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
Aortic Valve Stenosis
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.
- Trial name
- NCT04639258
- Testing
- Medtronic Evolut™ PRO+ System
- Where
- 8 sites in United States, Australia and 3 more
- Volunteers
- 11 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Stenosis
Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation
A single-center, investigator-initiated, single arm interventional study in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) in the Erasmus Medical Center in Rotterdam (NL).
- Trial name
- REDOX-TAVI (NCT04171726)
- Testing
- Edoxaban
- Where
- Netherlands
- Volunteers
- 100 people
- Sponsor
- Erasmus Medical Center
Aortic Stenosis, Heart Failure
High-Sensitivity Troponin T Plasma Levels in Patients With Aortic Stenosis (Tyrolean Aortic Stenosis Study-2)
TASS-2 (Tyrolean Aortic Stenosis Study-2) aims to characterize the clinical value of minimally elevated troponin T plasma levels both in patients with asymptomatic and symtomatic aortic stenosis.
- Conditions
- Aortic Stenosis, Heart Failure, Syncope, Angina Pectoris
- Trial name
- TASS-2 (NCT02448485)
- Testing
- Aortic Valve Intervention (surgical or transcatheter)
- Where
- Austria
- Volunteers
- 10,000 people
- Sponsor
- Medical University Innsbruck
Hypertrophic Cardiomyopathy
Family Studies of Inherited Heart Disease
Hypertrophic cardiomyopathy (HCM) is a genetically inherited heart disease. It causes thickening of heart muscle, especially the chamber responsible for pumping blood out of the heart, the left ventricle.
- Trial name
- NCT00001225
- Where
- United States
- Volunteers
- 5,880 people, healthy volunteers welcome
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
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 Stenosis
Self-Centering Guide Catheter Feasibility Study
An evaluation of the feasibility of using the Self-Centering Guide Catheter to deliver a guide wire across a stenotic native aortic valve into the left ventricle.
- Trial name
- NCT02639494
- Testing
- Self-Centering Guide Catheter
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Disease, Transcatheter Aortic Valve Replacement
The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures
TAVR patients exhibiting post-procedural residual AR had higher mortality and hospitalization rates due to heart failure, with the extent of this association increasing proportionally to the severity of the regurgitation.
- Conditions
- Aortic Valve Disease, Transcatheter Aortic Valve Replacement, Aortic Valve Stenosis, Hemodynamic Measurement
- Trial name
- SAVVY (NCT05082337)
- Testing
- SAVVY guidewire
- Where
- 2 sites in Canada
- Volunteers
- 20 people
- Sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Atrial Fibrillation, Hypertrophic Cardiomyopathy
HCM-AF Ablation With ACUTUS
BACKGROUND About 1/4 of patients with hypertrophic cardiomyopathy (HCM) seem to develop atrial fibrillation (AF) over their life-span.
- Trial name
- NCT04090437
- Testing
- Catheter ablation procedure
- Volunteers
- 20 people
- Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
Aortic Stenosis
Utility of Exercise-induced N-terminal (NT) Pro-brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis
One hundred patients with moderate to severe asymptomatic aortic stenosis (AS) will be asked to exercise on a treadmill. NT-pro-BNP levels will be drawn before and after exercise.
- Trial name
- AS-BNP (NCT00567437)
- Testing
- NT-pro-BNP levels
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Duke University
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System FOUNDATION Study
The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population.
- Conditions
- Aortic Valve Disease, Aortic Stenosis, Rapid Deployment Valves
- Trial name
- FOUNDATION (NCT02338154)
- Where
- 27 sites in Austria, Denmark and 7 more
- Volunteers
- 516 people
- Sponsor
- Edwards Lifesciences
Type II Diabetes
Type II Diabetes Influence on Left Ventricular Remodeling and Outcomes in Patients Undergoing Aortic Valve Replacement Surgery.
This project focuses on the physiopathology of left ventricular remodeling associated with type II diabetes in patients with aortic valve stenosis referred for surgical aortic valve replacement.
