Clinical trials: Aortic Stenosis With Bicuspid Valve
Aortic Stenosis
Transfemoral Transcatheter Aortic Valve Implantation With or Without Predilation of the Aortic Valve (EASE-IT TF)
Prior to the deployment of transcatheter heart valves (THV), balloon aortic valvuloplasty (BAV) is often performed under rapid right ventricular pacing (burst >180 bpm) with the induction of a functional cardiac arrest for up to…
- Trial name
- EASE-IT-TF (NCT02760771)
- Testing
- with BAV, without BAV
- Where
- Germany
- Volunteers
- 196 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Valvular Disease, Valvular Heart Disease
Epidemiology and Long-term Outcome of Patients With VHD
Valvular heart diseases are significant problem in Polish population. Coexistence of coronary artery disease in patients with VHD increases the risk of death and affects further therapeutic strategy.
- Conditions
- Valvular Disease, Valvular Heart Disease, Aortic Valve Stenosis, Mitral Insufficiency and Aortic Stenosis
- Trial name
- BIA-WAD (NCT04527367)
- Testing
- Innovative medical technologies in invasive cardiology and cardiac surgery
- Where
- Poland
- Volunteers
- 2,500 people
- Sponsor
- Medical University of Bialystok
Aortic Valve Stenosis, Cardiovascular Diseases
The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry
The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis.
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Valve Diseases, Bicuspid
- Trial name
- Bicuspid TAVR (NCT02394184)
- Testing
- transcatheter aortic valve replacement
- Where
- South Korea
- Volunteers
- 102 people
- Sponsor
- Seung-Jung Park
Aortic Valve Stenosis, Bicuspid Cardiac Valve
Addition of Computer Simulations to Minimize Adverse Events After Transcatheter Aortic Valve Implantation
The objective is to assess the influence of FEops HEARTguide on overall device success in TAVI patients with challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B).
- Trial name
- PRECISE_TAVI (NCT04473443)
- Testing
- FEops HEARTguideTM
- Where
- Netherlands
- Volunteers
- 200 people
- Sponsor
- Erasmus Medical Center
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
Coronary Artery Disease, Aortic Stenosis
The CardioPAT Project: A Randomized Trial
The purpose of this study is to determine whether intra- and postoperative use of the cardioPAT® cell saver decreases the need for allogenic red blood cell transfusion in patients, who undergo open heart surgery (with…
- Conditions
- Coronary Artery Disease, Aortic Stenosis, Aortic Insufficiency, Mitral Insufficiency
- Trial name
- NCT02058134
- Testing
- cardioPAT cell saver
- Where
- Denmark
- Volunteers
- 68 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Aortic Valve Stenosis, Aneurysm of Ascending Aorta
Progel Vascular Sealant
This study is being conducted to evaluate the safety and effectiveness of the Progel Vascular Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
- Conditions
- Aortic Valve Stenosis, Aneurysm of Ascending Aorta, Aortic Valve Disorder, Bicuspid Valve Disorder
- Trial name
- NCT01959503
- Testing
- Progel Vascular Sealant, Gelfoam Plus
- Where
- 19 sites in United States
- Volunteers
- 158 people
- Sponsor
- C. R. Bard
Aortic Valve Stenosis
Ascending Aortic Dilation in BiAV After TAVR
This study sought to evaluate changes in ascending aorta size after transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BiAV) compared with patients with tricuspid aortic valve (TAV).
- Trial name
- NCT03051334
- Testing
- diagnosed as bicuspid aortic valve
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Seoul National University Hospital
Aortic Valve Insufficiency, Aortic Valve Stenosis
Study of Administration Of Antithrombin in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery
General and specific objectives of the search: evaluate the effects of the administration of Antithrombin III (ATIII) on the activation of the coagulation system and of the fibrinolysis, platelet function, inflammatory response…
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Stenosis, Mitral Valve Insufficiency, Mitral Valve Stenosis
- Trial name
- ATIII (NCT01201070)
- Testing
- antithrombin III
- Where
- Italy
- Volunteers
- 90 people
- Sponsor
- University of Bari
Aortic Valve Disease
The Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients With Bicuspid Aortic Stenosis
Previous trials have shown that TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk.
- Trial name
- NCT03163329
- Testing
- TAVR, SAVR
- Volunteers
- 300 people
- Sponsor
- China National Center for Cardiovascular Diseases
Aortic Stenosis, Mitral Regurgitation
Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.
To evaluate whether patients after successful transfemoral transcatheter aortic valve implantation (TAVI), who have concomitant, moderate to severe mitral regurgitation (MR) benefit from an additional treatment of this valve…
- Trial name
- MITAVI (NCT04009434)
- Testing
- Mitral Valve Clipping, TAVI
- Where
- Germany
- Volunteers
- 1,162 people
- Sponsor
- Technische Universität Dresden
Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM)
Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.
Non-ischemic cardiomyopathies (NICM) represent a heterogeneous group of pathologies characterized by absence of obstructive disease of the epicardial coronary vessels and distinct structural and functional changes of the…
- Conditions
- Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM), Hypertrophic Cardiomyopathy (HCM), Restrictive Cardiomyopathy
- Trial name
- AINICM (NCT06607471)
- Testing
- Support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation, Support treatment, cardiac medical treatment, aetiology-specific treatment
- Where
- Italy
- Volunteers
- 15,000 people
- Sponsor
- Scientific Institute San Raffaele
Aortic Valve Stenosis, Aortic Valve Calcification
SLOW-Slower Progress of caLcificatiOn With Vitamin K2
A randomized 12-month trial will include two groups of 100 individuals aged over 50 years, with asymptomatic mild to moderate Aortic valve stenosis (AVA > 1 cm2, Vmax < 4 m/s).
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Mitral Annular Calcification, Mitral Valve Calcification
- Trial name
- NCT04429035
- Testing
- Vitamin K2
- Where
- 2 sites in Greece
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- National and Kapodistrian University of Athens
Hypertrophic Obstructive Cardiomyopathy
Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With Severe Mitral Insufficiency.
Compare the results of reconstruction and mitral valve replacement in the surgical treatment of obstructive hypertrophic cardiomyopathy with severe mitral insufficiency.
- Trial name
- NCT02054221
- Testing
- myoectomy, Mitral valve surgery
- Where
- Russia
- Volunteers
- 82 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Hypertrophic Cardiomyopathy
Mitral Valve Management During Septal Myectomy
Objective of the study: to evaluate whether alfieri technique improves clinical and hemodynamic results compared to transaortic mitral valve secondary cord cutting in patients scheduled to septal myectomy for severely symptomatic…
- Trial name
- MVMSM (NCT03906734)
- Testing
- Septal myectomy, alfieri stich, Subvalvular intervention
- Where
- Russia
- Volunteers
- 48 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Aortic Stenosis With Bicuspid Valve
Circle Method Observational Project - Non-interventional, Retrospective, Multicenter Data Collection
The goal of this non-interventional, retrospective data analysis is to validate the circle method for patients with bicuspid aortic heart valves undergoing transcatheter aortic heart valve implantation (TAVI).
- Trial name
- NCT05844969
- Where
- 4 sites in United Kingdom
- Volunteers
- 140 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Aortic Stenosis, Mitral Stenosis
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their…
- Conditions
- Aortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- COMMENCE (NCT01757665)
- Testing
- Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
- Where
- 32 sites in United States, Canada and 1 more
- Volunteers
- 777 people
- Sponsor
- Edwards Lifesciences
Bicuspid Aortic Valve
BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.
Prospective non interventional, observational registry of 150 patients undergoing TAVI with Evolut platform for bicuspid aortic stenosis.
- Trial name
- BIVOLUTX (NCT03495050)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- France
- Volunteers
- 150 people
- Sponsor
- Clinique Pasteur
Bicuspid Aortic Valve, Aortic Valve Stenosis
Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.
The goal of this prospective, non-randomized, single-center, observational study is to assess whether there is a progressive dilation of ascending aorta after surgical or transcatheter aortic valve replacement (TAVR) in patients…
- Conditions
- Bicuspid Aortic Valve, Aortic Valve Stenosis, Aortic Aneurysm, Heart Diseases
- Trial name
- ARDITAV (NCT05708118)
- Testing
- Echocardiographic assessment., Computed-tomography assessment
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Aortic Stenosis, Aortic Stenosis With Bicuspid Valve
HANGZHOU Solution in Bicuspid AS Undergoing TAVR
To compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic…
- Trial name
- NCT04722796
- Testing
- TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution), TAVR with Venus A plus using annular sizing and THV implantation technique
- Where
- 18 sites in China
- Volunteers
- 508 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine