Clinical trials: Aortic Valve Disease
Aortic Valve Stenosis
TranScatheter Aortic Valve RepLacement System US Feasibility Trial
A study to assess the safety and effectiveness of the Direct Flow Medical aortic valve system. This is for people with severe aortic stenosis who are not well enough to undergo a surgical repair.
- Trial name
- SALUS (NCT01932099)
- Testing
- Transcatheter aortic valve replacement
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Direct Flow Medical, Inc.
Aortic Coarctation, Cardiomyopathy
Radiation-Free Heart Catheterization Using MRI
Currently catheters used in heart catheterization procedures are guided throughout the heart chambers and blood vessels by pictures taken by x-rays. This technology exposes patients to radiation.
- Conditions
- Aortic Coarctation, Cardiomyopathy, Atrial Septal Defect, Aortic Stenosis
- Trial name
- NCT02739087
- Testing
- MRI guided cardiac catheterization, Magnetic resonance imaging
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Joshua Kanter
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Biological Collection for the Purpose of Exploring Genetic and Clinical-biological Factors Associated With Variability in Response to Mavacamten in the Treatment of Obstructive Hypertrophic Cardiomyopathy
The European Medicines Agency has required pre-treatment genotyping of CYP2C19 to determine the initial and maximum dosage, in order to avoid overexposure to mavacamten associated with a decrease in ventricular ejection fraction…
- Trial name
- MAVA PG (NCT07439952)
- Where
- 3 sites in France
- Volunteers
- 300 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Stenoses, Aortic
SAfe and Fast Discharge With Acurate Valve in Low Risk tavI Patients
Recent evidence from scientific literature supported the extension of TAVI procedures to lower risk populations. Despite its widespread usage, the expansion of TAVI into lower risk patient populations is still limited by…
- Trial name
- SAFARI (NCT05983458)
- Testing
- Transaortic valve replacement
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Maria Cecilia Hospital
Aortic Stenosis Disease, TAVI(Transcatheter Aortic Valve Implantation)
Cerebral Regional Oxygen Saturation During TAVI - The CROS-TAVI Prospective Registry
This single-center, non-commercial clinical study investigates how different types of transcatheter aortic valve prostheses affect cerebral oxygen saturation during the procedure (TAVI - Transcatheter Aortic Valve Implantation).
- Conditions
- Aortic Stenosis Disease, TAVI(Transcatheter Aortic Valve Implantation), Cerebral Oxygen Saturation, Hemodynamic Changes
- Trial name
- CROS-TAVI (NCT07016789)
- Testing
- Near-infrared spectroscopy monitoring (NIRS) INVOS 5100C
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Aortic Valve Stenosis
Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome - (German Pilot)
Prospective, multicenter registry in patients undergoing commercially available balloon expandable valve implantation. The registry will consist of 3 phases: Prospective determination of baseline Status Quo (3 months)…
- Trial name
- Coordinate (NCT03570190)
- Testing
- Coordinator
- Where
- 3 sites in Germany
- Volunteers
- 161 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Aortic Valve Stenosis, Aortic Valve Insufficiency
Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population
This is a prospective, observational, single-arm, multi-center registry of patients undergoing bioprosthetic aortic valve replacement with the Avalus valve.
- Trial name
- Avalus (NCT05572710)
- Where
- 19 sites in Belgium, Denmark and 6 more
- Volunteers
- 1,000 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Aortic Stenosis, Aortic Valve Disease
Radial Versus Femoral Secondary Access During TAVI
The R-TAVI study is a randomized pilot study examining the use of the right radial artery versus the femoral artery for secondary vascular access during transcatheter aortic valve implantation (TAVI).
- Conditions
- Aortic Stenosis, Aortic Valve Disease, Vascular Access Complication
- Trial name
- R-TAVI (NCT03879824)
- Testing
- Secondary Radial Artery Access, Secondary Femoral Artery Access
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Carilion Clinic
Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation
Safety and Efficacy of Emergent TAVI in Patients With Severe AS
This is a single-centre, prospective, observational cohort study focusing on of patients suffering severe aortic valve stenosis (AS) undergoing emergent transcatheter aortic valve implantation (TAVI).
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Emergencies
- Trial name
- NCT05528211
- Volunteers
- 10 people
- Sponsor
- Qilu Hospital of Shandong University
Aortic Valve Stenosis, Aortic Valve Regurgitation
Hemodynamic Matched Comparison of the Balloon-Expandable Transcatheter Heart Valves Myval and Sapien-3 for the Treatment of Aortic Stenosis
Transcatheter aortic valve implantation (TAVI) is recommended for patients with severe aortic stenosis (AS) at high to intermediate surgical risk.
- Trial name
- MATCH-BALL (NCT04548726)
- Testing
- Sapien 3 Transcather Aortic Valve Implant, Myval Transcather Aortic Valve Implant
- Where
- 6 sites in Italy, Spain
- Volunteers
- 416 people
- Sponsor
- Ignacio J. Amat Santos
Aortic Root Aneurysm, Aortic Regurgitation
Aortic Valve-sparing Root Replacement, According to the Inclusion Technique Described by Tirone David
Retrospective observational study of all patients undergoing aortic root surgery with aortic valve conservation, using the inclusion technique described by Tirone David, between January 1, 2004 and December 31, 2020, at six…
- Trial name
- AORTLANTIC (NCT05515848)
- Testing
- No intervention
- Where
- 5 sites in France
- Volunteers
- 529 people
- Sponsor
- Nantes University Hospital
Aortic Valve Stenosis, Ventricular Dysfunction, Left
Ventriculo-arterial Coupling Modification Evaluated by PRAM During TAVI Procedure
Calcified aortic stenosis is the most frequent valvulopathy in Europe and North America. Aortic stenosis is an obstacle to the ejection of blood from the left ventricle to the aorta and leads to morphological changes in the left…
- Trial name
- PRAM-TAVI (NCT03385785)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Central Hospital, Nancy, France
Choreatic Disorder
Heart and Skeletal Muscle Problems in Neuroacanthocytosis
The purpose of this study is to learn about heart and skeletal muscle problems related to neuroacanthocytosis (also called Mcleod's syndrome and Levine-Critchley disease).
- Trial name
- NCT00007228
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Hypertrophic Cardiomyopathy, Endothelial Dysfunction
Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies
Left ventricular obstruction is an invalidating complication of hypertrophic cardiomyopathies (HCM), and endothelial dysfunction has also been observed in these pathologies.
- Trial name
- HCM-Vein (NCT04129905)
- Testing
- BNP blood sample test, Electrocardiogram, Holter ECG
- Where
- France
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University Hospital, Bordeaux
Aortic Valve Stenosis, Heart Valve Diseases
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease, Heart Disease Structural Disorder
- Trial name
- ENVISION (NCT05932615)
- Testing
- Navitor Transcatheter Aortic Valve Implantation (TAVI) System, Any Commercially Available Transcatheter Aortic Valve (CAV) System
- Where
- 107 sites in United States, Australia and 11 more
- Volunteers
- 1,500 people
- Sponsor
- Abbott Medical Devices
Severe Aortic Stenosis
SOURCE XT REGISTRY
This registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that…
- Trial name
- NCT01238497
- Testing
- TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
- Where
- 104 sites in Austria, Belgium and 16 more
- Volunteers
- 2,954 people
- Sponsor
- Edwards Lifesciences
Hypertrophic Cardiomyopathy
Study of Hypertrophic Cardiomyopathy Under Stress Conditions. Concordance Between Two Complementary Tests: Stress MRI and Exercice Stress Echocardiography
Hypertrophic cardiomyopathy (HCM) is a primitive myocardic disease and the first of genetic cardiac diseases. The definition of HCM is an increase of the myocardial thickness of the left ventricle (LV) wall without any other…
- Trial name
- CMHStress (NCT02500420)
- Testing
- Diagnosis examens
- Where
- France
- Volunteers
- 25 people
- Sponsor
- University Hospital, Montpellier
Aortic Valve Stenosis
Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the St. Jude Medical Transfemoral Delivery System
Collect and evaluate the long term safety data.
- Trial name
- NCT01497418
- Where
- 2 sites in Canada
- Volunteers
- 2 people
- Sponsor
- Abbott Medical Devices
HCM - Hypertrophic Cardiomyopathy, Mavacamten
Efficacy of Mavacamten in Patients With Symptomatic Latent Obstructive Hypertrophic Cardiomyopathy
This study aimed to evaluate the efficacy and safety of Mavacamten compared to no treatment in patients with symptomatic latent obstructive hypertrophic cardiomyopathy.
- Trial name
- NCT06947590
- Testing
- mavacamten
- Where
- China
- Volunteers
- 78 people
- Sponsor
- Xu Liu
Aortic Stenosis, Severe
The CardioFit Trial: Exercise Training Before Aortic Valve Surgery
The CardioFit Trial: The feasibility, safety and tolerability of an exercise training programme in patients with severe aortic stenosis prior to aortic valve replacement surgery: A feasibility trial To investigate if a Structured…
- Trial name
- CardioFit (NCT06818110)
- Testing
- Exercise
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
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