- Trial name
- DIAPASON (NCT01862237)
- Testing
- Intervention
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Hospices Civils de Lyon
Aortic Valve Stenosis
Early neo2 Registry of the Acurate neo2 TAVI Prosthesis
The Early neo2 registry will study up to 500 patients treated with the updated Boston Acurate neo2 TAVI prosthesis at various European hospitals.
- Trial name
- NCT04810195
- Testing
- Boston Scientific Acurate neo2 TAVR device
- Where
- 4 sites in Denmark, Germany and 1 more
- Volunteers
- 554 people
- Sponsor
- Andreas Rück
Sudden Cardiac Arrest, Sudden Arrhythmic Death Syndrome
Hearts in Rhythm Organization (HiRO)National Registry and Bio Bank
The Hearts in Rhythm Organization (HiRO) is a national network of Canadian researchers/clinicians, working towards a better understanding of the rare genetic causes of sudden cardiac death (SCD).
- Conditions
- Sudden Cardiac Arrest, Sudden Arrhythmic Death Syndrome, Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC), Long QT Syndrome (LQTS)
- Trial name
- HiRO (NCT04189822)
- Where
- Canada
- Volunteers
- 10,000 people
- Sponsor
- University of British Columbia
Emphysema, Pulmonary Disease, Chronic Obstructive
Evaluating Genetic Factors That May Contribute to Elastin Function and the Development of Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease (COPD) is a lung disease that is primarily caused by cigarette smoking. The breakdown of elastin, a protein found in the lungs, can cause lung damage and may contribute to the development of…
- Trial name
- NCT00725309
- Where
- United States
- Volunteers
- 255 people
- Sponsor
- Washington University School of Medicine
Myocardial Infarction (MI), Hypertrophic Cardiomyopathy (HCM)
The Application of T1 Mapping in Real-World
The goal of this observational study is to create a comprehensive real-world spectrum of T1 mapping measurements across different heart conditions.
- Conditions
- Myocardial Infarction (MI), Hypertrophic Cardiomyopathy (HCM), Dilated Cardiomyopathy (DCM), Arrhythmogenic Cardiomyopathy
- Trial name
- NCT07354646
- Testing
- Magnetic Resonance Imaging with Contrast
- Where
- China
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Symptomatic Severe Aortic Stenosis
Portico Next Generation Approval Study
The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the…
- Trial name
- NCT04011722
- Testing
- Portico™ NG (Navitor) Valve and FlexNav™ Delivery System, Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
- Where
- 28 sites in United States, Australia and 3 more
- Volunteers
- 333 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis, Transthyretin Amyloidosis
Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis
The purpose of this study is to determine the prevalence of transthyretin cardiac amyloidosis (TTR-CA) among patients with moderate and severe aortic stenosis in Southeast Minnesota using 99mTc-PYP single-photon positive emission…
- Conditions
- Aortic Stenosis, Transthyretin Amyloidosis, Transthyretin Amyloid Cardiomyopathy, Transthyretin Cardiac Amyloidosis
- Trial name
- NCT04899180
- Testing
- 99mTc-PYP
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Mayo Clinic
Aortic Valve Stenosis
The preDIlatation in tRanscathEter aortiC Valve implanTation Trial
This is a randomized trial that will evaluate the role of balloon aortic valvuloplasty (BAV) on the outcome of patients undergoing transcatheter aortic valve implantation (TAVI) procedure.
- Trial name
- DIRECT (NCT02448927)
- Testing
- balloon aortic valvuloplasty, Transcatheter Aortic Valve Implantation
- Where
- 4 sites in Greece, Israel
- Volunteers
- 170 people
- Sponsor
- National and Kapodistrian University of Athens
Hypertrophic Obstructive Cardiomyopathy \(HOCM\)
Myocardial Perfusion Changes Following Optimal Medical Treatment in Symptomatic Hypertrophic Cardiomyopathy
Background: Microvascular dysfunction is a hallmark of hypertrophic obstructive cardiomyopathy (HOCM) and can be visualized non-invasively using cardiac magnetic resonance (CMR) perfusion imaging.
- Trial name
- oHCM (NCT07150299)
- Testing
- Mavacamten in clinical routine use
- Where
- Austria
- Volunteers
- 20 people
- Sponsor
- Medical University of Vienna
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