Clinical trials: Surgical Aortic Valve Replacement
Cardiac Surgical Procedures
Buckberg vs Del Nido in Isolated Aortic Valve Replacement
The study compares safety and efficacy of the Del Nido cardioplegic solution, comparing it with the Buckberg cardioplegic solution in single aortic valve replacement procedures.
- Trial name
- NCT04259515
- Testing
- Del Nido, Buckberg
- Where
- 2 sites in Spain
- Volunteers
- 286 people
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Aortic Valve Stenosis, Valve Heart Stenosis
Prospective European Multicenter Study on Aortic Valve Replacement: (E-AVR Registry)
Traditional and transcatheter surgical treatments of severe aortic valve stenosis (SAVS) are increasing in parallel with the improved life-expectancy.
- Trial name
- E-AVR (NCT03143361)
- Testing
- Aortic valve replacement
- Where
- Italy
- Volunteers
- 8,000 people
- Sponsor
- University of Parma
Heart Disease, Aging
Prevalence and Post-surgical Outcomes of CARdiac Wild-type TransthyrEtin amyloidoSIs in Elderly Patients With Aortic steNosis Referred for Valvular Replacement.
Background: The prevalence of both senile cardiac amyloidosis (CA) and aortic stenosis (AS) markedly increases with age. Aortic stenosis increases left ventricular pressure overload.
- Conditions
- Heart Disease, Aging, Amyloidosis, Aortic Valve Stenosis
- Trial name
- AMYLOCARTESIAN (NCT02260466)
- Testing
- a basal LV septum biopsy
- Where
- 5 sites in France
- Volunteers
- 186 people
- Sponsor
- French Cardiology Society
Coronary Disease, Shock, Cardiogenic
GLP-1 and Hyperoxia for Organ Protection in Heart Surgery
Patients undergoing open heart surgery are at risk of suffering damage to the heart, brain and kidneys. This study is designed as a 2-by-2 randomized clinical trial with the purpose of investigating the organ protective effects…
- Conditions
- Coronary Disease, Shock, Cardiogenic, Renal Failure, Stroke
- Trial name
- GLORIOUS (NCT02673931)
- Testing
- Byetta (Lilly, Exenatide), Conoxia (AGA, oxygen), 20% Human Albumin
- Where
- Denmark
- Volunteers
- 1,400 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Aortic Valve Stenosis, Cardiovascular Diseases
Comparison of TAVR With SAVR in Younger Low Surgical Risk Patients With Severe Aortic Stenosis
A randomized clinical trial investigating transcatheter (TAVR) versus surgical (SAVR) aortic valve replacement in patients 75 years of age or younger suffering from severe aortic valve stenosis.
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases
- Trial name
- NOTION-2 (NCT02825134)
- Testing
- Transcatheter aortic valve replacement, Surgical aortic valve replacement
- Where
- 9 sites in Denmark, Finland and 3 more
- Volunteers
- 376 people
- Sponsor
- Ole De Backer
Aortic Valve Stenosis, Coronary Artery Disease
Registry to Gather Long-time Results After Surgical Aortic Valve Replacement With a "Rapid Deployment Aortic Valve Prothesis (Edwards Intuity) Combined With Bypss Surgery (CABG)
This is a prospctive, unrandomized multicentric registry which will enrol patients with an indication for aortc valve replacement combined with myocardial reperfusion (CABG).
- Trial name
- INCA (NCT03326778)
- Testing
- AVR and CABG
- Where
- Germany
- Volunteers
- 220 people
- Sponsor
- Campus Bad Neustadt
Analgesia, Surgery
Serratus Anterior Plane Block Versus Standard of Care After Totally Endoscopic Aortic Valve Replacement
The aim of this study is to assess and compare the efficacy of a serratus anterior plane (SAP) block and our current pain protocol (Patient Controlled Intravenous Analgesia with opioids) in the prevention and treatment of acute…
- Conditions
- Analgesia, Surgery, Cardiac Disease
- Trial name
- NCT04699422
- Testing
- Serratus anterior plane block, PCIA with Piritramide
- Where
- Belgium
- Volunteers
- 80 people
- Sponsor
- Jessa Hospital
Aortic Root Aneurysm, Aortic Root Dissection
Aortic Valve Sparing Root Replacement Versus Bentall
This study was designed to evaluate the hypothesis that the operative and midterm results of valve-sparing aortic root replacement are equivalent to those of the Bentall.
- Trial name
- NCT03604913
- Testing
- Aortic valve sparing operation, Bentall operation
- Where
- Egypt
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Assiut University
Inflammation, Aortic Valve Stenosis
Is Monocyte/HDL Ratio a Predictor of Mortality in Aortic Valve Surgery
In this study, the investigators aimed to determine whether the preoperative Monocyte/HDL ratio would be a predictor of postoperative mortality and morbidity in patients who underwent aortic valve replacement due to aortic…
- Conditions
- Inflammation, Aortic Valve Stenosis, HDL
- Trial name
- NCT05641584
- Testing
- retrospective data review study
- Where
- Turkey (Türkiye)
- Volunteers
- 1 people
- Sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Symptomatic Severe Aortic Stenosis
Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients
The study objective is to demonstrate that the clinical outcomes of the Myval balloon-expandable THV series are non-inferior to those of SAVR in patients with symptomatic severe aortic stenosis aged 65 to 75 years.
