
- Trial name
- VR-BBS (NCT07365488)
- Testing
- Virtual Reality Relaxation, Binaural Beat Stimulation, VR + Binaural Beat Group
- Where
- Iraq
- Volunteers
- 140 people
- Sponsor
- University of Baghdad
Aortic Valve Disease, Coronary Artery Disease
Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery
Controversies still exists concerning the overall clinical effects of blood-based vs. crystalloid- based cardioplegic solution for myocardial protection during cardiac arrest. Both techniques are used world-wide.
- Trial name
- NCT00257777
- Testing
- Myocardial protection techniques
- Where
- Norway
- Volunteers
- 350 people
- Sponsor
- Oslo University Hospital
Symptomatic Severe Aortic Stenosis
FlexNav EU CE Mark Study
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic…
- Trial name
- NCT03724812
- Testing
- Portico Valve and FlexNav™ Delivery System
- Where
- 6 sites in Denmark, Italy and 2 more
- Volunteers
- 46 people
- Sponsor
- Abbott Medical Devices
Frailty Syndrome, Quality of Life
Feasibility and Effectiveness of an Additional Resistance and Balance Training in Cardiac Rehabilitation of Older Patients After Valve Surgery or Intervention
The aim of the study is to evaluate the short- and medium-term effectiveness of additional moderate dynamic resistance and balance training to the CR-program of old adults after valve surgery or intervention compared to usual…
- Conditions
- Frailty Syndrome, Quality of Life, Valve Heart Disease
- Trial name
- NCT04234087
- Testing
- Additional balance and resistance training
- Where
- Lithuania
- Volunteers
- 116 people
- Sponsor
- Lithuanian University of Health Sciences
Coronary Artery Disease, Heart Valve Diseases
Is Myocardial Revascularization Really Necessary in Patients With ≥50-70% Coronary Stenosis Undergoing Valvular Surgery?
It is well documented in the literature that myocardial revascularization during valve surgery increases the risk of early mortality and morbidity.
- Trial name
- NCT05836467
- Testing
- Valvular interventions
- Where
- Italy
- Volunteers
- 77 people
- Sponsor
- Michele De Bonis
Heart Valve Surgery
Characterizations of Gut Microbiota and Postoperative Sleep in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass
The investigators designed a study to assess whether there is any change in gut microbiota and postoperative sleep before and after heart valve surgery with cardiopulmonary bypass.
- Trial name
- NCT05136001
- Testing
- polysomnography
- Where
- China
- Volunteers
- 36 people
- Sponsor
- China Medical University, China
Aortic Valve Disease, Surgery--Complications
Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)
There is considerable morbidity and mortality associated with cardiac surgery. Currently little effort is made to quantify how well the immune system of an individual can cope with inflammation or infection to which they are…
- Conditions
- Aortic Valve Disease, Surgery--Complications, Immune System Disorder
- Trial name
- Measure (NCT04430972)
- Testing
- Aortic valve replacement
- Where
- United Kingdom
- Volunteers
- 150 people
- Sponsor
- Barts & The London NHS Trust
Critical Aortic Stenosis
The Nordic Aortic Valve Intervention Trial
A randomized clinical trial of transcatheter aortic valve implantation (TAVI) versus conventional surgical aortic valve replacement (SAVR) in patients older than 70 years of age suffering from severe aortic valve stenosis.
- Trial name
- NOTION (NCT01057173)
- Testing
- Transcatheter Aortic Valve Implantation, Surgical Aortic Valve Replacement
- Where
- 3 sites in Denmark, Sweden
- Volunteers
- 280 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Aortic Stenosis
Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.
