Clinical trials: Surgical Aortic Valve Replacement
Aortic Valve Stenosis
Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement
Multicenter, prospective, observational study in aortic stenosis (AS) patients undergoing transcatheter aortic valve implantation (TAVI) or high-risk patients undergoing aortic valve replacement (AVR).
- Trial name
- CCQ (NCT01852552)
- Testing
- transcatheter aortic valve implantation, Aortic Valve Replacement
- Where
- Italy
- Volunteers
- 518 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Aortic Stenosis
Microembolic Signals and Cerebrospinal Fluid Markers of Neuronal Damage After Surgical Aortic Valve Replacement
The use of MRI have shown that the incidence of postoperative cerebral lesions due to cerebral embolization is high (1). Nonetheless the extent of postoperative neurological dysfunction is only a fraction of the actual amount of…
- Trial name
- NCT01319799
- Testing
- Open heart surgery
- Where
- Sweden
- Volunteers
- 10 people
- Sponsor
- Sahlgrenska University Hospital
Aortic Valve Stenosis
Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients
The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe…
- Trial name
- NCT02701283
- Testing
- Medtronic Transcatheter Aortic Valve Replacement Systems, Surgical Aortic Valve Replacement (SAVR)
- Where
- 87 sites in United States, Australia and 5 more
- Volunteers
- 2,223 people
- Sponsor
- Medtronic Cardiovascular
Severe Aortic Valve Stenosis
In-vitro Benchmarking of Currently Available Heart Valve Prostheses for Surgical and Percutaneous Treatment of Aortic Stenosis With Small Annulus, Followed by In-vivo Validation
The general objective of this study is to compare in vitro and in vivo the hemodynamic performance of different types of aortic valve prostheses and possible surgical implantation techniques.
- Trial name
- SurPASS (NCT06859255)
- Testing
- MRI
- Where
- 2 sites in Italy
- Volunteers
- 200 people
- Sponsor
- IRCCS Policlinico S. Donato
Aortic Regurgitation, Aortic Valve Insufficiency
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System compared with surgical aortic valve replacement (SAVR) for treatment of subjects with clinically significant native aortic regurgitation (AR)
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency
- Trial name
- ARTIST (NCT06608823)
- Testing
- Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System, SAVR
- Where
- 38 sites in United States
- Volunteers
- 1,016 people
- Sponsor
- JenaValve Technology, Inc.
Aortic Stenosis
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
- Trial name
- P3 (NCT02675114)
- Testing
- SAVR, SAPIEN 3 THV
- Where
- 77 sites in United States, Australia and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Edwards Lifesciences
Cardiovascular Disease, Aortic Valve Stenosis
Evaluating the Risk of Cognitive Impairment After Surgical and Transcatheter Aortic Valve Replacement
The investigators are conducting a pilot study to compare cognitive outcomes among Veterans with severe aortic valve stenosis who are scheduled to undergo either aortic valve replacement.
- Conditions
- Cardiovascular Disease, Aortic Valve Stenosis, Cognitive Assessments, Valve Surgery
- Trial name
- CAVIAR (NCT02971020)
- Testing
- Observational/Cognitive Assessment
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Minnesota Veterans Medical Research and Education Foundation
Aortic Stenosis
Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients
To establish the safety and effectiveness of surgical aortic valve replacement (SAVR) in patients with isolated severe, calcific aortic stenosis who are at low surgical risk.
- Trial name
- AMETHYST (NCT06924151)
- Testing
- surgical aortic valve replacement, Transcatheter aortic valve replacement
- Where
- 37 sites in Japan
- Volunteers
- 450 people
- Sponsor
- Osaka University
Mitral Valve or Aortic Valve Replacement
A Retrospective Study to Collect the Data From the Patients Who Had the Perimount Heart Valve Replacement Surgery in China During 2001 to 2007
The objective of the study is to obtain the clinical data from patients who had the Perimount Heat Valve (Type:6900P and 2900) Replacement Surgery in Guangdong General Hospital during 2001-2007 in order to evaluate the performace…
- Trial name
- NCT02381678
- Testing
- Perimount 2900/6900 Heart Valve
- Where
- China
- Volunteers
- 225 people
- Sponsor
- Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.
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
Mitral Valve or Aortic Valve Replacement
Clinical Study to Evaluate the Performance of Perimount Heart Valve in Chinese Patients
To recruit patients who implanted with Perimount Heart Valve (Type Number: 6900PTFX or 2800TFX) from three hospitals in China. To track the patients'situations during one year after surgery and to collect the relevant clinical…
- Trial name
- NCT02400489
- Where
- 3 sites in China
- Volunteers
- 265 people
- Sponsor
- Edwards Lifesciences
Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis, Heye´s Syndrome
Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery
Acquired Von Willebrand disease (type 2A) has been described in patients with severe aortic stenosis, the association of aortic stenosis and Digestive bleeding due to this phenomena has received the name of Heye´s syndrome.
- Conditions
- Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis, Heye´s Syndrome, Severe Aortic Stenosis
- Trial name
- NCT01994330
- Testing
- desmopressin
- Where
- Chile
- Volunteers
- 13 people
- Sponsor
- Pontificia Universidad Catolica de Chile
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
Quality of Life
Health-related QoL Following TAVI TAo, TAVI TF and AVR
The aim of the study was to evaluate short- and long-term changes in QoL in patients undergoing TAVI and to assess differences in patient QoL when using the TAVI TAo approach compared with the transfemoral approach (TAVI TF) and…
- Trial name
- NCT03583398
- Testing
- transcatheter aortic valve implantation, surgical aortic valve replacement
- Volunteers
- 97 people
- Sponsor
- Medical University of Gdansk
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients…
- Trial name
- SURTAVI (NCT01586910)
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 86 sites in United States, Canada and 7 more
- Volunteers
- 1,746 people
- Sponsor
- Medtronic Cardiovascular
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.
Aortic Valve Disease
Long-Term Follow-up After the Autograft Aortic Valve Procedure (Ross Operation)
With the current knowledge of aortic valve replacement modalities, no specific recommendations can be given and the decision for a particular prosthesis or procedure is rather arbitrarily.
- Trial name
- NCT00708409
- Testing
- Cardiac valve surgery
- Where
- Germany
- Volunteers
- 1,800 people
- Sponsor
- University of Luebeck