Clinical trials: Aortic Valve Disease
Aortic Stenosis
Medtronic CoreValve Evolut R U.S. Clinical Study
The study objectives are to assess the safety and efficacy of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis are considered at high or extreme risk…
- Trial name
- NCT02207569
- Testing
- CoreValve Evolut R TAVR system
- Where
- 23 sites in United States
- Volunteers
- 241 people
- Sponsor
- Medtronic Cardiovascular
Aortic Stenosis
Feasibility Study of the transShield Embolic Protection System
The objective of this study is to evaluate the initial safety and performance of the transShield EPS used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT06652841
- Testing
- transShield Embolic Protection System
- Where
- New Zealand
- Volunteers
- 2 people
- Sponsor
- TransAortic Medical, Inc.
Calcific Aortic Valve Disease, Inflammation
Impact of TAVI on the Gut Microbiota and Its Metabolites
Aortic stenosis is a common heart valve disease in older adults. It occurs when the aortic valve becomes narrowed, making it harder for blood to flow from the heart to the rest of the body.
- Conditions
- Calcific Aortic Valve Disease, Inflammation, Dysbiosis, TAVI
- Trial name
- Swiss-GUT-TAVI (NCT07565077)
- Where
- Switzerland
- Volunteers
- 40 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Irreversible Pulpitis, Reversible Pulpitis
In Vivo Pulp Thermal Changes During Different Slenderization Techniques
The goal of this study is to learn about the temperature rise inside the living part of a tooth (the pulp) during different ways of removing a small amount of enamel (the hard outer layer of the tooth), a procedure called…
- Conditions
- Irreversible Pulpitis, Reversible Pulpitis, Thermal Injury, Pulp Hyperemia
- Trial name
- IPR (NCT07391124)
- Testing
- High-Speed Air-Driven Drill (Airotor and Bur), Orthodontic IPR Kit (Oscillating System)
- Where
- Pakistan
- Volunteers
- 30 people
- Sponsor
- Armed Forces Institute of Dentistry, Pakistan
Cardiomyopathy, Hypertrophic, Physical Exercise
Effect of an Aerobic Exercise Session on Cardiovascular and Autonomic Parameters of Adults With Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy is a genetic heart disease with symptoms that may include dyspnea and fatigue predominantly on exertion, with or without chest pain, palpitations, syncope/presyncope and sudden cardiac death, mostly in…
- Conditions
- Cardiomyopathy, Hypertrophic, Physical Exercise, Autonomic Nervous System, Endothelium
- Trial name
- NCT07127640
- Testing
- Exercise
- Where
- Brazil
- Volunteers
- 10 people
- Sponsor
- Instituto de Cardiologia do Rio Grande do Sul
Aortic Regurgitation Disease
Aspirin Monotherapy Versus Sequential Warfarin-Aspirin Therapy After TAVR in Patients With Pure Aortic Regurgitation
This multicenter randomized controlled trial evaluates antithrombotic strategies post-TAVR in severe aortic regurgitation patients without long-term anticoagulation.
- Trial name
- AWATAR (NCT07677410)
- Testing
- Aspirin, Warfarin
- Where
- China
- Volunteers
- 1,172 people
- Sponsor
- Shanghai Zhongshan Hospital
Removal of Femoral Arterial Sheath in ICU Patients, Complete Hemostasis
Preliminary Exploration of Factors Affecting Complete Hemostasis and Supine Time After Removal of Femoral Arterial Sheath in ICU Patients
Background:Following cardiac catheterization and arterial sheath removal, manual compression is applied until bleeding stops, after which a compression belt is used.
- Conditions
- Removal of Femoral Arterial Sheath in ICU Patients, Complete Hemostasis, Coronary Artery Disease, Percutaneous Coronary Intervention
- Trial name
- NCT07469397
- Testing
- Direct Inspection, medical records browsing
- Where
- Taiwan
- Volunteers
- 157 people
- Sponsor
- National Taiwan University Hospital
Aortic Valve Stenosis
RESPOND EDGE Post Market Study
The purpose of the RESPOND EDGE post market study is to collect real world clinical and device performance outcomes data with the Lotus Edge™ Valve System used in routine clinical practice to demonstrate that the commercially…
- Trial name
- RESPOND EDGE (NCT04009720)
- Testing
- Lotus Edge Device
- Where
- 13 sites in Denmark, Finland and 7 more
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Stenosis
Valvosoft First-In-Man Study in Severe Symptomatic Aortic Stenosis
This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-man
- Trial name
- NCT03779620
- Testing
- Ultrasound treatment of Calcified aortic valve
- Where
- 2 sites in France, Netherlands
- Volunteers
- 30 people
- Sponsor
- Cardiawave SA
Aortic Valve Stenosis, Aortic Valve Calcification
REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm
This is a prospective, single-arm feasibility study designed to assess the acute safety and performance of the Lotus Valve System for transcatheter aortic valve replacement in symptomatic patients with calcified aortic valve…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve Disease
- Trial name
- REPRISE I (NCT01383720)
- Testing
- Lotus Valve System
- Where
- 3 sites in Australia
- Volunteers
- 11 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Stenosis, Multidetector Computed Tomography
The Aortic Valve DECalcification (AVADEC) Trial
Aortic stenosis is a common heart valve disease and due to the growing elderly population the prevalence is increasing. The disease is progressive with increasing calcification of the valve cusps.
- Conditions
- Aortic Valve Stenosis, Multidetector Computed Tomography, Vitamin K 2, Randomised Clinical Trial
- Trial name
- AVADEC (NCT03243890)
- Testing
- Menaquinone-7 720 µg/day including the recommended daily dose of vitamin D (25 µg/day).
- Where
- Denmark
- Volunteers
- 389 people
- Sponsor
- Axel Diederichsen
Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Neurologic Evaluation
Neurologic Evaluation of Patients After Transapical Beating-Heart Septal Myectomy
The goal of this prospective cohort study is to evaluate the neurologic changes in patients that received transapical beating-heart septal myectomy.
- Conditions
- Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Neurologic Evaluation, Magnetic Resonance Imaging \(MRI\), Transapical Beating-Heart Septal Myectomy
- Trial name
- NCT06078410
- Testing
- Cardiac surgery
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Xiang Wei
Aortic Valve Stenosis, Heart Failure
Conventional Versus Left Bundle Branch Pacing in TAVI
This randomized study compares the effects of conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF < 40 %) versus left bundle branch pacing on left…
- Conditions
- Aortic Valve Stenosis, Heart Failure, Pacemaker-Induced Cardiomyopathy, Transcatheter Aortic Valve Implantation
- Trial name
- NCT05895097
- Testing
- Left bundle branch pacemaker, Conventional pacing
- Where
- Slovenia
- Volunteers
- 50 people
- Sponsor
- University Medical Centre Ljubljana
Aortic Valve Disease
4D- Flow- MRI After Aortic Valve Surgery
This randomized controlled trial was designed to analyze flow patterns in the ascending aorta with MRI after either Trileaflet reconstruction of the aortic valve with autologous pericardium (TriRec) or surgical valve replacement…
- Trial name
- NCT04223713
- Testing
- TriRec, Aortic valve replacement
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE Study
The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.
- Trial name
- CADENCE (NCT02688153)
- Testing
- EDWARDS INTUITY, Stented aortic bioprostheses
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Edwards Lifesciences
Hypertrophic Cardiomyopathy
VIZ ACCESS HCM - Multi-Site Registry
To describe the clinical, economic, and population characteristics of newly diagnosed, previously diagnosed, and suspected patients evaluated by Viz HCM.
- Trial name
- NCT07103057
- Testing
- Viz HCM
- Where
- 3 sites in United States
- Volunteers
- 17 people
- Sponsor
- Viz.ai, Inc.
Aortic Valve Stenosis
SAPIEN 3 Ultra System PMCF
A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
- Trial name
- NCT04555967
- Testing
- SAPIEN 3 Ultra System
- Where
- 11 sites in Austria, Canada and 6 more
- Volunteers
- 200 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis, Aortic Insufficiency
CardioCel Tri-leaflet Repair Study
This study will quantify the safety and efficacy of the CardioCel implant in tri-leaflet repair. 80 patients in up to 7 sites in Europe and the US will all be treated with the CardioCel implant.
- Trial name
- CTRS (NCT02629328)
- Testing
- CardioCel
- Where
- Belgium
- Volunteers
- 28 people
- Sponsor
- Anteris Technologies Ltd.
Coronary Artery Disease, Aortic Valve Disorder
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX
The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures…
- Conditions
- Coronary Artery Disease, Aortic Valve Disorder, Heart Failure, Aortic Valve Stenosis
- Trial name
- NCT01171625
- Testing
- Implantation of CEP Magna Ease Model 3300TFX
- Where
- 13 sites in United States, Austria and 4 more
- Volunteers
- 283 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Heart Valve Disease
Valve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves
A single-center prospective interventional trial. Patients implanted with a sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012 will be eligible.
- Trial name
- NCT02671474
- Testing
- 4-dimensional volume-rendered computed tomography
- Where
- Sweden
- Volunteers
- 47 people
- Sponsor
- Karolinska University Hospital
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