Study design: single arm, interventional and multicenter study. The objectives are evaluate Safety and efficacy of TAVI in Department of Cardiology without on site cardiac Surgery for symptomatic severe aortic valve stenosis by…
- Trial name
- NCT05886517
- Testing
- Transfemoral transcatheter aortic valve implementation
- Where
- 4 sites in Italy, Spain
- Volunteers
- 200 people
- Sponsor
- AUSL Romagna Rimini
Aortic Stenosis
18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes
This is a pilot study in which we will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity as measured by 18F-NaF PET/CT and any correlation to 1) valve…
- Trial name
- NCT03095313
- Testing
- 18F-NaF
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Cedars-Sinai Medical Center
Aortic Valve Disease
4D- Flow- MRI After Aortic Valve Surgery
This randomized controlled trial was designed to analyze flow patterns in the ascending aorta with MRI after either Trileaflet reconstruction of the aortic valve with autologous pericardium (TriRec) or surgical valve replacement…
- Trial name
- NCT04223713
- Testing
- TriRec, Aortic valve replacement
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Right Ventricular Dysfunction
TEE 3D RV Assessment for SAVR, Mini AVR, and TAVR
Three-dimensional echocardiography has become a gold standard to assess right ventricular (RV) function, and investigators plan to use 3D transesophageal echocardiography to assess RV function in 3 types of aortic valve…
- Trial name
- NCT05804240
- Testing
- 3D TEE RVEF
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- Thomas Jefferson University
Longstanding Persistent Atrial Fibrillation
Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation
Studies have shown that taking drugs to stay out of AF has limited success. This research is designed to study heart rhythm after surgical therapy, namely by measuring if there are benefits to having surgery to treat Atrial…
- Trial name
- CRYO-AF (NCT01558635)
- Testing
- Cardioblate CryoFlex Surgical Ablation, Mitral Valve surgery, Medtronic Reveal XT Insertable Cardiac Monitor
- Where
- 4 sites in Germany, Israel and 2 more
- Volunteers
- 17 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Congenital Heart Diseases, Aortic Valve Disorder
Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients
The investigators hope to learn 1) if the addition of prophylaxis with vancomycin will decrease the rate of cefazolin non-susceptible surgical site infections (SSI), in high risk population 2) to develop better understanding of…
- Trial name
- NCT01619982
- Testing
- Cefazolin 25 mg/kg body weight and Vancomycin hydrochloride, Cefazolin 30 mg/kg body weight
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Stanford University
Atrial Fibrillation (AF), Cerebral Vascular Accident (CVA)
Pilot Study to Determine the Optimal Protocol for Preoperative Transcutaneous Vagal Neurostimulation
Post-operative atrial fibrillation (POAF) is a frequent complication of surgical aortic valve replacement, affecting 38 to 63% of patients, and increasing risks of stroke, heart failure, and long-term mortality.
- Conditions
- Atrial Fibrillation (AF), Cerebral Vascular Accident (CVA), Heart Failure, Myocardial Infarction (MI)
- Trial name
- VAGASTIMA-PILT (NCT07891390)
- Testing
- tVNS session on the left earlobe
- Where
- 3 sites in France
- Volunteers
- 64 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Delirium - Postoperative, Sleep Problems
Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery
This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in adult patients undergoing…
- Conditions
- Delirium - Postoperative, Sleep Problems, CABG, Valve Surgery
- Trial name
- NCT06777342
- Testing
- Cognitive behavioral therapy intervention, Melatonin intervention
- Volunteers
- 1,281 people
- Sponsor
- Yan Fuxia
Hyperlactatemia, Cardiac Disease
Influence of High Vitamin C Dose on Lactate During and After Extracorporeal Circulation
The aim of our study is to find out whether high doses of vitamin C before cardiopulmonary bypass and during the first 24 hours after that have and impact of lowering the incidence of hyperlactatemia.
- Conditions
- Hyperlactatemia, Cardiac Disease, Bypass Complication, Valve Disease, Heart
- Trial name
- NCT04046861
- Testing
- ascorbic acid,
- Where
- Slovenia
- Volunteers
- 70 people
- Sponsor
- University Medical Centre Maribor
AORTIC VALVE DISEASES, Mitral Valve Failure
Advanced Robotic Beds for the Early Rehabilitation of Cardiac Surgery Patients
The goal of this clinical trial is to evaluate whether LOLE.K, a new and specialized robotic bed, is effective in the rehabilitation of patients who have undergone surgery.
- Trial name
- CARE (NCT07273669)
- Testing
- use of the robotic bed
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- University of Salerno