Clinical trials: Stenoses, Aortic
Hypertrophic Cardiomyopathy
A Trial of HS-10511 in Healthy Subjects
This study is a phase I, randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, and pharmacodynamic (PK) and pharmacodynamic (PD) characteristics of HS-10511 when administered as single…
- Trial name
- NCT06210607
- Testing
- HS-10511 Tablets
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Aortic Stenosis, Arteriosclerosis
Aortic Stenosis in Subjects With Heterozygous Familial Hypercholesterolemia on Prolonged Treatment With Statins
Aortic stenosis (AE) is a disease that has been increasing steadily in recent years in most countries, including Spain.Risk factors for the development of AE include age, hypercholesterolemia, diabetes mellitus and arterial…
- Conditions
- Aortic Stenosis, Arteriosclerosis, Familial Hypercholesterolemia, Conventional Transthoracic Echocardiogram
- Trial name
- NCT03310671
- Testing
- Echocardiogram
- Where
- Spain
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Instituto Aragones de Ciencias de la Salud
Aortic Stenosis
Treatment of Aortic Stenosis in Brazil: Cost-Utility Analysis of TAVI vs SAVR
TEAM-Br is a randomized, prospective, cost-utility study comparing transcatheter aortic valve implantation (TAVI) versus surgical aortic vale replacement in Brazil.
- Trial name
- TEAm-BR (NCT04067089)
- Testing
- TAVR - Transcatheter aortic valve replacement, Surgical aortic valve replacement
- Where
- Brazil
- Volunteers
- 126 people
- Sponsor
- Hospital do Coracao
Hypertrophic Obstructive Cardiomyopathy (HOCM)
Septal Ablation for Obstructive HCM
Hypertrophic cardiomyopathy (HCM) is a common clinical genetic-related disease, with a global incidence of 0.2%-0.5%, but only a few cases (10-20%) have been clinically diagnosed.
- Trial name
- NCT06277960
- Testing
- percutaneous intramyocardial septal radiofrequency ablation system
- Where
- China
- Volunteers
- 20 people
- Sponsor
- SuZhou Sinus Medical Technologies Co.,Ltd
Renal Infarction
Trans-aortic Valve Replacement and Renal Infarction
Kidney Magnetic Resonance assessment before and after undergoing transcatheter aortic valve replacement
- Trial name
- NCT03474250
- Testing
- Magnetic Resonance test for kidney
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- Sheba Medical Center
Aortic Stenosis
Microembolic Signals and Cerebrospinal Fluid Markers of Neuronal Damage After Surgical Aortic Valve Replacement
The use of MRI have shown that the incidence of postoperative cerebral lesions due to cerebral embolization is high (1). Nonetheless the extent of postoperative neurological dysfunction is only a fraction of the actual amount of…
- Trial name
- NCT01319799
- Testing
- Open heart surgery
- Where
- Sweden
- Volunteers
- 10 people
- Sponsor
- Sahlgrenska University Hospital
Cardiomyopathy, Hypertrophic Obstructive
BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy
The main purpose of this trial is to find out whether BHB-1893 works better than metoprolol in adults with symptoms of obstructive hypertrophic cardiomyopathy (oHCM).
- Trial name
- LIONHEART-HCM (NCT07755904)
- Testing
- BHB-1893, Metoprolol
- Where
- 3 sites in United States
- Volunteers
- 210 people
- Sponsor
- Braveheart Bio, Inc.
