Clinical trials: Valve Disease, Aortic
Aortic Stenosis
Role of Active Valvular Calcification and Inflammation in Patients With Aortic Stenosis
The aortic valve is the main outlet valve from the heart. This valve can become diseased and narrowed when it needs to be replaced with an artificial valve.
- Trial name
- NCT01358513
- Where
- United Kingdom
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- University of Edinburgh
Aortic Stenosis, Valvular Cardiomyopathy
Feasibility of 3D Printed Models of Aortic Stenosis in Guiding TAVI Procedure
The aim of 3DP-FAST study is to analyze the accuracy of replicating cardiovascular anatomical structures using different techniques and to evaluate the feasibility of 3D printed models of aortic stenosis in guiding TAVI…
- Conditions
- Aortic Stenosis, Valvular Cardiomyopathy, Aortic Valve Disease
- Trial name
- 3DP-FAST (NCT05484713)
- Testing
- Cardiac imaging, 3D printing of the aortic valve
- Where
- Romania
- Volunteers
- 20 people
- Sponsor
- Cardio Med Medical Center
Aortic Valve Stenosis, Aortic Valve Regurgitation
TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease
To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).
- Conditions
- Aortic Valve Stenosis, Aortic Valve Regurgitation, Aortic Valve Stenosis With Insufficiency, Constriction, Pathologic
- Trial name
- TAVIS (NCT05536310)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 3 sites in Germany
- Volunteers
- 24 people
- Sponsor
- JenaValve Technology, Inc.
Coronary Artery Stenosis, Transcatheter Aortic Valve Implantation
Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis
The purpose of the current study is to assess complete coronary physiology (FFR, RFR, CFR, IMR, and CT-FFR) in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI.
- Trial name
- CHOICE-FR (NCT05133843)
- Testing
- Assession of complete coronary physiology
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Helios Health Institute GmbH
Severe Aortic Stenosis
Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted very high risk and high risk for aortic…
- Trial name
- NCT01531374
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 45 sites in United States
- Volunteers
- 2,777 people
- Sponsor
- Medtronic Cardiovascular
Valvular Heart Disease
The PROTEMBO C Trial
The PROTEMBO C Trial is an international, multi-center, single arm, non-inferiority study of the safety and performance of using the ProtEmbo System for cerebral embolic protection in subjects with severe native aortic valve…
- Trial name
- NCT04618718
- Testing
- cerebral embolic protection during TAVR
- Where
- 8 sites in Germany, Latvia and 1 more
- Volunteers
- 64 people
- Sponsor
- Protembis GmbH
Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement
The objective of this trial is to assess the safety and effectiveness of the Edwards Pericardial Aortic Bioprosthesis Model 11000A, in the pulmonary position in pediatric and adult subjects five years or older requiring…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration, Congenital Pulmonary Valve Abnormality
- Trial name
- COMMENCE-P (NCT02656290)
- Testing
- Edwards Pericardial Aortic Bioprosthesis Model 11000A
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Obstructive Hypertrophic Cardiomyopathy
A Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy
The study is being conducted to evaluate the efficacy, and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy
- Trial name
- NCT06516068
- Testing
- HRS-1893
- Where
- China
- Volunteers
- 42 people
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Acute Kidney Injury
Prevention of Acute Kidney Injury After Transcatheter Aortic Valve Implantation
Randomized controlled, single-center trial randomizing patients with chronic kidney disease and symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI).
- Trial name
- NCT04537325
- Testing
- RenalGuard system
- Where
- Germany
- Volunteers
- 98 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Aortic Valve Stenosis, Ventricular Hypertrophy
Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis
The purpose of the study is to see if statin therapy will optimize myocardial response to cardiopulmonary bypass during aortic valve replacement (AVR) for aortic valve stenosis (AVS) (Phase I) and optimize left ventricular…
- Trial name
- NCT00811330
- Testing
- Atorvastatin 80 mg
- Where
- France
- Volunteers
- 60 people
- Sponsor
- University Hospital, Strasbourg, France
Delirium, Post-Op Complication
Impact of Anesthesia Technique on Post-operative Delirium After Transcatheter Aortic Valve Implantation
Aortic stenosis is a frequent valvulopathy in Europe and North America. It occurs mainly over 65 years (2-7% of the population over 65 years). Treatment of symptomatic stenosis is an indication of aortic valve replacement.
- Conditions
- Delirium, Post-Op Complication, Anesthesia, Aortic Valve Disease
- Trial name
- DELIRIUMTAVI (NCT03323619)
- Testing
- anesthesia type
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Central Hospital, Nancy, France
Cardiomyopathy, Hypertrophic, Cardiomyopathy, Dilated
National Network for Cardiovascular Genomics: Advancing Cardiovascular Healthcare for Hereditary Diseases in Brazil's Unified Health System Through a Multicenter Registry
The goal of this observational study is to develop a registry of Brazilian patients with hereditary cardiovascular diseases, combining clinical and genomic data.
