Clinical trials: Stenosis, Aortic
Aortic Stenosis, Transcatheter Aortic Valve Implantation
Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
The goal of the NEO2 BAV registry is to investigate the safety, effectiveness, and clinical performance of TAVI using the ACURATE neo2 valve in patients with severe BAV stenosis.
- Conditions
- Aortic Stenosis, Transcatheter Aortic Valve Implantation, Bicuspid Aortic Valve, Transcatheter Aortic Valve Replacement
- Trial name
- Neo2BAV (NCT06212050)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- 3 sites in Germany, Ireland and 1 more
- Volunteers
- 200 people
- Sponsor
- National University of Ireland, Galway, Ireland
Heart Valve Diseases, Aortic Valve Stenosis
BIOVALVE - I / II Clincial Investigation
First-in-Human clinical investigation to evaluate the safety and clinical performance of the BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis, which are as judged by the heart team…
- Trial name
- BIOVALVE (NCT02249000)
- Testing
- BIOVALVE prosthesis
- Where
- 13 sites in Belgium, Germany and 2 more
- Volunteers
- 68 people
- Sponsor
- Biotronik AG
Aortic Stenosis, Transthyretin Amyloidosis
Positron Emission Tomography / Magnetic Resonance Imaging in Aortic Stenosis
Aortic stenosis is the most common valve disease requiring surgery in the Western world. It is defined by progressive calcification and fibrosis of the valve leaflets and restricted valve opening.
- Trial name
- PASS (NCT03352089)
- Where
- United Kingdom
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- University of Edinburgh
Heart Valve Diseases, Multiple Valve Disease, Unspecified
European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study
This study aims to investigate the prevalence and characteristics of multiple and mixed valvular heart disease (MMVD), which includes combinations of stenotic or regurgitant lesions on cardiac valves.
- Conditions
- Heart Valve Diseases, Multiple Valve Disease, Unspecified, Aortic Valve Disease, Aortic Valve Stenosis
- Trial name
- EACVI-MMVD (NCT06235385)
- Testing
- Intervention not provided
- Where
- France
- Volunteers
- 1,500 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Aortic Valve Disease, Aortic Valve Stenosis
Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)
Transcatheter aortic valve implantation (TAVI) is a rapidly growing treatment option for patients with aortic valve stenosis. Stroke is a feared complication of TAVI, with an incidence of around 4-5% in the first 30 days.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Stroke, Bleeding
- Trial name
- NCT04437303
- Testing
- Continuation of oral anticoagulants, Interruption of oral anticoagulants
- Where
- 22 sites in Belgium, Denmark and 4 more
- Volunteers
- 858 people
- Sponsor
- St. Antonius Hospital
Atrial Fibrillation, Aortic Valve Stenosis
WATCH-TAVR, WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement
To evaluate the safety and effectiveness of the left atrial appendage occlusion with WATCHMAN Device in prevention of stroke and bleeding in patients with atrial fibrillation (AF) undergoing transcatheter aortic valve replacement…
- Trial name
- NCT03173534
- Testing
- WATCHMAN, TAVR
- Where
- 32 sites in United States
- Volunteers
- 350 people
- Sponsor
- samir kapadia
Aortic Stenosis
An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED)
The purpose of this study is to evaluate whether treatment with an investigational drug as compared to placebo will reduce the risk of major cardiovascular events in patients with aortic stenosis.
- Trial name
- NCT00092677
- Testing
- ezetimibe (+) simvastatin
- Volunteers
- 1,873 people
- Sponsor
- Organon and Co
Aortic Stenosis
Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis
To assess the safety and feasibility of Transcatheter Aortic Valve Replacement (TAVR) with commercially available bioprostheses in patients with severe, symptomatic aortic stenosis (AS) who are low-risk (STS score ≤3%) for…
- Trial name
- NCT02628899
- Testing
- Transfemoral TAVR, SAVR
- Where
- 11 sites in United States
- Volunteers
- 277 people
- Sponsor
- Medstar Health Research Institute
Heart Diseases, Aortic Stenosis, Severe
EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis
This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.