Severe Aortic Valve Stenosis
A Prospective, Multicenter, Observational Study of the Safety and Efficacy of Emergency Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis
The research name of this project is: A prospective, multicenter and observational study on the safety and effectiveness of emergency transcatheter aortic valve replacement (TAVR) in the treatment of patients with severe aortic…
- Trial name
- E-TAVR-2025 (NCT07108478)
- Testing
- Transcatheter aortic valve and recyclable delivery system
- Where
- China
- Volunteers
- 35 people
- Sponsor
- Qilu Hospital of Shandong University
Aortic Valve Stenosis, Coronary Artery Disease
Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients Undergoing TAVR
The objective of this study is to evaluate the relationship between fractional flow reserve (FFR) derived from coronary computed tomography angiography (FFRct) before transcatheter aortic valve replacement (TAVR) and FFR after…
- Trial name
- FORTUNA (NCT03665389)
- Testing
- iFR / FFR measurement
- Volunteers
- 25 people
- Sponsor
- Kobe University
Aortic Stenosis
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
- Trial name
- P3 (NCT02675114)
- Testing
- SAVR, SAPIEN 3 THV
- Where
- 77 sites in United States, Australia and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial
The purpose of the study is to evaluate the safety and clinical performance of the Engager Transcatheter Aortic Valve Implantation System in patients with severe aortic valve stenosis who are at high risk for surgical valve…
- Trial name
- NCT01348438
- Testing
- Medtronic Engager Transcatheter Aortic Valve Implantation System
- Where
- 9 sites in Belgium, Germany and 2 more
- Volunteers
- 125 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Valve Disease, Aortic Valve Stenosis
Early Feasibility Study for the Foldax Tria Aortic Heart Valve
The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Aortic Valve to collect evidence on the device's safety and performance.
- Trial name
- NCT03851068
- Testing
- Foldax Tria Aortic Valve
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Foldax, Inc
Aortic Valve Calcification, Aortic Valve Stenosis
VALVOSOFT® Pivotal Study
The objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis
- Trial name
- NCT05235568
- Testing
- VALVOSFT intervention
- Where
- 11 sites in France, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- Cardiawave SA
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
Aortic Stenosis
ACURATE Prime XL Human Feasibility Study
To evaluate feasibility and safety of the ACURATE Prime™ XL Transfemoral Aortic Valve System for transcatheter aortic valve implantation (TAVI) in subjects with severe native aortic stenosis who are indicated for TAVI.
- Trial name
- NCT05224245
- Testing
- ACURATE Prime XL Transfemoral Aortic Valve System
- Where
- 3 sites in Australia
- Volunteers
- 13 people
- Sponsor
- Boston Scientific Corporation
Aortic Stenosis, Severe
TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial
The primary efficacy objective is to determine whether a TAVI procedure performed by experienced operators in centers without on-site cardiac surgery is noninferior to TAVI procedure performed by the same operators in centers…
- Trial name
- TRACS (NCT05751577)
- Testing
- TAVI WITHOUT ON-SITE SURGERY, TAVI WITH ON-SITE SURGERY
- Where
- 14 sites in Italy
- Volunteers
- 657 people
- Sponsor
- Azienda Usl di Bologna
Aortic Stenosis, Brain Infarction
Neuroprotection in Patients Undergoing Aortic Valve Replacement
To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).
- Conditions
- Aortic Stenosis, Brain Infarction, Cerebrovascular Accident, Stroke
- Trial name
- NCT02389894
- Testing
- Embol-X Embolic Protection Device, CardioGard Cannula
- Where
- 18 sites in United States, Canada
- Volunteers
- 383 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Aortic Stenosis, Sedation Complication
High Flow Nasal Oxygen Cannula in Transcatheter Aortic Valve Replacement: Complications and Biomarkers
Background Transcatheter aortic valve replacement is a risky procedure, performed in patients that can also be considered at risk of developing complications.
- Trial name
- HIGH-OXY-TAVR (NCT05958537)
- Testing
- High flow nasal oxygen
- Where
- Spain
- Volunteers
- 132 people
- Sponsor
- Hospital Clinic of Barcelona
Aortic Valve Disease, Aortic Valve Stenosis
Evaluation of the Inflammatory Response in Post-operated Aortic Valve Replacement Patients.
Background Calcification of the aortic valve affects more than 26% of adult patients over 65 years of age and is the main indication for valve replacement in the United States of America.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification, Prosthetic Valve Malfunction
- Trial name
- NCT04557345
- Testing
- Determination of cytokines, Two-dimensional transthoracic echocardiogram
- Where
- Mexico
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
Critical Aortic Stenosis
THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.
- Trial name
- PARTNER (NCT00530894)
- Testing
- Edwards SAPIEN Transcatheter Heart Valve, Surgical Valve Replacement, medical management and/or balloon aortic valvuloplasty
- Where
- 26 sites in United States, Canada and 1 more
- Volunteers
- 1,057 people
- Sponsor
- Edwards Lifesciences
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