Clinical trials: Valve Disease, Aortic
Aortic Stenosis
Prediction of Long-term Outcome in Aortic Stenosis After Valve Intervention
Patients with severe aortic stenosis accepted for transcatheter intervention or open surgery are included before the intervention, and then followed up with clinical visits during the first year after intervention.
- Trial name
- NCT05629104
- Testing
- There is no intervention since it is an observational study patients are treated according to clinical praxis
- Where
- Sweden
- Volunteers
- 300 people
- Sponsor
- Uppsala University
Hypertrophic Cardiomyopathy (HCM)
Aficamten and Patient-Reported Outcomes in Real-World nHCM
This multicenter, prospective, observational, real-world clinical study aims to evaluate the efficacy and safety of Aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) by prospectively…
- Trial name
- CAMPHOR-HCM (NCT07846176)
- Testing
- receiving aficamten
- Volunteers
- 100 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Low-gradient Aortic Stenosis, Aortic Stenosis
AI Assessment of Low-Gradient Aortic Stenosis Severity Based on Echocardiography
The purpose of this study is to evaluate the effectiveness of an artificial intelligence (AI) model developed by the investigators for identifying severe low-gradient aortic valve stenosis.
- Trial name
- ASAI-POL (NCT07144189)
- Testing
- AI diagnostic test for severe low-gradient aortic stenosis
- Where
- Poland
- Volunteers
- 300 people
- Sponsor
- National Institute of Cardiology, Warsaw, Poland
Hypertrophic Cardiomyopathy
Functional Capacity and Quality of Life Following Septal Myectomy in Patients With HCM
Investigators aim to assess changes in exercise capacity and quality of life after septal myectomy in patient with hypertrophic cardiomyopathy.
- Trial name
- SPIRIT-HCM (NCT03092843)
- Where
- United States
- Volunteers
- 177 people
- Sponsor
- The Cleveland Clinic
Aortic Valve Stenosis
Hydra Single-centre Experience - Copenhagen, Denmark
The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure.
- Trial name
- NCT06342635
- Testing
- Hydra Transcatheter Aortic Valve (THV) Series
- Where
- Denmark
- Volunteers
- 50 people
- Sponsor
- Sahajanand Medical Technologies Limited
Aortic Valve Stenosis
The Effect of Lipitor on Aortic Stenosis
The purpose of this study is to find out if an approved medicine that is used to lower cholesterol called Lipitor can slow or stop progressive narrowing of the aortic heart valve in patients with a condition called aortic…
- Trial name
- NCT00590135
- Testing
- atorvastatin (Lipitor)
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- The Cleveland Clinic
Aortic Stenosis
Identifying Biological Markers of Cardiovascular Events in Patients With Aortic Stenosis or TAVI
Aortic stenosis, a common cardiovascular disease, is pathophysiologically associated with a chronic inflammatory myocardial reaction and fibrosis leading to cardiac dysfunction and impaired coronary perfusion.
- Trial name
- Bio-TAVI (NCT06713889)
- Testing
- Biocollection, Quality of life questionnaires
- Where
- 2 sites in France
- Volunteers
- 125 people
- Sponsor
- Hospices Civils de Lyon
HCM - Hypertrophic Cardiomyopathy, Mavacamten
Efficacy of Mavacamten in Patients With Symptomatic Latent Obstructive Hypertrophic Cardiomyopathy
This study aimed to evaluate the efficacy and safety of Mavacamten compared to no treatment in patients with symptomatic latent obstructive hypertrophic cardiomyopathy.
- Trial name
- NCT06947590
- Testing
- mavacamten
- Where
- China
- Volunteers
- 78 people
- Sponsor
- Xu Liu
Aortic Valve Stenosis
The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration (POPular PET TAVI)
A multicentre cross-sectional cohort study to assess the difference in bioprosthetic micro-calcification activity, detected with 18F-NaF PET-CT, as early marker of transcatheter valve degeneration, between patients with vs.
- Trial name
- NCT05758662
- Testing
- 18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE)
- Where
- 4 sites in Denmark, Netherlands and 1 more
- Volunteers
- 180 people
- Sponsor
- St. Antonius Hospital
Aortic Valve Disease, Aortic Valve Stenosis
VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）
This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.
- Trial name
- VITAL (NCT05977257)
- Testing
- VitaFlow® Transcatheter Aortic Valve Replacement System
- Where
- 4 sites in China
- Volunteers
- 89 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Cardiomyopathy, Hypertrophic
Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy
DDD pacing improves symptoms and relieves LV outflow tract (LVOT) obstruction in most patients with hypertrophic cardiomyopathy (HCM).
- Trial name
- NCT00001530
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
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 Stenosis
Expression of Sodium-glucose Co-transporter 2 in Human Heart
The aim of the study is to evaluate the expression of Sodium Glucose Co-transporter 2 (SGLT2) in myocardium from patients with aortic stenosis.
- Trial name
- SGLT2-MICRA (NCT05830760)
- Testing
- Myocardium biopsy
- Where
- France
- Sponsor
- University Hospital, Strasbourg, France
Valvular Heart Disease, Valvular Stenosis
National Tunisian Registry of Valvulopathies (NATURE-VALVE)
The National Tunisian Registry of Valvulopathies is an observational, prospective and multicenter study aiming to assess the epidemiological, clinical and therapeutic profile of valve disease in tunisian departments of…
- Conditions
- Valvular Heart Disease, Valvular Stenosis, Valvular Insufficiency
- Trial name
- NATURE-VALVE (NCT04509479)
- Testing
- Valve replacement
- Where
- Tunisia
- Volunteers
- 3,637 people
- Sponsor
- Dacima Consulting
Coronary Artery Disease, Aortic Valve Disease
Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery
Open heart surgery, including coronary artery bypass grafting (CABG) and/or aortic valve replacement (AVR) is associated with a significant risk of mortality.
- Trial name
- GLORIOUS-II (NCT05635227)
- Testing
- Dexamethasone phosphate, Isotonic sodium chloride (0.9%), Olanzapine 10 MG
- Where
- Denmark
- Volunteers
- 1,200 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Heart Valve Diseases, Aortic Diseases
Effective Myocardial Protection Time of Del Nido Cardioplegia in Adult Cardiac Surgery
This single-center, prospective, observational cohort study quantifies the effective myocardial protection window of Del Nido cardioplegia during adult open-heart surgery performed under cardiopulmonary bypass (CPB) and aortic…
- Conditions
- Heart Valve Diseases, Aortic Diseases, Myocardial Ischemia, Reperfusion Injury, Myocardial
- Trial name
- DN-TIME-2025 (NCT07249424)
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Muhammet Talha Ceran, MD
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Trifecta™ Long Term Follow-Up (LTFU) Study
The Trifecta™ LTFU Study is a single-arm, multi-center, prospective, non-randomized, post-market study conducted in the United States and Canada to collect long-term safety and effectiveness data through 10 years after implant of…
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT01593917
- Testing
- Trifecta™ Valve
- Where
- 11 sites in United States, Canada
- Volunteers
- 329 people
- Sponsor
- Abbott Medical Devices
Symptomatic Aortic Stenosis, Aortic Valve Stenosis
SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic…
- Conditions
- Symptomatic Aortic Stenosis, Aortic Valve Stenosis, Aortic Valve Replacement
- Trial name
- SMART (NCT04722250)
- Testing
- Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems, Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
- Where
- 92 sites in United States, Canada and 11 more
- Volunteers
- 1,103 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Insufficiency
Open Label RCT for Chronic Severe AR : Entresto vs. CCB/ARB
The purpose of this study is to assess the efficacy of sacubitril-valsartan compared to the combination of ARB/CCB on left ventricular remodeling in patients with chronic aortic valve regurgitation.
- Trial name
- REVERSE-AR (NCT05212597)
- Testing
- Sacubitril-valsartan, Amlodipine-losartan
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Samsung Medical Center
Heart Failure With Normal Ejection Fraction, Left Ventricular Hypertrophy
Imaging Histone Deacetylase in the Heart
The overall goal of this PET-MR imaging trial is to evaluate 11C-Martinostat, a histone deacetylase targeted radioligand, in patients with aortic stenosis, individuals with diabetes, and healthy volunteers.
- Conditions
- Heart Failure With Normal Ejection Fraction, Left Ventricular Hypertrophy, Aortic Valve Stenosis, Diabetes
- Trial name
- NCT03549559
- Testing
- 11C-Martinostat, PET-MRI
- Where
- United States
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
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