Clinical trials: Heart Valve Prosthesis
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
Atrial Fibrillation, Deep Vein Thrombosis
Randomized Trial of Interventions to Improve Warfarin Adherence
The purpose of this research study is to see if a lottery which provides the opportunity to win money, a reminder system using a "Med-eMonitor", or the combination of both might be useful in helping patients to achieve better…
- Conditions
- Atrial Fibrillation, Deep Vein Thrombosis, Dilated Cardiomyopathies
- Trial name
- WIN3 (NCT00904982)
- Testing
- Financial Incentive and Med-eMonitor, 2Med-eMonitor
- Where
- 2 sites in United States
- Volunteers
- 268 people
- Sponsor
- University of Pennsylvania
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 Valve Stenosis, Valve Heart Stenosis
Prospective European Multicenter Study on Aortic Valve Replacement: (E-AVR Registry)
Traditional and transcatheter surgical treatments of severe aortic valve stenosis (SAVS) are increasing in parallel with the improved life-expectancy.
- Trial name
- E-AVR (NCT03143361)
- Testing
- Aortic valve replacement
- Where
- Italy
- Volunteers
- 8,000 people
- Sponsor
- University of Parma
Heart Valve Diseases, Aortic Valve Stenosis
BIOVALVE - I / II Clincial Investigation
First-in-Human clinical investigation to evaluate the safety and clinical performance of the BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis, which are as judged by the heart team…
- Trial name
- BIOVALVE (NCT02249000)
- Testing
- BIOVALVE prosthesis
- Where
- 13 sites in Belgium, Germany and 2 more
- Volunteers
- 68 people
- Sponsor
- Biotronik AG
Hypoprothrombinemia
Randomized Controlled Feasibility Trial of the Fearon Algorithm to Improve Management of Unstable Warfarin
Patients on warfarin but with unstable international normalized ratio (INR) will be recruited to a randomized trial comparing dosing based on an algorithm (Fearon algorithm, named after the mathematician Michael Fearon), which…
- Trial name
- NCT02267408
- Testing
- Warfarin adjustment using the Fearon algorithm, Warfarin adjustment using standard dosing
- Where
- Canada
- Volunteers
- 42 people
- Sponsor
- McMaster University
Atrial Fibrillation, Venous Thromboses
Pharmacogenetic Dosage Algorithm for Acenocoumarol
The use of coumarins has been a challenge for doctors because of its narrow therapeutic range and they show great inter and intra-individual variability in the dose necessary to achieve an international normalized ratio (INR)…
- Conditions
- Atrial Fibrillation, Venous Thromboses, Cardiac Valve Disease
- Trial name
- NCT03015025
- Testing
- Acenocoumarol
- Where
- Spain
- Volunteers
- 340 people
- Sponsor
- Instituto de Investigación Hospital Universitario La Paz
Aortic Valve Disease
Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)
The ASCEND post-market clinical follow-up study is undertaken to evaluate safety and clinical performance of the On-X Ascending Aortic Prosthesis (AAP) used in surgical aortic valve replacement.
- Trial name
- ASCEND (NCT05082454)
- Testing
- Open repair
- Where
- 11 sites in United States, Germany and 3 more
- Volunteers
- 108 people
- Sponsor
- JOTEC GmbH
Valvular Endocarditis
Surgical Management of Valvular Endocarditis
This study aims to achieve the following objectives objective 1 : To review the Investigators' experience of surgical management of infective endocarditis (IE) and analyze the outcomes and associated prognostic factors objective…
- Trial name
- NCT04572529
- Testing
- Cardiac Valve replacement
- Volunteers
- 50 people
- Sponsor
- Assiut University
Aortic Valve Stenosis, Implantation, Heart Valve Prosthesis
Supra-Annular vs. Annular ValvEs for Small Annuli
Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)
- Trial name
- SAVE (NCT04372381)
- Testing
- Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro
- Where
- 3 sites in United States
- Sponsor
- University of Arizona
Heart Valve Diseases, Heart; Complications, Valve, Prosthesis
Prevention of Renal Failure by Nitric Oxide in Prolonged Cardiopulmonary Bypass.
Prolonged periods of cardiopulmonary bypass (CPB) cause high levels of plasma free haemoglobin(Hb) and are associated with increased morbidity.
- Conditions
- Heart Valve Diseases, Heart; Complications, Valve, Prosthesis, Cardiac Valve Replacement Complication
- Trial name
- NCT01802619
- Testing
- inhaled nitric oxide, inhaled Nitrogen
- Where
- China
- Volunteers
- 217 people
- Sponsor
- Xijing Hospital
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 Valve Stenosis, Regurgitation, Aortic
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
The treatment with transcatheter aortic valve implantation (TAVI) of patients with small (≤23mm) surgical bioprostheses remains a challenge due to the increased transvalvular residual gradients and high rates of severe…
- Conditions
- Aortic Valve Stenosis, Regurgitation, Aortic, Prosthesis Failure
- Trial name
- NCT03520101
- Testing
- TAVI_ViV procedure with Edwards valve, TAVI_ViV procedure with CoreValve system
- Where
- Canada
- Volunteers
- 102 people
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Heart Valve Diseases
Heart Valve Prosthesis-Patient Mismatch
The purpose of this study is to determine the frequency of prosthesis-patient mismatch after mitral valve replacement and its effect on clinical outcomes.
- Trial name
- NCT00629902
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Florence Nightingale Hospital, Istanbul
Cardiac Anaesthesia
Registry of Cardio/Neurovascular Anesthesia Including the Database of Biological Signals During Anesthesia, Preoperative Assessment and Prognosis in Patients
The purpose of this study is to establish a registry database for patients undergoing anesthesia for cardiovascular surgery or procedures in our operating or hybrid room. The following information will be collected: 1.
- Trial name
- NCT04833751
- Where
- South Korea
- Volunteers
- 10,000 people
- Sponsor
- Yonsei University
Atrial Fibrillation, Deep Venous Thrombosis
Testing Strategies to Improving Warfarin Adherence
We are performing a research study to learn more about the control of an individual's blood thinning (anticoagulation) on warfarin.
- Conditions
- Atrial Fibrillation, Deep Venous Thrombosis, Dilated Cardiomyopathies
- Trial name
- NCT00622102
- Testing
- Lottery arm (Lottery and Med-eMonitor), Non-Lottery (Med-eMonitor only)
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- University of Pennsylvania
Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction
REVIVE-FR Registry
This registry aims to investigate treatment options for patients whose previously implanted biological aortic heart valve no longer functions properly.
- Conditions
- Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction, Structural Valve Deterioration, Prosthetic Heart Valve Thrombosis
- Trial name
- NCT07885761
- Testing
- TAVI-in-SAVR (Valve-in-Valve), THV-in-THV (Redo-TAVI), Surgical Explantation of a Failed Transcatheter Heart Valve
- Volunteers
- 200 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Thrombosis
Anticoagulation Regiments in Patients With Prosthetic Heart Valve Thrombosis
Prosthetic valve thrombosis is a serious complication with high mortality and morbidity. However, the best anticoagulant treatment strategies for patients with prosthetic heart valve thrombosis have not been fully known.
- Trial name
- NCT02240953
- Testing
- Warfarin, Warfarin + ASA 100 mg + PPI, Warfarin + ASA 300 mg + PPI
- Where
- Turkey (Türkiye)
- Volunteers
- 180 people
- Sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Atrial Fibrillations, Heart Valve Prostheses
What is the Optimal antiplatElet and Anticoagulant Therapy in Patients With Oral Anticoagulation Undergoing revasculariSaTion 2.
The optimal antithrombotic therapy for patients with atrial fibrillation (AF) with a CHA2DS2-VASc score ≥1 with concomitant acute coronary syndrome (ACS) or revascularisation by percutaneous coronary intervention (PCI) with…
- Conditions
- Atrial Fibrillations, Heart Valve Prostheses, Acute Coronary Syndromes, Coronary Artery Diseases
- Trial name
- WOEST 2 (NCT02635230)
- Testing
- Combination of chronic oral anticoagulation and a P2Y12 inhibitor with or without aspirin.
- Where
- 9 sites in Belgium, Netherlands
- Volunteers
- 2,200 people
- Sponsor
- R&D Cardiologie
Aortic Stenosis, Disorder of Prosthetic Cardiac Valve
Biomarkers in Aortic Stenosis - B.A.S.S.
This study is being done to determine whether or not new blood test(s) can determine the severity of heart conditions. Aortic stenosis, hypertrophic cardiomyopathy, mitral regurgitation, aortic regurgitation, artificial heart…
- Conditions
- Aortic Stenosis, Disorder of Prosthetic Cardiac Valve, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- BASS (NCT01334801)
- Testing
- Blood Draw
- Where
- United States
- Volunteers
- 378 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic