Clinical trials: Stenosis, Aortic
Aortic Stenosis
Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic aortic stenosis underdoing a Transcatheter Aortic Valve replacement…
- Trial name
- NCT05866640
- Testing
- F2 filter and delivery system
- Where
- Georgia
- Volunteers
- 31 people
- Sponsor
- EnCompass Technologies, Inc.
Aortic Stenosis
Aortic Stenosis Evaluated Via Modern Ballistocardiography and Seismocardiography
Calcific aortic stenosis (AS) (formerly "senile" or "degenerative") is a frequent disease of heart valves and is characterized by a thickness and calcification of leaflets with a significant increase of the pressure gradient…
- Trial name
- TAVI (NCT04231201)
- Where
- Belgium
- Volunteers
- 135 people
- Sponsor
- Erasme University Hospital
Aortic Stenosis, Disorder of Prosthetic Cardiac Valve
Biomarkers in Aortic Stenosis - B.A.S.S.
This study is being done to determine whether or not new blood test(s) can determine the severity of heart conditions. Aortic stenosis, hypertrophic cardiomyopathy, mitral regurgitation, aortic regurgitation, artificial heart…
- Conditions
- Aortic Stenosis, Disorder of Prosthetic Cardiac Valve, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- BASS (NCT01334801)
- Testing
- Blood Draw
- Where
- United States
- Volunteers
- 378 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Aortic Stenosis, Severe
MRI in Randomised Cohorts of Asymptomatic AS
Aortic stenosis is narrowing of the aortic valve, and is the commonest type of valve disease requiring surgery. Current guidelines recommend waiting till patients develop symptoms (chest pain, breathlessness and dizzy…
- Trial name
- NCT05178368
- Testing
- Surgical/ Transcatheter aortic valve replacement
- Where
- United Kingdom
- Volunteers
- 202 people
- Sponsor
- University of Leicester
Hypertrophic Cardiomyopathy (HCM), Heart Failure
Retrospective Natural History Study of RASopathy-associated Cardiomyopathy (RAS-CM)
RASopathy-associated hypertrophic cardiomyopathy (RAS-CM) is a disease with high morbidity and high mortality if presenting during infancy.
- Conditions
- Hypertrophic Cardiomyopathy (HCM), Heart Failure, RASopathy
- Trial name
- RAS-CM (NCT07344480)
- Testing
- Retrospective data collection
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Aortic Stenosis, Valvular Heart Disease
ADVANCE Direct Aortic Study
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve…
- Trial name
- NCT01676727
- Testing
- CoreValve aortic valve
- Where
- 9 sites in Czechia, France and 4 more
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Severe Aortic Stenosis, Iron-deficiency
Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis
Iron deficiency is a prevalent nutritional deficiency and a common cause of anemia. Although iron deficiency is traditionally linked to anemia, iron deficiency is prevalent even in the absence of anaemia and in itself limits…
- Trial name
- IIISAS (NCT04206228)
- Testing
- Intravenous iron isomaltoside
- Where
- Norway
- Volunteers
- 149 people
- Sponsor
- Oslo University Hospital
Aortic Valve Stenosis
The Leipzig TAVI Registry
A single-center registry including all patients treated with TAVI at the Heart Center, Leipzig, Germany
- Trial name
- NCT05015452
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- Germany
- Volunteers
- 20,000 people
- Sponsor
- Helios Health Institute GmbH
Coronary Artery Disease, Aortic Stenosis
Aortic Valve and Root Measurements Under Real-Time 3-Dimensional Visualization During Angiography
The American College of Cardiology/American Heart Association guidelines place symptomatic severe Aortic Stenosis as a class I indication for aortic valve replacement.
- Trial name
- NCT02073617
- Testing
- Real-time 3-dimensional DynaCT
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- NYU Langone Health
Aortic Valve Stenosis
Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation With Balloon-expandable Valves Versus Self-expandable Valves.
The aim of this collaborative analysis is to evaluate stroke rates and mortality in patients undergoing TAVI with the self-expandable MCV prosthesis compared to the balloon-expandable ES valve.
- Trial name
- CENTER (NCT03588247)
- Testing
- transcatheter aortic valve implantation
- Where
- Netherlands
- Volunteers
- 12,000 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Aortic Valve Stenosis, Lipoprotein(a)
Lipoprotein(a) and Progression of Aortic Stenosis
This study is a prospective, observational, two arm parallel group, clinical study involving patients with measurements of Lp(a) and mild to moderate aortic stenosis.
- Trial name
- NCT06648915
- Testing
- Lipoprotein(a)
- Where
- South Korea
- Volunteers
- 364 people
- Sponsor
- Asan Medical Center
Symptomatic Severe Aortic Stenosis
FlexNav EU CE Mark Study
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic…
- Trial name
- NCT03724812
- Testing
- Portico Valve and FlexNav™ Delivery System
- Where
- 6 sites in Denmark, Italy and 2 more
- Volunteers
- 46 people
- Sponsor
- Abbott Medical Devices
Takayasu Arteritis
Drug-coated Balloon for Takayasu Arteritis Associated Renal Artery Stenosis
Takayasu arteritis associated renal artery stenosis (TARAS) is the biggest cause of hypertension in young people <40 years old. Hypertension caused by renal artery stenosis is usually hard to control in spite of two or more…
- Trial name
- NCT04137614
- Testing
- Drug coated balloon (DCB), Digital substraction angiography (DSA)
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shanghai Zhongshan Hospital
Aortic Stenosis, Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement (TAVR) Effects on Cardiac Conduction System
This is a prospective observational study, the purpose of which is to: 1. Characterize response of the AV conduction system to TAVR with various prostheses by recording continuous His bundle electrograms during valve placement.
- Conditions
- Aortic Stenosis, Transcatheter Aortic Valve Replacement, Heart Block
- Trial name
- TAVR-HBE (NCT04982406)
- Testing
- Transcatheter aortic valve replacement
- Where
- United States
- Volunteers
- 409 people
- Sponsor
- Beth Israel Deaconess Medical Center
Cardiomyopathy, Hypertrophic, Cardiomyopathy, Dilated
Individualized Early Risk Assessment for Heart Diseases
Heart failure (HF) is the common end-stage of different medical conditions. It is the only growing cardiovascular disease and its prognosis remains worse than that of many malignancies.
- Trial name
- IndivuHeart (NCT02417311)
- Testing
- Skin biopsy, genotyping and disease phenotyping
- Where
- Germany
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Aortic Valve Stenosis
Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
The management of symptomatic patients with moderate Aortic Stenosis (AS) remains challenging and tests that would give more definitive answers are needed.
- Trial name
- NCT02792452
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- London North West Healthcare NHS Trust
Aortic Stenosis, Aortic Insufficiency
Freedom SOLO Stentless Heart Valve Study
The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the Freedom SOLO heart valve.
- Trial name
- SOLO (NCT01115907)
- Testing
- Freedom SOLO Stentless Heart Valve
- Where
- 15 sites in United States, Canada
- Volunteers
- 251 people
- Sponsor
- Sorin Group USA, Inc.
Aortic Valve Stenosis, AV Block
Edwards SAPIEN 3 PPI Registry
There are patient related risk factors for PPI that can be identified and assessed in retrospective pooling of 1000+ TAVI patient datasets.
- Conditions
- Aortic Valve Stenosis, AV Block, Bundle-Branch Block
- Trial name
- Conduct (NCT03497611)
- Testing
- transcatheter valve implantation
- Where
- 4 sites in Germany
- Volunteers
- 1,000 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Aortic Valve Disease, Aortic Valve Stenosis
Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation
Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Heart Valve Diseases
- Trial name
- FAST TRACK (NCT05758909)
- Testing
- TF TAVI
- Where
- 13 sites in Spain
- Volunteers
- 585 people
- Sponsor
- Fundación EPIC
Aortic Stenosis
SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice
This is an international, mutli-center, prospective, consecutively enrolled, observational registry. 2000 patients are planned to be enrolled over one year at up to 150 participating sites.
- Trial name
- SOURCE 3 (NCT02698956)
- Testing
- TAVI (Transcatheter Aortic Valve Implantation)
- Where
- 73 sites in Denmark, Finland and 8 more
- Volunteers
- 2,000 people
- Sponsor
- Edwards Lifesciences
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