Clinical trials: Aortic Surgery
Aortic Valve Stenosis
Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Low to Intermediate Risk of Mortality
Randomized controlled, multi-center trial randomizing patients with symptomatic severe aortic stenosis at low to intermediate operative risk of mortality in a 1:1 fashion to transcatheter aortic valve implantation (TAVI) or…
- Trial name
- DEDICATE (NCT03112980)
- Testing
- Transcatheter aortic valve implantation, Surgical aortic valve replacement
- Where
- 43 sites in Germany
- Volunteers
- 1,414 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Aortic Valve Stenosis
Nitinol Circular Blade
The Nitinol Circular Blade (NCB) is indicated for use in patients with symptomatic aortic stenosis requiring aortic valve replacement, who are going to be operated by conventional sternotomy with native valve resection and…
- Trial name
- NCB (NCT03881527)
- Testing
- Aortic valve replacement using a nitinol blade, aortic valve replacement
- Where
- Belgium
- Volunteers
- 40 people
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Early Assessment of AKI After TAAA Repair
Multicenter Assessment of a Bedside-testing System (Nephrocheck™) for Acute Kidney Injury After Thoracoabdominal Aortic Surgery
Assessment of postoperative acute kidney insufficiency according to the KDIGO classification using the Nephrocheck system. Multicentric, prospective study Open TAAA Repair in 3-4 centers in Germany and Europe
- Trial name
- NCT04087161
- Testing
- Nephrocheck bed side testing of AKI
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- RWTH Aachen University
Paravalvular Aortic Regurgitation
PARADIGM: Amplatzer Valvular Plug for PVL Closure
The Paradigm study is a prospective, multicenter, single arm study to demonstrate the safety and effectiveness of the Amplatzer Valvular Plug III (AVP III) as a treatment for clinically significant PVLs following surgical implant…
- Trial name
- PARADIGM (NCT04489823)
- Testing
- AVP III
- Where
- 24 sites in United States, Canada and 5 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Thoracic Aneurysm, Aneurysm Stent
The Effects of Anesthesia on Patients Undergoing Surgery for Repair of a Thoracoabdominal Aneurysm.
Alzheimer's disease represents a growing public health problem in developed countries. Although the pathogenesis is not clearly defined, accumulation of extracellular amyloid, neurofibrillary tangles and neuronal loss are the…
- Conditions
- Thoracic Aneurysm, Aneurysm Stent, Cardiopulmonary Bypass, Abdominal Aneurysm
- Trial name
- NCT01772537
- Testing
- Propofol, isoflurane
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Johns Hopkins University
Aortic Valve Stenosis
Detecting Changes in Arterial Blood Volume and Cardiac Efficiency
The objective of this Pilot Study is to demonstrate the efficacy of the Hemocept device in detecting changes in arterial blood volume and cardiac efficiency.
- Trial name
- NCT07205341
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- HemoCept Inc.
Aortic Aneurysm, Aortic Aneurysm and Dissection
Multidisciplinary Analysis by Morphological and Mechanical Evaluation of the Aortic Wall in Patients Undergoing Cardiac Surgery.
Surgical indication in patients suffering from Ascending aorta aneurysm is currently based mainly on the maximum diameter of the aortic dilatation and on the yearly growth rate.
- Trial name
- NCT07422129
- Where
- Italy
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Aortic Dissection
Aortic-Stent-Register
The aims of the aorta-stent-Registry are: participating hospitals (with audit) document all consecutive patients diagnosed with a disease of the distal thoracal aorta that receive one of the following therapies:
- Trial name
- NCT01197651
- Where
- 8 sites in Germany
- Volunteers
- 199 people
- Sponsor
- Stiftung Institut fuer Herzinfarktforschung
Aortic Valve Stenosis
REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects
REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects
- Trial name
- REPRISE IV (NCT03618095)
- Testing
- LOTUS Edge Valve System
- Where
- 50 sites in United States, Australia
- Volunteers
- 382 people
- Sponsor
- Boston Scientific Corporation
Cerebrovascular Circulation
Cerebral Perfusion in Hypothermic Circulatory Arrest
Selective antegrade cerebral perfusion (sACP) during aortic arch surgery in hypothermic circulatory arrest (HCA) is an established method for intraoperative neuroprotection.
- Trial name
- NCT03484104
- Testing
- Measurement of tissue oxygenation index (TOI)
- Where
- 2 sites in Switzerland
- Volunteers
- 40 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
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
Thoracoabdominal Aortic Aneurysm
A PMCF Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch Stent Graft System (INNER-B-APAC)
The INNER-B-APAC post-market clinical follow-up study is undertaken to demonstrate the safety and clinical performance of the E-nside TAAA Multibranch Stent Graft System used in endovascular treatment of patients with…
- Trial name
- NCT05954793
- Where
- 8 sites in Australia, New Zealand and 1 more
- Volunteers
- 16 people
- Sponsor
- JOTEC GmbH
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 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.
Symptomatic Non-ruptured Abdominal Aortic Aneurysms
Investigating Practice Patterns in Symptomatic Non-ruptured Abdominal Aortic Aneurysms (AAA) in Europe
Symptomatic non-ruptured abdominal aortic aneurysms (snrAAA) remain a clinical challenge due to limited evidence and heterogeneous definitions and management strategies.
- Trial name
- DETHINE (NCT07184723)
- Where
- Austria
- Volunteers
- 130 people
- Sponsor
- Wilhelminenspital Vienna
Functional Mitral Regurgitation
Treatment of Moderate FMR During AVR
Debates exist on the treatment of moderate functional mitral regurgitation (FMR) in patients undergoing aortic valve replacement (AVR) for aortic valve disease.
- Trial name
- NCT05566340
- Testing
- mitral valve repair
- Volunteers
- 154 people
- Sponsor
- Fuwai Yunnan Cardiovascular Hospital
Cardiac, Aortic Arch Surgery
Brain Vascular Reactivity to Hypothermic Circulatory Arrest With Antegrade Cerebral Perfusion During Aortic Arch Surgery
Many neonates and infants who undergo complex cardiac surgery are affected by neurological developmental delays. Whilst catastrophic events are immediately identifiable from clinical examination or by macro changes on MRI or CT…
- Conditions
- Cardiac, Aortic Arch Surgery, Brain Vascular, Neonates
- Trial name
- NCT03047876
- Testing
- aortic arch surgery
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Alder Hey Children's NHS Foundation Trust
Echocardiography, Aortic Valve
Short- and Medium-term Results of New Generation Aortic
Over the past decade, aortic valve replacement surgery has undergone significant changes in terms of both the approaches and the prostheses used.
- Conditions
- Echocardiography, Aortic Valve, Cardiac Surgery, Mortality
- Trial name
- RVANG (NCT05055089)
- Where
- France
- Volunteers
- 172 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Aortic Valve Stenosis
PrizValve® Transcatheter Aortic Valve Replacement Study
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not…
- Trial name
- NCT04836897
- Testing
- PrizValve® valve and transapical delivery system
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Acute Mesenteric Ischemia, Sepsis Bacterial
Performance of the SeptiCyte LAB Test for Antibiotic Stewardship in Mesenteric Ischemia
This study will help determine whether the SeptiCyte LAB test can accurately differentiate between SIRS and actual infections in postoperative patients, potentially reducing unnecessary antibiotic use and improving patient…
- Conditions
- Acute Mesenteric Ischemia, Sepsis Bacterial, Intra-abdominal Infection, Digestive Inflammation
- Trial name
- SPASM (NCT06507423)
- Testing
- Septicyte Lab Test pre operative, Septicyte Lab Test post operative
- Where
- France
- Volunteers
- 15 people
- Sponsor
- Central Hospital, Nancy, France