- Trial name
- EARLY TAVR (NCT03042104)
- Testing
- Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
- Where
- 77 sites in United States, Canada
- Volunteers
- 901 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis, Myocardial Fibrosis
Mechanism of Decompensation Evaluation - Aortic Stenosis
Aortic stenosis is the most common heart valve disease requiring intervention in high income countries. It is characterised by progressive valvular thickening, and restriction as well is hypertrophy and fibrosis of the left…
- Conditions
- Aortic Stenosis, Myocardial Fibrosis, Left Ventricular Hypertrophy
- Trial name
- MODE-AS (NCT03332745)
- Where
- United Kingdom
- Volunteers
- 90 people
- Sponsor
- University of Edinburgh
Aortic Stenosis, Aortic Stenosis, Severe
PARTNER 3 Trial - Aortic Valve-in-Valve
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
- Trial name
- NCT03003299
- Testing
- Edwards SAPIEN 3/SAPIEN 3 Ultra THV
- Where
- 51 sites in United States, Canada
- Volunteers
- 125 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
Effect of PCSK9 Inhibitors on Calcific Aortic Valve Stenosis
Calcific aortic stenosis (CAS) can cause severe adverse cardiac events, but there are currently no effective drugs that can prevent or delay the progression of the disease.
- Trial name
- NCT04968509
- Testing
- PCSK9 inhibitors and statins with or without ezetimibe, Statins with or without ezetimibe
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Beijing Anzhen Hospital
Atrial Fibrillation, Coronary Artery Disease
Prospective Project to Identify Biomarkers of Morbidity and Mortality in Cardiovascular Interventional Patients
The objective of CAREBANK study is to establish definitive relationships with human cardiac samples and clinical phenotypes in patients undergoing cardiac procedures.
- Conditions
- Atrial Fibrillation, Coronary Artery Disease, Aortic Valve Stenosis, Aortic Valve Disease
- Trial name
- CAREBANK (NCT03444259)
- Testing
- Cardiac surgery
- Where
- Finland
- Volunteers
- 1,001 people
- Sponsor
- University of Turku
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
Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation
The ACCESS-TAVI trial is an investigator-initiated, prospective, randomized, multicenter, open-label clinical trial. The objective of the trial is to compare two different vascular closure device strategies for large bore…
- Trial name
- ACCESS-TAVI (NCT05503199)
- Testing
- Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo)., Combination of two ProGlides or ProStyles (Abbott Vascular).
- Where
- Germany
- Volunteers
- 450 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Aortic Valve Stenosis and Insufficiency
Long-term Prognosis and Valve Durability of TAVR
This registry aims to evaluate the long-term prognosis and valve durability of transcatheter aortic valve replacement (TAVR) in a real-world setting.
- Trial name
- NCT06379386
- Testing
- Transcatheter aortic valve replacement
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Xijing Hospital
Aortic Stenosis, Mitral Regurgitation
Evaluating Infrasonic Hemodynography
This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system.
- Conditions
- Aortic Stenosis, Mitral Regurgitation, Pulmonary Hypertension, Heart Failure, Systolic
- Trial name
- NCT04636892
- Testing
- MindMics earbud
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Scripps Health
Aortic Stenosis
PERIGON Japan Trial
The purpose of this study is to evaluate the safety and effectiveness of the 17mm MDT-2215 aortic valve bioprosthesis.
- Trial name
- NCT02686814
- Testing
- 17mm MDT-2215 aortic valve bioprosthesis
- Where
- 10 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Medtronic Cardiac Surgery
Aortic Stenosis
PROVE ACURATE neo2™ - Post Market Safety and Performance Surveillance in Aortic Stenosis
Aortic valve sclerosis (aortic valve thickening and calcification without pressure gradient) is one of the most common valvular abnormalities in the Western world.
- Trial name
- PROVE (NCT05539573)
- Testing
- Planned TAVI with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system.
- Where
- 27 sites in France, Germany and 2 more
- Volunteers
- 1,043 people
- Sponsor
- University of Leipzig
Aortic Valve Stenosis, Cardiovascular Diseases
Comparison of TAVR With SAVR in Younger Low Surgical Risk Patients With Severe Aortic Stenosis
A randomized clinical trial investigating transcatheter (TAVR) versus surgical (SAVR) aortic valve replacement in patients 75 years of age or younger suffering from severe aortic valve stenosis.
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases
- Trial name
- NOTION-2 (NCT02825134)
- Testing
- Transcatheter aortic valve replacement, Surgical aortic valve replacement
- Where
- 9 sites in Denmark, Finland and 3 more
- Volunteers
- 376 people
- Sponsor
- Ole De Backer