Clinical trials: Aortic Valve Disease
Aortic Insufficiency
The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance
This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D…
- Trial name
- NCT01732835
- Testing
- HAART 300 Annuloplasty Device
- Where
- 8 sites in Czechia, Germany
- Volunteers
- 68 people
- Sponsor
- Biostable Science & Engineering
Hypertrophic Cardiomyopathy (HCM), Atrial Fibrillation (AF)
Mechanisms of Atrial Pathoelectrophysiology in HCM
This study aims to learn why atrial fibrillation (AF), a type of irregular heartbeat, happens more often and is harder to treat in people with hypertrophic cardiomyopathy (HCM).
- Trial name
- MAP HCM (NCT07454135)
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Aortic Regurgitation, Aortic Valve Insufficiency
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System compared with surgical aortic valve replacement (SAVR) for treatment of subjects with clinically significant native aortic regurgitation (AR)
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency
- Trial name
- ARTIST (NCT06608823)
- Testing
- Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System, SAVR
- Where
- 40 sites in United States
- Volunteers
- 1,016 people
- Sponsor
- JenaValve Technology, Inc.
Aortic Valve Disease
Neurocognitive Assessment in TAVI
Severe aortic stenosis is a common heart condition affecting elderly patients. Degeneration of the aortic valve (oneway valve between the heart and the aorta) causes high resistence to blood flow, resulting in strain on the heart…
- Trial name
- NEAT TAVI (NCT06120946)
- Where
- United Kingdom
- Volunteers
- 120 people
- Sponsor
- Brighton and Sussex University Hospitals NHS Trust
Aortic Valve Stenosis, Aortic Valve Calcification
Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis
1. objectives Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by femoral artery Evaluate safety and clinical benefit of percutaneous implantation of the Venue MedTech aortic valve prosthesis.
- Trial name
- Venus-A (NCT01683474)
- Testing
- Venus MedTech Aortic Valve Prosthesis
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
Severe Aortic Valve Stenosis
VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease
This prospective, randomized-controlled multicenter study investigates whether virtual reality-assisted patient education in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) can improve patient…
- Trial name
- VRAP-Heart (NCT05552352)
- Testing
- Virtual Reality assisted information
- Where
- 2 sites in Germany
- Volunteers
- 300 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Aortic Stenosis, Aortic Valve Disease
Role of Aortic Valve Composition in Pathophysiology and Diagnosis of Aortic Stenosis
The study aims to evaluate composition differences of aortic valves in different stages and phenotypes of aortic stenosis using non-invasive imaging and histology.
- Conditions
- Aortic Stenosis, Aortic Valve Disease, Aortic Valve Calcification
- Trial name
- COMP-AS (NCT06136689)
- Where
- 2 sites in Poland
- Volunteers
- 55 people
- Sponsor
- Medical University of Warsaw
Aortic Valve Disease
DIrect Oral Anticoagulation and Bioprothesis Aortic Valve
DIAMOND study is a national, multicentre, randomized, parallel-group, open label study in patients (aged ≥18 years) with aortic bioprosthesis (excluding TAVI) at least 7 days after cardiac surgery.
- Trial name
- DIAMOND (NCT05687448)
- Testing
- Apixaban 5 MG Oral Tablet, Aspirin 75 to 100mg once a day
- Where
- France
- Volunteers
- 1,500 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Elite Valve System
The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a…
- Trial name
- MISSION (NCT02907463)
- Where
- 23 sites in Austria, Denmark and 7 more
- Volunteers
- 280 people
- Sponsor
- Edwards Lifesciences
Hypertrophic Cardiomyopathy, Mechanical Hyper-synchronicity
Hyper-synchronicity in Hypertrophic Cardiomyopathy (HCM) : Description, Mechanism and Origin With a Multi-imaging Approach to Predict Dual Chamber Pacing Response
Hypertrophic cardiomyopathy (HCM) is a common genetic cardiovascular disease. Outflow-tract gradient of 30 mmHg or more under resting conditions is an independent determinant of symptoms of progressive heart failure and death.