- Conditions
- Cardiomyopathy, Hypertrophic, Cardiomyopathy, Dilated, Cardiomyopathy Restrictive, Arrhythmogenic Right Ventricular Dysplasia
- Trial name
- RENOMICA-Hcor (NCT06546137)
- Testing
- whole genome sequencing
- Where
- 27 sites in Brazil
- Volunteers
- 1,211 people
- Sponsor
- Hospital do Coracao
Heart Disease, Coronary Artery Disease
Bleeding Prediction in Patients Following Cardiac Surgery Using Whole Blood Aggregometry and Thromboelastometry
Use of whole blood impedance aggregometry and rotational thromboelastometry can reveal useful data about platelet function and viscoelastic properties of blood clot in patients undergoing cardiac surgery.
- Conditions
- Heart Disease, Coronary Artery Disease, Aortic Valve Disease, Mitral Valve Disease
- Trial name
- NCT01281397
- Where
- Croatia
- Volunteers
- 148 people
- Sponsor
- University of Zagreb
Glutathione Peroxidase Activity, Aortic Stenosis
GPx Activity in Subjects With Aortic Stenosis Undergoing TAVR
The aim of this project is to investigate the association of glutathione peroxidase (GPx) and severe aortic stenosis (AS), as well as the impact of transcatheter aortic valve replacement (TAVR) on GPx activity post-procedure.
- Conditions
- Glutathione Peroxidase Activity, Aortic Stenosis, Transcatheter Aortic Valve Replacement
- Trial name
- NCT04268160
- Testing
- Blood draw to measure GPx activity, Blood draw to measure SOD activity, Blood draw to measure Lp(a) levels
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Florida
Aortic Valve Disease, Mitral Valve Disease
Artificial Valve Endocarditis Reduction Trial
The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).
- Conditions
- Aortic Valve Disease, Mitral Valve Disease, Endocarditis
- Trial name
- AVERT (NCT00590889)
- Testing
- Artificial Mechanical Heart Valve
- Where
- 16 sites in United States, Canada and 6 more
- Volunteers
- 807 people
- Sponsor
- Abbott Medical Devices
Cardiovascular Diseases
SAVR: IMPACT of Pre-existing Comorbidities on Patient Outcomes and Prosthetic Valve Performance in a Real-world Setting.
The IMPACT Registry represents a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years that includes data of patients undergoing aortic valve replacement with the Edwards…
- Trial name
- IMPACT (NCT04053088)
- Testing
- INSPIRIS RESILIA Aortic Valve™
- Where
- 22 sites in Austria, Germany and 2 more
- Volunteers
- 500 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Degenerative Aortic Valve Disease
REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)
The overall hypothesis is that redo aortic valve replacement (rAVR) is superior to valve-invalve transcatheter aortic valve replacement (ViV-TAVR) for the composite endpoint of freedom from all-cause mortality, all-cause stroke…
- Trial name
- REPEAT (NCT07462624)
- Testing
- Transfemoral transcatheter valve-in-valve implantation, Surgical redo aortic valve replacement
- Where
- Germany
- Volunteers
- 890 people
- Sponsor
- Heart Center Leipzig - University Hospital
Hypertrophic Cardiomyopathy (HCM), Dilated Cardiomyopathy (DCM)
Early Identification and Treatment of Rare Cardiomyopathy Cohorts
This study aims to further develop an imaging-guided cohort of rare cardiomyopathies based on the existing database. The investigators will standardize the construction of a cohort that integrates a clinical data repository…
- Conditions
- Hypertrophic Cardiomyopathy (HCM), Dilated Cardiomyopathy (DCM), Metabolic Cardiomyopathy, Restrictive Cardiomyopathy
- Trial name
- EARLY-MYO-RARE (NCT06794710)
- Testing
- diuretics, ACEIs/ARBs, beta blockers, positive inotropic drugs, MRAs, SGLT2i, retinoids, Close follow-up, early rehabilitation guidance
- Where
- China
- Volunteers
- 300 people
- Sponsor
- RenJi Hospital
Severe Aortic Valve Stenosis, Anxiety
Virtual Reality Assisted Conscious Sedation During TAVI
Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic valve stenosis. Pain and anxiety are major contributors to procedural complications.
- Conditions
- Severe Aortic Valve Stenosis, Anxiety, Pain
- Trial name
- TAVI_VR (NCT04259723)
- Testing
- VR during TAVI
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
Aortic Valve Stenosis
The Leaflex™ Brazilian Standalone Study
A prospective, multicenter, single-arm study aimed to demonstrate safety and performance of the Leaflex™ Performer in the treatment of symptomatic severe aortic stenosis.
- Trial name
- NCT05052684
- Testing
- Leaflex™ Performer
- Where
- Brazil
- Volunteers
- 1 people
- Sponsor
- Pi-cardia
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