Clinical trials: Surgical Valve Replacement
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
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
Heart Valve Replacement
The German Plug - Registry
In approximately 10-15% of all patients after surgical or interventional heart valve replacement, flapping defects appear as complications in the long-term course, so-called paravalvular / paraprothetic leaks (PVL).
- Trial name
- PLUG (NCT03179969)
- Testing
- paravalvular leak
- Where
- Germany
- Volunteers
- 49 people
- Sponsor
- Stiftung Institut fuer Herzinfarktforschung
Pleural Effusion, Coronary Artery Bypass
Pleural Effusion Following Cardiac Surgery: Prevalence, Risk Factors and Clinical Features
Pleural effusion is a common complication of cardiac surgery. The aim of this study was to determine the prevalence, characteristics and determinants of clinically significant pleural effusions, defined as those requiring…
- Trial name
- NCT00665015
- Where
- Canada
- Volunteers
- 2,892 people
- Sponsor
- Laval University
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
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
Cardiac Surgery, Coronary Artery Bypass Graft CABG
Effects of a Hybrid Model of Cardiac Rehabilitation on Patient Outcomes
Determine if the standard of care at a cardiac rehabilitation center using what the investigators term to be "hybrid model" on the exercise component of cardiac rehabilitation is associated with improved adherence and outcomes.
- Conditions
- Cardiac Surgery, Coronary Artery Bypass Graft CABG, Stent, Valve Replacement
- Trial name
- NCT06030115
- Testing
- Exercise Component Of Cardiac Rehabilitation (Hybrid Model) Intensity Recovery Progression Protocol (IRPP)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Good Shepherd Integrated Healthcare Systems
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
Right Ventricular Dysfunction
Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot
Background: Residual pulmonary regurgitation following repair of tetralogy of Fallot, in particular the use of a transannular patch, has been shown to correlate with the development of right ventricular dysfunction.
- Trial name
- TOF-Cond (NCT00557934)
- Testing
- dobutamine
- Where
- Germany
- Volunteers
- 16 people
- Sponsor
- University Hospital Tuebingen
Brain Excitability, Postoperative Delirium
Association Between the Brain Excitability and Postoperative Delirium in Patients Undergoing Heart Valve Replacement Surgery With Cardiopulmonary Bypass
The purpose of this study is to explorethe brain excitability in patients undergoing heart valve replacement surgery with cardiopulmonary bypass and the correlation with postoperative delirium
- Conditions
- Brain Excitability, Postoperative Delirium, Cardiac Surgery
- Trial name
- NCT05001425
- Where
- China
- Volunteers
- 90 people
- Sponsor
- General Hospital of Ningxia Medical 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.
Congenital Heart Disease
Autus Valve Pivotal Study
Prospective, single-arm, multi-center study to evaluate safety and effectiveness of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement.
- Trial name
- NCT05006404
- Testing
- Pulmonary Valve Replacement Surgery
- Where
- 12 sites in United States
- Volunteers
- 62 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Insufficiency, Atrial Fibrillation
Left Atrial Distensibility to Predict Left Ventricular Filling Pressure and Prognosis in Patients With Severe Mitral Regurgitation
A large left atrial (LA) volume, which represents chronic diastolic dysfunction, is associated with a poor outcome, regardless of systolic function.
- Conditions
- Mitral Valve Insufficiency, Atrial Fibrillation, Heart Failure
- Trial name
- NCT01172184
- Testing
- Cardiac catheterization
- Where
- Taiwan
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Kaohsiung Veterans General Hospital.
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
Postoperative Atelectasis
GO2 PEEP Study: Bidirectional Oxygenation Valve in Postoperative Atelectasis
This study compares a novel breathing device, called the GO2 Mouthpiece, to the standard breathing tool called the incentive spirometer, thus improving respiratory dynamics of the postoperative patient.
- Trial name
- NCT04253834
- Testing
- Incentive spirometer, GO2 Mouthpiece
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Emory University
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
Congenital Heart Disease
Autus Valve Continued Access Study (CAS)
Prospective, single-arm, multi-center, continued access study of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement.
- Trial name
- NCT07466745
- Testing
- Pulmonary Valve Replacement Surgery
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Edwards Lifesciences
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
Atrial Fibrillation
Amiodarone to Prevent Post-Operative Arrhythmias
Rapid heart rhythms originating from the upper heart chambers (atrial tachyarrhythmias) are very common after open-heart surgery.
- Trial name
- NCT00251706
- Testing
- amiodarone
- Where
- Canada
- Volunteers
- 600 people
- Sponsor
- University of Calgary
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