Clinical trials: Aortic Stenosis
Cardiomyopathy, Hypertrophic
A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).
- Trial name
- ODYSSEY-HCM (NCT05582395)
- Testing
- Mavacamten
- Where
- 224 sites in United States, Australia and 21 more
- Volunteers
- 580 people
- Sponsor
- Bristol-Myers Squibb
Aortic Stenosis, Nursing Caries
The Effect of Education and Follow-up Program in Patients Undergoing TAVI
Aortic stenosis is a progressive disease that affects approximately 3% of adults aged 75 and over. If left untreated, the mortality rate of aortic stenosis, which becomes symptomatic in a short time, is 50% in the first year…
- Trial name
- NCT05625269
- Testing
- Education
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Dokuz Eylul University
Aortic Valve Stenosis
Validation of a Novel, Non-Dimensional Approach for Estimation of Pressure Gradients in Aortic Stenosis
A novel, image-based model for estimation of the pressure gradient across stenosed aortic valves is compared against invasively measured pressure gradients from clinical routine.
- Trial name
- AVD-PowerLaw (NCT04600739)
- Testing
- TAVI
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- German Heart Institute
Aortic Valve Stenosis
Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis
The primary objective of the present trial is to demonstrate the safety and effectiveness of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small aortic annuli and deemed difficult for…
- Trial name
- NCT01634269
- Testing
- MDT-2111 TAVI 23 mm
- Where
- 4 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Medtronic Cardiovascular
Hypertrophic Cardiomyopathy (HCM), Cardiac Myosin Inhibitors
Radiomics Analysis of CMR Imaging for Arrhythmic Risk Prediction in Hypertrophic Cardiomyopathy, With Longitudinal Risk Reassessment After Mavacamten Therapy in Obstructive Patients
Hypertrophic cardiomyopathy (HCM) is one of the leading causes of sudden cardiac death (SCD), particularly in young and middle-aged individuals.
- Trial name
- RADIOMICS-OHCM (NCT07695272)
- Where
- Italy
- Volunteers
- 2,000 people
- Sponsor
- Centro Cardiologico Monzino
Hypertrophic Cardiomyopathy
The Efficacy and Mechanism of Trientine in Patients With Hypertrophic Cardiomyopathy
This research study has been designed to test whether a drug called trientine dihydrochloride (also called Cufence) reduces heart muscle thickening, improves exercise capacity, improves heart function and reduces abnormal heart…
- Trial name
- TEMPEST (NCT04706429)
- Testing
- Trientine
- Where
- 7 sites in United Kingdom
- Volunteers
- 154 people
- Sponsor
- Manchester University NHS Foundation Trust
Hypertrophic Cardiomyopathy (HCM)
Identification of Risk Factors for Arrhythmia in Children and Adolescents With Hypertrophic Cardiomyopathy
This study will review medical information collected on children and adolescents with hypertrophic cardiomyopathy (HCM) to try to identify risk factors for arrhythmias (abnormal heart rhythms) in these patients and better guide…
- Trial name
- NCT00753233
- Where
- United States
- Volunteers
- 145 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Aortic Stenosis
Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation.
Transcatheter Aortic Valve Implantation (TAVI) using femoral access is an option for definitive treatment of aortic stenosis when open-heart surgery is considered inappropriate.
- Trial name
- NCT01237743
- Testing
- Transcatheter aortic valve implantation.
- Where
- Sweden
- Volunteers
- 21 people
- Sponsor
- Sahlgrenska University Hospital
Aortic Valve Stenosis
Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS
The aim of this study is to test the diagnostic added value of Volume Challenge (VC) to low-dose dobutamine stress echocardiography (LDDSE) in patients with a low-flow, low-gradient aortic stenosis (LFLGAS).
- Trial name
- FLOW-AS (NCT03617406)
- Testing
- Volume Challenge
- Where
- Switzerland
- Volunteers
- 50 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Severe Aortic Valve Stenosis
In-vitro Benchmarking of Currently Available Heart Valve Prostheses for Surgical and Percutaneous Treatment of Aortic Stenosis With Small Annulus, Followed by In-vivo Validation
The general objective of this study is to compare in vitro and in vivo the hemodynamic performance of different types of aortic valve prostheses and possible surgical implantation techniques.
- Trial name
- SurPASS (NCT06859255)
- Testing
- MRI
- Where
- 2 sites in Italy
- Volunteers
- 200 people
- Sponsor
- IRCCS Policlinico S. Donato
Aortic Stenosis, Diastolic Dysfunction
AI in Outpatient Practice for Diagnosing Aortic Stenosis and Diastolic Dysfunction
Two recently developed artificial intelligence-enabled electrocardiogram (AI-ECG) models have been developed to detect aortic stenosis (AS) and diastolic dysfunction (DD).
- Trial name
- NCT06580158
- Testing
- AI-ECG Dashboard, Point of care ultrasound (POCUS)
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Mayo Clinic
Aortic Valve Stenosis
Randomized Study to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in Patients With Aortic Stenosis.
Atherosclerosis and aortic stenosis share inflammatory etiopathogenic characteristics in common. We hypothesized that statins therapy would decrease inflammatory markers concentrations in patients with degenerative aortic…
- Trial name
- NCT00404287
- Testing
- Fluvastatin
- Where
- Spain
- Volunteers
- 164 people
- Sponsor
- AORTICA Group
Aortic Valve Stenosis
Evaluation of an Intervention to Reduce the Time to Treatment for TAVI Patients
Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population.
- Trial name
- TREAT (NCT05237804)
- Testing
- Patient component, Organisational component
- Where
- 2 sites in France
- Volunteers
- 828 people
- Sponsor
- University Hospital, Rouen
Severe and Symptomatic Aortic Stenosis, Stable Coronary Disease
Post TAVI Coronary REVASCularisation Guided by Myocardial Perfusion Imaging: a Prospective Open Label Pilot Study: The REVASC-TAVI Study
Evaluation of a strategy of selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging.
- Trial name
- REVASC-TAVI (NCT02797158)
- Testing
- TAVI procedure
- Where
- France
- Volunteers
- 71 people
- Sponsor
- University Hospital, Montpellier
Aortic Stenosis, Aortic Valve Stenosis
Standardized Invasive Hemodynamics for Elevated Gradients Post TAVR (DISCORDANCE TAVR)
The DISCORDANCE TAVR study will determine the discordance between echocardiography-derived and invasive transaortic gradients, as determined by a consistent and reproducible technique (Standardized Invasive Hemodynamics)…
- Trial name
- NCT04827238
- Testing
- Standardized Invasive Hemodynamics
- Where
- 9 sites in United States, Canada
- Volunteers
- 49 people
- Sponsor
- University of British Columbia
Aortic Stenosis, PCSK9 Inhibitor
A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy of PCSK-9 Inhibitors in Delaying the Progression of Calcified Aortic Valve Disease
The aim of this clinical trial is to understand whether the drug PCSK9 inhibitor can slow the progression of calcific aortic valve disease and to understand the safety of the drug.
- Conditions
- Aortic Stenosis, PCSK9 Inhibitor, Calcified Aortic Valve Disease
- Trial name
- NCT06996223
- Testing
- The Group A received PCSK9 inhibitor plus statin therapy
- Volunteers
- 316 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Severe Aortic Stenosis, Transcatheter Aortic Valve Replacement
Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH
The objective of this study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR).
- Conditions
- Severe Aortic Stenosis, Transcatheter Aortic Valve Replacement, Aortic Valve Replacement
- Trial name
- BRAVO 2/3 (NCT01651780)
- Testing
- Bivalirudin, Unfractionated Heparin
- Where
- 33 sites in Canada, France and 5 more
- Volunteers
- 803 people
- Sponsor
- The Medicines Company
Severe Aortic Stenosis, Aortic Valve Stenosis
HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON
The purpose of this study is to evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at High Risk for aortic valve replacement surgery.
- Trial name
- HORIZON (NCT02157142)
- Testing
- HLT Transcatheter Aortic Valve System
- Where
- Germany
- Volunteers
- 4 people
- Sponsor
- HLT Inc.
Aortic Valve Stenosis
PREVAIL-J - Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan)
A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, Ascendra2™ transapical delivery…
- Trial name
- NCT01113983
- Testing
- Transcatheter aortic valve implantation
- Where
- 3 sites in Japan
- Volunteers
- 64 people
- Sponsor
- Edwards Lifesciences
Calcific Aortic Stenosis
Effective Management of Calcific Aortic Stenosis in the Elderly
Although aortic valve replacement is recommended for any symptomatic severe calcific aortic stenosis, the therapeutic decision may be difficult. because of patient age and comorbidities.
- Trial name
- RAC (NCT03343314)
- Volunteers
- 1,101 people
- Sponsor
- French Cardiology Society
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