- Trial name
- HSYNC (NCT02559726)
- Testing
- Echocardiography (TEE), Magnetic resonance imaging (MRI) with gadolinium enhancement, Magnetic resonance imaging (MRI) without gadolinium enhancement
- Where
- France
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University Hospital, Bordeaux
Aortic Valve Stenosis
Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the VitaFlow Liberty® Flex Transcatheter Aortic Valve Delivery System for the Treatment of Severe Aortic Stenosis Lesions
This is a prospective, multicenter, randomized controlled clinical study designed to evaluate the real-world performance of the VitaFlow Liberty® Flex Transcatheter Aortic Valve Retrievable and Steerable Delivery System…
- Trial name
- Flex-TAVR (NCT07145463)
- Testing
- Transcatheter Aortic Valve Replacement
- Where
- China
- Volunteers
- 232 people
- Sponsor
- Shanghai Zhongshan Hospital
Aortic Valve Stenosis, Heart Valve Diseases
Antagonization of Heparin With Protamine Sulfate After TAVI
Transcatheter aortic valve replacement (TAVR) is now the first therapeutic option offered to high and intermediate risk patients with symptomatic aortic stenosis but even to low-risk, when the aortic valve is tricuspid and the…
- Trial name
- ATLANTIS-Prota (NCT06215378)
- Testing
- Antagonization of heparin with protamine sulfate
- Where
- France
- Volunteers
- 940 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Aortic Valve Stenosis
Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis: FinnValve Registry
The FinnValve investigators planned a nationwide registry to investigate the early and late outcome of transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve replacement (SAVR) in patients with aortic…
- Trial name
- FinnValve (NCT03385915)
- Testing
- Aortic valve replacement
- Where
- Finland
- Volunteers
- 6,463 people
- Sponsor
- Turku University Hospital
Aortic Stenosis, Aortic Valve Stenosis
SAPIEN 3 Ultra EU PMS
This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating…
- Trial name
- NCT04860752
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 37 sites in Austria, Finland and 8 more
- Volunteers
- 500 people
- Sponsor
- Edwards Lifesciences
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 Regurgitation Disease, Aortic Valve Calcification
Valvular Assessment of New Generation Aortic Replacement Devices
The VANGUARD study is an open-label, prospective, randomized trial comparing the long-term outcomes of two advanced bioprosthetic aortic valves, Dafodil® and INSPIRIS Resilia®, in patients undergoing aortic valve replacement…
- Conditions
- Aortic Regurgitation Disease, Aortic Valve Calcification, Bicuspid Aortic Valve Disease
- Trial name
- VANGUARD (NCT06688448)
- Testing
- Dafodil prosthesis, Aortic Valve Replacement - Inspires Resilia prosthesis
- Where
- Brazil
- Volunteers
- 200 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
Severe Aortic Valve Stenosis
Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China
The purpose of this study was to observe the safety and effectiveness of transcatheter aortic valve replacement in patients with aortic valve stenosis in a real-world clinical practice environment.
- Trial name
- NCT04988243
- Testing
- All aortic valve products on the market
- Volunteers
- 320 people
- Sponsor
- CCRF Inc., Beijing, China
Gingival Recession, Lack of Keratinized Gingiva (Disorder)
Progenitor Potential of Mesenchymal Stem Cells in Palatal Tissue Harvested From Molar and Premolar Sites
The primary purpose of this protocol is to isolate, investigate and compare the regenerative and differentiation potential of mesenchymal stem cells (MSC's) in the gingival (gum) tissue harvested from two different locations from…
- Trial name
- NCT03570333
- Testing
- progenitor potential of Gingival Mesenchymal cells
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Bicuspid Aortic Valve
The CASPER Registry
The CASPER study is a prospective, international, multicenter registry which aims to evaluate the use of an algorithm for choosing the size of the prosthesis to be implanted in patients with bicuspid aortic stenosis type I…
- Trial name
- NCT04817735
- Testing
- TAVI
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- University of Pisa
Hypercholesterolemia, Atherosclerosis
Dietary Phytosterols and Human Aortic Valve
This randomized controlled double-blind intervention study unravels influence of dietary plant sterols and stanols on the structure and the sterol composition of the human aortic valve.
- Trial name
- NCT00738933
- Testing
- Dietary plant stanols, Dietary plant sterols
- Where
- Finland
- Volunteers
- 60 people
- Sponsor
- University of Helsinki
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