Clinical trials: Prosthetic Heart Valve
Symptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative…
- Trial name
- NCT03752866
- Testing
- Portico™ Valve, Portico Delivery System(s) and Loading System(s), Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)
- Where
- 28 sites in Australia, Belgium and 7 more
- Volunteers
- 1,001 people
- Sponsor
- Abbott Medical Devices
Sacubitril/Valsartan, Prosthetic Heart Valve
Sacubitril/Valsartan in Patients With Prosthetic Heart Valves With Heart Failure and Reduced Ejection Fraction
This study aims to evaluate the effect of sacubitril/valsartan in patients with prosthetic heart valves with heart failure with reduced ejection fraction (HFrEF).
- Conditions
- Sacubitril/Valsartan, Prosthetic Heart Valve, Heart Failure, Reduced Ejection Fraction
- Trial name
- NCT07192341
- Testing
- Sacubitril/Valsartan, Conventional anti-heart failure therapy
- Where
- Egypt
- Volunteers
- 220 people
- Sponsor
- Kafrelsheikh University
AORTIC VALVE DISEASES, Aortic Valve Stenosis
Clinical Investigation for the PoliaValve Aortic Heart Valve- India
The purpose of this study is to conduct a clinical investigation of the HeartHill PoliaValve Aortic Valve to collect evidence on the device's safety and performance.
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis, Aortic Valve Regurgitation
- Trial name
- NCT07123766
- Testing
- PoliaValve (Aortic)
- Volunteers
- 50 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Aortic Valve Disease, Aortic Valve Stenosis
Evaluation of the Inflammatory Response in Post-operated Aortic Valve Replacement Patients.
Background Calcification of the aortic valve affects more than 26% of adult patients over 65 years of age and is the main indication for valve replacement in the United States of America.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification, Prosthetic Valve Malfunction
- Trial name
- NCT04557345
- Testing
- Determination of cytokines, Two-dimensional transthoracic echocardiogram
- Where
- Mexico
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
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
Aortic Valve Stenosis
5 Year Observation of Patients With PORTICO Valves
The purpose of this clinical investigation is to further assess the performance and safety profile of the commercially-available Portico™ TAVI System in patients with severe symptomatic aortic stenosis.
- Trial name
- PORTICO-1 (NCT01802788)
- Testing
- St Jude Medical Portico replacement aortic valve, Transcatheter Aortic Valve Implant
- Where
- 60 sites in Australia, Belgium and 11 more
- Volunteers
- 1,032 people
- Sponsor
- Abbott Medical Devices
Left-sided Prosthetic Heart Valve Thrombosis
Surgery Versus Fibrinolytic Therapy for Left-sided Prosthetic Heart Valve Thrombosis
Malfunction of mechanical heart valves due to clot formation is a potentially devastating complication. It often results in heart failure, death or stroke.
- Trial name
- SAFE-PVT (NCT01641549)
- Testing
- Emergency surgery, Fibrinolytic therapy
- Where
- India
- Volunteers
- 115 people
- Sponsor
- All India Institute of Medical Sciences
Heart Valve Diseases
Dabigatran Etexilate in Patients With Mechanical Heart Valves
To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.
- Trial name
- RE-ALIGN (NCT01452347)
- Testing
- warfarin 1mg, dabigatran etexilate intermediate dose, dabigatran etexilate low dose
- Where
- 40 sites in Belgium, Canada and 8 more
- Volunteers
- 328 people
- Sponsor
- Boehringer Ingelheim
Anti-coagulation Therapy, DVT
Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
The WARFARIN Study is a clinical trial designed to determine if the use of genetic information related to warfarin sensitivity can help create a dose of warfarin that will result in less hospitalizations and deaths related to…
- Conditions
- Anti-coagulation Therapy, DVT, Pulmonary Embolism, Joint Surgery Multiple
- Trial name
- WARFARIN (NCT01305148)
- Testing
- Warfarin GenoSTAT Test
- Where
- 56 sites in United States
- Volunteers
- 3,800 people
- Sponsor
- Iverson Genetic Diagnostics, Inc.
Severe Mitral Valve Regurgitation, Severe Mitral Valve Stenosis
The Feasibility Study of Polymer Artificial Heart Valve for the Treatment the Mitral Valve Disease.
The study aims to evaluate the feasibility and safety of polymer artificial heart valve designed and developed by Shanghai HeartEpoch Medical technology Co. Ltd. for the treatment of the mitral valve diseases.
- Trial name
- HeartEpoch (NCT07243184)
- Testing
- mitral valve replacement
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Shanghai HeartEpoch Medical Technology Co., Ltd
Endocarditis
Interest of Parametric Positron Emission Imaging in the Diagnosis of Infections on Cardiac Valve Prosthesis
The objective of this study is to determine if early parametric positron emission computed tomography is useful to diagnose cardiac prosthetic valve infections.
- Trial name
- PARAVA (NCT05146180)
- Testing
- Parametric positron emission computed tomography
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Centre Henri Becquerel
Heart Valve Prosthesis
Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve
The goal of this retrospective chart review is to contribute to the literature on the mid-term durability and hemodynamics of the INSPIRS Resilia bioprosthesis when implanted in children and young adults.
- Trial name
- NCT05986396
- Testing
- INSPIRIS Resilia (model 11500A)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Baylor College of Medicine
Mycobacterium Chimaera Infections
Prosthetic Valve and Graft Endocarditis With Mycobacterium Chimaera
Mycobacterium chimaera infections have occurred in post-cardiac surgery patients in association with contaminated cardiac bypass heater-cooler devices. So far optimal therapeutical concepts are not clear.
- Trial name
- NCT04429256
- Testing
- data collection
- Where
- Switzerland
- Volunteers
- 7 people
- Sponsor
- University Hospital, Basel, Switzerland
Atrial Fibrillation, Venous Thromboembolism
Prothrombin Times Outside the Therapeutic Range in Otherwise Stable Patients
Warfarin is very effective for the prevention of blood clots (thrombosis). A test of coagulation, the prothrombin time (PT) is used to monitor the effect.
- Conditions
- Atrial Fibrillation, Venous Thromboembolism, Ischemic Stroke, Myocardial Infarction
- Trial name
- FORESPEAK-0 (NCT00814177)
- Testing
- warfarin
- Where
- Canada
- Volunteers
- 160 people
- Sponsor
- Hamilton Health Sciences Corporation
Heart Valve Stenosis
ADVANTAGE® Prosthetic Heart Valve Long-term Follow-up Trial
The objective of this study is to assess long term safety and durability of the Advantage prosthetic heart valve.
- Trial name
- NCT01264484
- Testing
- Advantage Prosthetic Heart Valve
- Where
- 2 sites in Germany
- Volunteers
- 212 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Prosthetic Valve Endocarditis
Evolution of PET Fixation With FDG at the End of Antibiotic Treatment of Infective Endocarditis on Valvular Prosthesis
In patients with prosthetic valve endocarditis (PVE) and pathological valvular FDG uptake on the initial FDG-PET and not referred to valve replacement at the acute phase, the study will assess whether FDG-PET is able to identify…
- Trial name
- EndEOTEP (NCT05989152)
- Testing
- FDG-PET at the end of treatment for IE
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Anticoagulants Causing Adverse Effects in Therapeutic Use, Patient Compliance
Social-software iMproving wARfarin Therapy
Poor anticoagulation quality is a major problem among Chinese patients receiving warfarin therapy in traditional health care settings. Improving warfarin therapy has been crucial for Chinese patients.
- Trial name
- SMART (NCT03264937)
- Testing
- Social-software management
- Where
- China
- Volunteers
- 735 people
- Sponsor
- Wuhan Asia Heart Hospital
Aortic Valve Insufficiency
Results of the Aortic Valve Reconstruction in Children
Aortic valve disease counts up to 5% of cases of congenital heart disease being one of the most common congenital malformations of the cardiovascular system.
- Trial name
- NCT04162444
- Testing
- Physical examination, The Ross Classification for Heart Failure in Children, The Aristotle score
- Where
- Russia
- Volunteers
- 40 people
- Sponsor
- National Medical Research Center for Children's Health, Russian Federation
Prosthetic Cardiac Valve Thrombosis, Cerebrovascular Accident
Rule Out Transcatheter Aortic Valve Thrombosis With Post Implantation Computed Tomography (RETORIC)
The RETORIC study is a prospective cohort study with a primary aim to assess the incidence and independent predictors of reduced leaflet motion and valve thrombosis after TAVI procedure using multimodality imaging strategy…
- Conditions
- Prosthetic Cardiac Valve Thrombosis, Cerebrovascular Accident, Prosthetic Valve Malfunction
- Trial name
- RETORIC (NCT02826200)
- Testing
- Acenocoumarol, Standard of care
- Where
- Hungary
- Volunteers
- 200 people
- Sponsor
- Semmelweis University Heart and Vascular Center
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