- Trial name
- START YOUNG (NCT06861361)
- Testing
- Myval balloon-expandable THV Series, Surgical bioprosthetic valve
- Where
- 49 sites in Austria, Estonia and 12 more
- Volunteers
- 1,180 people
- Sponsor
- Ceric Sàrl
Cardiovascular Diseases
SAVR: IMPACT of Pre-existing Comorbidities on Patient Outcomes and Prosthetic Valve Performance in a Real-world Setting.
The IMPACT Registry represents a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years that includes data of patients undergoing aortic valve replacement with the Edwards…
- Trial name
- IMPACT (NCT04053088)
- Testing
- INSPIRIS RESILIA Aortic Valve™
- Where
- 22 sites in Austria, Germany and 2 more
- Volunteers
- 500 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Aortic Valve Stenosis
Aortic Valve replAcement in eLective Patients From aOrtic Valve multiceNter Registry
Multicenter registry data analysis of aortic valve stenosis patients that underwent elective, isolated transcutaneous aortic valve implantation (TAVI) or surgical aortic valve replacement between 2015 and 2019.
- Trial name
- AVALON (NCT05308173)
- Testing
- Surgical Aortic Valve Replacement, Transcutenous Aortic Valve Implantation
- Volunteers
- 2,393 people
- Sponsor
- Nicolaus Copernicus University
Valve Heart Disease
Post-surgical Aortic Hemodynamics After Aortic Valve Replacement
The purpose of this pilot study is to obtain both near valve and downstream flow characteristics, using 3D transthoracic echocardiography and 4D flow MRI respectively, in an existing patient population at Northwestern Memorial…
- Trial name
- NCT03347851
- Testing
- MRI, Transthoracic echocardiography exam
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- CryoLife, Inc.
Aortic Valve Surgery
Minimally Invasive Versus Conventional Aortic Valve Replacement: a Long Term Registry
The aim of the present study is to assess in a "real life" case list the outcome of three different surgical approaches for isolated aortic valve surgery in terms of surgery times, morbidity and mortality.
- Trial name
- SATURNO (NCT02278666)
- Testing
- aortic valve replacement, biological prosthetic valve, Mechanical valve
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- Maria Cecilia Hospital
Surgery, Hemodynamic Instability
Cell Salvage and Retrograde Autologous Priming
In recent years Patient Blood Management (PBM) has developed into a multifactorial and interdisciplinary concept that focuses on individualized and optimized hemotherapy.
- Trial name
- NCT04792814
- Where
- 2 sites in Germany
- Volunteers
- 200 people
- Sponsor
- University Hospital Schleswig-Holstein
Hyperglycemia, Aortic Valve Replacement
The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose
The overall research plan is to test the hypothesis that intraoperative treatment of hyperinsulinemic normoglycemic clamp (HNC) in cardiac surgical patients improves myocardial function and short-term outcomes compared with…
- Conditions
- Hyperglycemia, Aortic Valve Replacement, Aortic Stenosis, Cardiac Surgery
- Trial name
- NCT01187329
- Testing
- hyperinsulinemic normoglycemic clamp (HNC), control group
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- The Cleveland Clinic
Coronary Disease, Aortic Valve Stenosis
Quantitative Measurement of Myocardial Perfusion by Cardiac CT in Patients
It is a common understanding that patients with coronary heart disease are suffering, among others, from reduced myocardial perfusion.
- Trial name
- CCT/MPERF (NCT02361996)
- Where
- 3 sites in Austria, Russia and 1 more
- Volunteers
- 690 people
- Sponsor
- Bakulev Scientific Center of Cardiovascular Surgery
Delirium, Cognitive Impairment
Preoperative BAMCOG and Cortisol and Postoperative DeltaScan in AVR Patients (Aortic Valve Replacement)
There is lack of attention to preoperative cognitive function and delirium in elderly who underwent surgery. The investigators are investigating different tools that can help to screen for cognitive dysfunction and delirium in…
- Conditions
- Delirium, Cognitive Impairment, Cognitive Dysfunction, Cognitive Dysfunction, Postoperative
- Trial name
- NCT05209555
- Testing
- MoCA, BAMCOG, DeltaScan
- Where
- Netherlands
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Catharina Ziekenhuis Eindhoven
Aortic Stenosis
Treatment of Aortic Stenosis in Brazil: Cost-Utility Analysis of TAVI vs SAVR
TEAM-Br is a randomized, prospective, cost-utility study comparing transcatheter aortic valve implantation (TAVI) versus surgical aortic vale replacement in Brazil.
- Trial name
- TEAm-BR (NCT04067089)
- Testing
- TAVR - Transcatheter aortic valve replacement, Surgical aortic valve replacement
- Where
- Brazil
- Volunteers
- 126 people
- Sponsor
- Hospital do Coracao
Ascending Aorta Aneurism, Aortic Insufficiency
Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism
The investigators expect that the using of prothesis with sinuses has more benefits for long term competence and condition of aortic valve than the using of straight prothesis.
- Trial name
- EPSTAAA (NCT01456975)
- Testing
- Aortic valve reimplantation using Valsalva prosthesis
- Where
- Russia
- Volunteers
- 60 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation