Clinical trials: Cardiac and Aortic Surgery
Aortic Stenosis
Regression of Myocardial Fibrosis After Aortic Valve Replacement
Aortic stenosis (AS) is the most common valvular heart condition in the United Kingdom and the Western world. Surgery for severe AS prior to symptom onset is controversial.
- Trial name
- RELIEF-AS (NCT02174471)
- Where
- United Kingdom
- Volunteers
- 181 people
- Sponsor
- University College, London
Cardiac Septal Defects With Coarctation of the Aorta, Mitral Regurgitation
Comparison of Erector Spinae Block and Pecto-Intercostal Facial Block For Enhanced Recovery in Adult Cardiac Surgery
The current study is designed to compare the perioperative analgesic efficacy of Erector spinae plane block (ESPB) and Pecto-intercostal-fascial plane block (PIFB) in adults undergoing cardiac surgery via median sternotomy.
- Trial name
- NCT05475561
- Testing
- Ultrasound guided Pecto-intercostal- fascial plane block, Ultrasound guided erector spinae plane block, Bupivacain
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Alexandria University
Aortic Valve Stenosis
Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device
This registry is designed to monitor the real world clinical performance and safety of the V8 device used to perform balloon aortic valvuloplasty (BAV).
- Trial name
- TAB-R (NCT02099942)
- Testing
- V8 Balloon Aortic Valvuloplasty (BAV) Catheter
- Where
- 7 sites in United States
- Volunteers
- 103 people
- Sponsor
- InterValve, Inc.
Heart Valve Diseases, Left Ventricle Remodeling
Effect of Losartan on the Neurohumoral Axis and Ventricular Remodeling of Patients With Severe Aortic Regurgitation Undergoing Valve Surgery.
Why Is This Study Important? The heart has valves that help control blood flow. Aortic regurgitation (AR) is a condition where one of these valves (the aortic valve) doesn't close properly, causing blood to leak back into the…
- Conditions
- Heart Valve Diseases, Left Ventricle Remodeling, Aortic Regurgitation Disease, Heart Failure Congestive
- Trial name
- ARBNP (NCT07099859)
- Testing
- Losartan 50 mg
- Where
- Brazil
- Volunteers
- 60 people
- Sponsor
- Vitor Emer Egypto Rosa
Cardiovascular Disease
Protective Effect of CoQ10 Against Negative Inflammatory Response and Organ Dysfunction in Cardiovascular Surgery (PANDA V)
Cardiovascular diseases are the leading causes of death and prescription drug use. Research on certain dietary supplements looks promising as a way to help reduce risk factors.
- Trial name
- PANDA (NCT04444349)
- Testing
- Coenzyme Q10, Standard Medical Therapy
- Where
- 4 sites in China
- Volunteers
- 500 people
- Sponsor
- Nanjing Medical University
Paroxysmal Atrial Fibrillation, Coronary Artery Disease
Surgical Pulmonary Vein Isolation Efficiency Study
A substantial proportion of patients undergoing elective coronary artery bypass grafting have a history of paroxysmal atrial fibrillation. Paroxysmal atrial fibrillation has adverse short-and long term postoperative effects.
- Trial name
- FIN-PVI (NCT01791218)
- Testing
- CABG, AVR or CABG+AVR and PVI, CABG, AVR or CABG+AVR
- Where
- Finland
- Volunteers
- 2 people
- Sponsor
- Kuopio University Hospital
AORTIC VALVE DISEASES, Mitral Valve Disease
Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve
The goal of this clinical trial is to explore the early feasibility, initial safety, and efficacy of surgical implantation of a polymer prosthetic heart valve in patients requiring either mitral valve replacement or aortic valve…
- Conditions
- AORTIC VALVE DISEASES, Mitral Valve Disease, Aortic Stenosis, Aortic Regurgitation
- Trial name
- POLYVALVE-FIH (NCT07097740)
- Testing
- Polymer Prosthetic Heart Valve
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Mitrassist Lifesciences Limited Co., Ltd.
Coarctation of Aorta
The Effect of Paravertebral Block With Dexamethasone on Intraoperative and Postoperative Analgesia in Children Undergoing Surgery for Coarctation of Aorta
Anesthetic management for surgery of aortic coarctation needs special care due to severe pain during lateral thoracotomy incision, the intraoperative hemodynamic instability related to skin incision at lateral thoracotomy…
- Trial name
- NCT03074773
- Testing
- Dexamethasone, ultrasound, paravertebral block
- Where
- Egypt
- Volunteers
- 50 people
- Sponsor
- Cairo University
Hypoplastic Left Heart Syndrome (HLHS), Aortic Arch Hypoplasia
Seeking for Perfected Aortic Arch Reconstruction Using a Graphically Designed Patient-specific Surgical Patch
Vascular Reconstruction is one of the most challenging areas of surgery, the surgeon has to create a completely watertight reconstruction without any narrowing or deformity that will restore normal flow characteristics, even at…
- Trial name
- NCT06853054
- Testing
- Personalized patch template
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- The Hospital for Sick Children
Valve Disease, Heart, Atrial Fibrillation (AF)
Apixaban VS Warfarin in AF Pts First Three Months After Repair or BIO AVR MVR
SAFE-HEART is a single-centre, randomized controlled trial comparing the safety and efficiency of Apixaban versus Warfarin in the early period (3 months) after repair or bioprosthetics of the mitral and aortic valve cardiac…
- Conditions
- Valve Disease, Heart, Atrial Fibrillation (AF), Valve Replacement Surgery, Aortic Valve Surgery
- Trial name
- SAFE-HEART (NCT07434661)
- Testing
- Apixaban, Warfarin
- Where
- Russia
- Volunteers
- 120 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Cardiac Surgery, Heart Surgery
Safety and Performance Evaluation of CPB Venous and Arterial Cannulas
This is a two-phase study evaluating the Eurosets arterial and venous cannulas for use during cardiopulmonary bypass (CPB) procedures. Phase 1 is a pilot study focused on assessing cannula safety.
- Conditions
- Cardiac Surgery, Heart Surgery, Cardiopulmonary Bypass, Coronary Surgery
- Trial name
- NCT07354841
- Testing
- Eurosets Venous and Arterial Cannula, Control Arterial and Venous Cannulas
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Eurosets S.r.l.
Prehabilitation, Cardiac Surgery
Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy
Rationale Cardiac surgery via median sternotomy carries an elevated risk of postoperative complications and delayed functional recovery.
- Conditions
- Prehabilitation, Cardiac Surgery, Risk Assesment, Aortic Valve
- Trial name
- PREPA-STER (NCT07893184)
- Testing
- Physical Prehabilitation Intervention
- Where
- Netherlands
- Volunteers
- 24 people
- Sponsor
- Maastricht University Medical Center
Aortic Stenosis, Valvular Heart Disease
Severe Aortic Stenosis in Patients Referred for Valve Surgery
Our main hypothesis on the present study is that new parameters such as risk-taking behavior, patients motivation, health related quality of life, new biomarkers and more precise echocardiography measures in addition to…
- Conditions
- Aortic Stenosis, Valvular Heart Disease, Symptomatic Aortic Stenosis
- Trial name
- SAS (NCT01794832)
- Where
- Norway
- Volunteers
- 500 people
- Sponsor
- Oslo University Hospital
Bicuspid Aortic Valve
Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
- Trial name
- NCT03635424
- Testing
- Medtronic TAVR Systems
- Where
- 25 sites in United States
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiovascular
Patients With Elective Aortic Valve Replacement
Remote Ischemic Preconditioning Induces Myocardial RISK Signaling Pathway in Patients Undergoing Valvular Heart Surgery
The aim of this study is to investigate whether RIPC protects the heart against ischemia reperfusion injury on the concentrically hypertrophied myocardium
- Trial name
- NCT01946087
- Testing
- Remote ischemic preconditioning at left upper arm, Control group
- Where
- South Korea
- Volunteers
- 79 people
- Sponsor
- Yonsei University
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 Surgical Procedures
Diagnostic Accuracy of Doppler Resistive Indices for Early Diagnosis of Acute Kidney Injury .
To determine if ultrasound measurement of renal and carotid arterial resistive indices are associated with post-cardiac surgery acute kidney injury.
- Trial name
- NCT02580292
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Michigan
Aortic Valve Stenosis, Heart Valve Diseases
Quality of Life After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement
This is a single-center, single-blind, all comer, randomized controlled trial. Patients scheduled for isolated aortic valve replacement (AVR) due to aortic stenosis at "Virgen de la Victoria Universitary Hospital", Málaga, Spain…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease
- Trial name
- QUALITY-AVR (NCT02726087)
- Testing
- ministernotomy, Full sternotomy
- Where
- Spain
- Volunteers
- 96 people
- Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Aortic Valve Stenosis
PremiCron Suture for Cardiac Valve Repair
The study is a voluntary study, initiated by B. Braun to collect clinical data for PremiCron® suture concerning its key indication.
- Trial name
- PremiValve (NCT04096859)
- Where
- 2 sites in Germany, Spain
- Volunteers
- 198 people
- Sponsor
- Aesculap AG
Coronary Disease
Reduced Manipulation of the Aorta and Neurobehavioral Outcome Trial
The purpose of this trial is to determine whether aortic manipulation in patients undergoing coronary bypass graft surgery leads to increased incidence of microemboli and subsequent impairment of neurobehavioral function.
- Trial name
- NCT00059319
- Testing
- single aorta clamp with retrograde cardioplegia, multiple aorta clamps with antegrade cardioplegia
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)