Clinical trials: Aortic Valve Stenosis
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
Heart Failure, Aortic Stenosis, Severe
Effects of Levosimendan on Cardiac Function After TAVR in Patients With Heart Failure
Patients with severe aortic stenosis combined with severe heart failure often miss the opportunity for surgery, and the prognosis is poor with drug therapy alone.In recent years, the emergence of transcatheter aortic valve…
- Trial name
- NCT06196177
- Testing
- Levosimontane injection
- Where
- China
- Volunteers
- 112 people
- Sponsor
- Qilu Hospital of Shandong University
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Aortic Stenosis With COmplex PCI (ASCOP) Features Retrospective Registry on Contemporary Management and Outcomes
To describe the prevalence and clinical features of patients with severe aortic stenosis undergoing TAVI and concomitant clinically indicated, complex and/or high-risk PCI
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement, Angioplasty, Balloon, Coronary, Coronary Artery Disease
- Trial name
- ASCOP (NCT05750927)
- Testing
- Transcatheter aortic valve intervention (TAVI) and percutaneous coronary intervention (PCI)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Niguarda Hospital
Aortic Valve Disease, Aortic Valve Stenosis
PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban
Currently, warfarin is the only approved anticoagulation for patients with mechanical valves. The purpose of this study is to determine if participants with an On-X Prosthetic Heart Valve / On-X aortic valve can be maintained…
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Failure
- Trial name
- NCT04142658
- Testing
- Apixaban 5 MG, Apixaban 2.5 MG, Warfarin
- Where
- 62 sites in United States
- Volunteers
- 863 people
- Sponsor
- Artivion Inc.
Congenital Aortic Stenosis
Cardiac Imaging in Adults With Congenital Aortic Stenosis
The CAS study is a prospective observational cohort study investigating the effects of congenital aortic stenosis (ConAoS) on the left ventricular function and the prevalence, pattern and expanse of left ventricular hypertrophy…
- Trial name
- CAS (NCT05252351)
- Where
- Netherlands
- Volunteers
- 75 people
- Sponsor
- Erasmus Medical Center
Symptomatic Severe Aortic Stenosis
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic…
- Trial name
- PII A (NCT01314313)
- Testing
- TAVR Implantation with SAPIEN XT, SAVR Implantation
- Where
- 57 sites in United States, Canada
- Volunteers
- 2,032 people
- Sponsor
- Edwards Lifesciences
Heart Valve Diseases
Clinical Investigation of the Freedom SOLO Stentless Heart Valve
This is a trial to demonstrate the safety and effectiveness of the Freedom SOLO heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
- Trial name
- NCT00876525
- Testing
- Surgical Replacement of the diseased native aortic heart valve with the Freedom SOLO Valve prosthesis
- Where
- 19 sites in Austria, Belgium and 6 more
- Volunteers
- 702 people
- Sponsor
- Corcym S.r.l
Aortic Valve Replacement
Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark
The primary objective of this clinical investigation is to assess the safety and effectiveness of the Perceval S valve at 12 months after implantation when used to replace a diseased or dysfunctional aortic valve or aortic valve…
- Trial name
- CAVALIER (NCT01368666)
- Testing
- Perceval S Valve Prosthesis
- Where
- 26 sites in Austria, Belgium and 6 more
- Volunteers
- 658 people
- Sponsor
- Corcym S.r.l
Aortic Valve Disease, Aortic Stenosis
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively.
- Trial name
- PERSIST-AVR (NCT02673697)
- Testing
- Perceval valve, other stented biological valve
- Where
- 47 sites in United States, Austria and 10 more
- Volunteers
- 914 people
- Sponsor
- Corcym S.r.l
Aortic Valve Disease, Aortic Stenosis
Sorin Universal REgistry on Aortic Valve Replacement
Multi-center, International, Prospective, Non comparative, Non randomized, Open label. 5,000 patients to be enrolled approximately worldwide.
- Trial name
- SURE-AVR (NCT02679404)
- Where
- 52 sites in United States, Australia and 15 more
- Volunteers
- 2,758 people
- Sponsor
- Corcym S.r.l