Clinical trials: Surgical Aortic Valve Replacement
Heart Valve Prosthesis, Aortic Stenosis
Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement
Multicenter randomised study which aims to compare sutureless Vs. standard bio- prostheses (1:1) among patients undergoing surgical aortic valve replacement in terms of: 6 -month hemodynamic performance.
- Conditions
- Heart Valve Prosthesis, Aortic Stenosis, Hemodynamics
- Trial name
- COPERA (NCT03965065)
- Testing
- Sutureless aortic bioprosthesis, Conventional stented sutured aortic prosthesis
- Where
- Spain
- Volunteers
- 350 people
- Sponsor
- Hospital San Carlos, Madrid
Aortic Valve Disorder
2D Strain of Right Ventricle in Peroperative of Cardiac Surgery
Evaluation of the right ventricle (RV) deformation (strain) with 2D speckle tracking technics obtained by echocardiographies (TEE) in peroperative period of cardiac surgery .
- Trial name
- NCT03298932
- Testing
- Aortic valve surgery
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Montpellier
Aortic Stenosis, Multi Vessel Coronary Artery Disease
The TransCatheter Valve and Vessels Trial
The trial objective is to investigate whether Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention (PCI) and TransCatheter Aortic Valve Implantation (TAVI) strategy for treatment of multivessel disease and…
- Conditions
- Aortic Stenosis, Multi Vessel Coronary Artery Disease, TAVI, CABG
- Trial name
- TCW (NCT03424941)
- Testing
- FFR-guided PCI and TAVI, CABG and SAVR
- Where
- 20 sites in Austria, Denmark and 8 more
- Volunteers
- 172 people
- Sponsor
- Maatschap Cardiologie Zwolle
Cardiac Surgery, Coronary Artery Bypass Graft
Micro- and Macro-Circulation in Cardiac Surgery Patients
The hypothesis under the study is that there could be a link between a dysfunction in peripheral microcirculation, sublingual microcirculation or cardiovascular control and the development of post cardiac surgery major…
- Conditions
- Cardiac Surgery, Coronary Artery Bypass Graft, Surgical Aortic Valve Replacement
- Trial name
- MiMaC (NCT05706545)
- Testing
- Acquisition of cardiovascular signals and microcirculation sidestream darkfield images
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- IRCCS Policlinico S. Donato
Prosthesis Survival, Prosthesis; Cardiac, Heart, Functional Disturbance as Result
Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement
The mechanical intervention is treating aortic valve stenosis (AVS) which may be performed using the standard open surgical approach for aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI).
- Trial name
- TAVISAR (NCT05261204)
- Testing
- Transcatheter Aortic Valve Implantation, Bioprothesis, Sutureless
- Where
- France
- Volunteers
- 4,000 people
- Sponsor
- Centre Cardiologique du Nord
Cardiac Surgery
Evaluate the Protective Effect of Conditioning With Sevoflurane on the Myocardium
Heart surgery is a considerable source of stress for the myocardium that must be minimized. Troponin Ic is a reliable marker to determine the level of this myocardial stress.
- Trial name
- SUPRA (NCT02851433)
- Testing
- total anaesthesia and postoperative inhaled sedation with Sevoflurane, total intravenous anaesthesia with Propofol.
- Where
- France
- Volunteers
- 82 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Neuropsychological and Neuroimaging Evaluation of the Cognitive Impairment in Aortic Valve Replacement (ARTiCO)
OBJECTIVE: To evaluate changes in cognitive performance in the early postoperative (1 month) and late (1 year) postoperative period in patients undergoing aortic valve replacement (SVAo) with surgery (SVA_Q) or transcatheter…
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement, Surgical Treatment, Cognitive Impairment
- Trial name
- ARTiCO (NCT05235529)
- Testing
- Aortic valve replacement, TAVI
- Where
- Spain
- Volunteers
- 72 people
- Sponsor
- Germans Trias i Pujol Hospital
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE-MIS Study
The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.
- Trial name
- CADENCE-MIS (NCT02672553)
- Testing
- EDWARDS INTUITY Valve System, Model 8300A, Stented Aortic Bioprostheses
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE Study
The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.
- Trial name
- CADENCE (NCT02688153)
- Testing
- EDWARDS INTUITY, Stented aortic bioprostheses
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Edwards Lifesciences
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 Stenosis
Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)
The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system.
- Trial name
- NCT01051518
- Testing
- Medtronic CoreValve System
- Where
- 9 sites in Canada, Germany and 2 more
- Volunteers
- 126 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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.
Aortic Valve Stenosis, Extracorporeal Circulation
Cerebral Embolic Load in Patients Undergoing Surgical Aortic Valve Replacement: A Comparison of the Conventional With the Minimized Extracorporeal Circulation Technique Using Transcranial Doppler Ultrasound
In this study, the investigators aim to compare cerebral embolic load in patients undergoing surgical aortic valve replacement using either the minimized extracorporeal circulation or the conventional extracorporeal circulation…
- Trial name
- AKE-MECC (NCT02308566)
- Testing
- Minimized Extracorporeal Circulation (MECC), Conventional Extracorporeal Circulation (CECC)
- Where
- Switzerland
- Volunteers
- 48 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Aortic Valve Stenosis, Endovascular Aortic Valve Replacement
Heart Leaflet Technologies Valve Study
The study will be conducted in patients who are undergoing surgical aortic valve replacement on cardiopulmonary bypass. Following surgical access of the native aortic valve and prior to removal of the valve, the native valve will…
- Trial name
- HLT (NCT00710775)
- Testing
- surgical replacement of the aortic stenotic valve
- Where
- Italy
- Volunteers
- 7 people
- Sponsor
- Centro Cardiologico Monzino
Aortic Valve Stenosis
Inflammatory Response to Aortic Valve Replacement
A controlled un-randomized trial where the inflammatory response in 18 patients admitted for TAVI procedure is compared to the inflammatory response in 18 patients admitted for conventional surgical valve replacement.
- Trial name
- NCT03074838
- Testing
- Transarterial aortic valve implantation - TAVI, Surgical aortic valve replacement - SAVR
- Volunteers
- 36 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
Aortic Valve Disease, Prosthesis; Cardiac, Heart, Functional Disturbance as Result
Aortic Valve Replacement Above the Aortic Annulus (SA-AVR) With the Carpentier-Edwards Magna-Ease Bioprosthesis
Surgical valve replacement is commonly performed in patients with severe aortic valve disease. In small aortic annulus, implantation of bioprosthetic valves can be associated with limited functional capacity.
- Trial name
- SA-AVR (NCT03976817)
- Testing
- aortic valve replacement
- Where
- France
- Volunteers
- 117 people
- Sponsor
- Centre Chirurgical Marie Lannelongue
Aortic Stenosis, Anxiety
10-year Follow-up After Aortic Valve Replacement Surgery
There is a lack of data on patients self-reported outcomes (PROMs) on health-related quality of life (HRQoL)and symptoms on anxiety and depression 10 years after Surgical After Aortic Valve Replacement (SAVR), and patient…
- Conditions
- Aortic Stenosis, Anxiety, Depressive Symptoms, Quality of Life
- Trial name
- AVR-10year (NCT06255691)
- Volunteers
- 282 people
- Sponsor
- Oslo University Hospital
Aortic Valve Stenosis
Evaluation of BAV in Different Hemodynamic Entities of Severe AS
The purpose of this retrospective, observational study is to compare the profit of BAV and TAVI in different subtypes of serve aortic stenosis.
- Trial name
- BAV (NCT04053192)
- Testing
- BAV, BAV + TAVR, SAVR
- Where
- Germany
- Volunteers
- 166 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT00636987
- Testing
- Biocor and Biocor Supra valves
- Where
- 17 sites in United States
- Volunteers
- 297 people
- Sponsor
- Abbott Medical Devices