Clinical trials: Aortic Stenosis
Severe Aortic Stenosis
Safety and Performance Study of the Optimum Transcatheter Aortic Valve
The TAVI (Thubrikar Aortic Valve, Inc.) -1 Study: Safety and Performance Study of the Optimum Transcatheter Aortic Valve- First-in-human study to assess feasibility and safety of the Optimum Aortic Valve Implant
- Trial name
- NCT04076150
- Testing
- Transcatheter Aortic Valve (TAV) Implantation With The Optimum TAV System
- Where
- Poland
- Volunteers
- 5 people
- Sponsor
- Thubrikar Aortic Valve, Inc.
Hypertrophic Cardiomyopathy
Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy
The main objective of the study is to improve implantable cardioverter defibrillator (ICD) implantation decision-making processing relevance by developing a new prediction model of sudden cardiac death (SCD) in hypertrophic…
- Trial name
- OPTIM-HCM (NCT03846297)
- Where
- France
- Volunteers
- 2,000 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Aortic Valve Stenosis, Limited Access Aortic Valve Replacement
Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement
The LIAR-Trial is a single-center, single blind randomized controlled clinical trial comparing patients undergoing isolated AVR via J-shaped upper hemi-sternotomy (UHS) and conventional AVR through a full median sternotomy (FMS).
- Conditions
- Aortic Valve Stenosis, Limited Access Aortic Valve Replacement, Quality of Life
- Trial name
- LIAR (NCT04012060)
- Testing
- Limited access aortic valve replacement., Conventional aortic valve replacement
- Where
- Netherlands
- Volunteers
- 161 people
- Sponsor
- St. Antonius Hospital
Aortic Stenosis
TAVI Without On-Site Cardiac Surgery in Poland: A Randomized Multicenter Trial Protocol
Aortic stenosis (AS) represents the most prevalent acquired valvular heart disease in European populations, and transcatheter aortic valve implantation (TAVI) has become the dominant treatment modality for patients with…
- Trial name
- NOSCAR-TAVI (NCT07515768)
- Testing
- transcathter aortic valve implantation
- Volunteers
- 404 people
- Sponsor
- Medical University of Warsaw
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 Aneurysm, Iliac Aneurysm
Comparison of Aorto-iliac Endovascular Interventions With and Without the EndoNaut Workstation
The aim of this retrospective, multicenter study is to demonstrate that the use of EndoNaut for aortoiliac endovascular procedures has a clinical impact for the patient (reduction in irradiation and the volume of contrast…
- Conditions
- Aortic Aneurysm, Iliac Aneurysm, Stenoses, Aortic, Iliac Artery Stenosis
- Trial name
- COM-ENDO (NCT04714268)
- Testing
- Aorto-iliac endovascular procedure
- Where
- France
- Volunteers
- 150 people
- Sponsor
- Therenva
Bicuspid Aortic Valve
BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.
Prospective non interventional, observational registry of 150 patients undergoing TAVI with Evolut platform for bicuspid aortic stenosis.
- Trial name
- BIVOLUTX (NCT03495050)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- France
- Volunteers
- 150 people
- Sponsor
- Clinique Pasteur
Aortic Stenosis, Heart Failure
Semaglutide in Patients Undergoing Transcatether Aortic Valve Replacement
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating the safety and efficacy of once-weekly semaglutide 2.4 mg in adult patients undergoing transcatheter aortic valve…
- Trial name
- REVERSE-TAVR (NCT07090343)
- Testing
- Wegovy ®
- Volunteers
- 826 people
- Sponsor
- Leiden University Medical Center
Aortic Stenosis
Effect of Steroids on Cerebral Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement
The purpose of this study is to investigate if methylprednisolone is effective in reducing the cerebral inflammatory response after open heart surgery with cardiopulmonary bypass.
- Trial name
- NCT01755338
- Testing
- Methylprednisolone
- Where
- Sweden
- Volunteers
- 30 people
- Sponsor
- Sahlgrenska University Hospital
Aortic Valve Stenosis
Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population
To confirm the safety and efficacy of the Lotus™ Valve System in the Chinese population for Transcatheter Aortic Valve Implantation (TAVI) in symptomatic patients with severe aortic stenosis.
- Trial name
- LOTUS-CHINA (NCT02536703)
- Testing
- Lotus Valve System
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Bypass Complication, Cardioplegia Solution Adverse Reaction
Investigation of Myocardial Protection Level With Specific Cardioplegia Methods in Cardiac Surgery
Investigating the myocardial effects of cold blood cardioplegia and del nido cardioplegia solution, which are routinely used in clinical practice, will contribute to the studies in the literature on the safety and efficacy of…
- Conditions
- Bypass Complication, Cardioplegia Solution Adverse Reaction, Endothelial Degeneration, Oxidative Stress
- Trial name
- NCT05603429
- Testing
- Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status
- Where
- Turkey (Türkiye)
- Volunteers
- 74 people
- Sponsor
- Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Hypertrophic Cardiomyopathy (HCM), Cardiomyopathy
Large Language Models To Improve the Quality of Care of Cardiology Patients
This study evaluates the impact of large language models (LLMs) versus traditional decision support tools on clinical decision-making in cardiology.
- Conditions
- Hypertrophic Cardiomyopathy (HCM), Cardiomyopathy, Genetic Disease, Cardiology
- Trial name
- NCT06935253
- Testing
- Large Language Model
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Stanford University
Aortic Stenosis, Aortic Regurgitation
Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease
To compare changes in Left Ventricular Mass (LVM) depending on each blood pressure regulation between the intensive care group and the usual care group for patients with hypertension accompanied by aortic valve disease and…
- Conditions
- Aortic Stenosis, Aortic Regurgitation, Hypertension, LVM
- Trial name
- NCT03666351
- Testing
- Amlodipine 5mg, Losartan, Losartan and Amlodipine
- Where
- South Korea
- Volunteers
- 128 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Acute Ischemic Stroke, Acute Renal Injury
Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Acute Ischemic Cerebral and Renal Events After Transcatheter Aortic Valve Implantation
The aim of this trial is to assess the safety and efficacy of conestat alfa (Ruconest®, Pharming Technologies B.V.) on renal and cerebral ischemic events in patients undergoing TAVI for severe symptomatic aortic stenosis (AS)…
- Trial name
- PAIR-TAVI (NCT05145283)
- Testing
- Conestat alfa (Ruconest®), NaCl 0.9%)
- Where
- 2 sites in Switzerland
- Volunteers
- 141 people
- Sponsor
- University Hospital, Basel, Switzerland
Aorta Aneurysm, Aorta Dissection
Spanish Percutaneous Aortic INtervention REGISTRY (SPAIN REGISTRY)
Multicentre prospective registry including consecutive patients undergoing Percutaneous Endovascular Aneurysm Repair (PEVAR), Percutaneous Endovascular Thoracic Aneurysm Repair (PTEVAR) or Transcatheter Aortic Valve Implantation…
- Conditions
- Aorta Aneurysm, Aorta Dissection, Aorta Stenosis, Aortic Coarctation
- Trial name
- SPAIN (NCT04307888)
- Testing
- Perclose Proglide (Abbott)
- Volunteers
- 600 people
- Sponsor
- Sociedad Espanola de Angiologia y Cirugia Vascular
Severe, Symptomatic
The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.
- Conditions
- Severe, Symptomatic, Calcific Aortic Stenosis
- Trial name
- PARTNERII B (NCT02184442)
- Testing
- TAVR Implantation with SAPIEN XT, TAVR Implantation with SAPIEN
- Where
- 53 sites in United States
- Volunteers
- 560 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Detecting Changes in Arterial Blood Volume and Cardiac Efficiency
The objective of this Pilot Study is to demonstrate the efficacy of the Hemocept device in detecting changes in arterial blood volume and cardiac efficiency.
- Trial name
- NCT07205341
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- HemoCept Inc.
Cardiovascular Diseases, Heart Diseases
Logical Analysis of Data and Cardiac Surgery Risk
To use a new statistical method, the Logical Analysis of Data (LAD), to predict cardiac surgery risk.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Aortic Valve Stenosis
- Trial name
- NCT00081666
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Aortic Valve Stenosis
The Leaflex™ Standalone Study Protocol
A prospective, multicenter, single-arm study aimed to assess safety and performance of the Leaflex™ Performer in the treatment of patients with symptomatic, severe aortic stenosis.
- Trial name
- NCT04649099
- Testing
- Leaflex™ Performer
- Where
- Hungary
- Volunteers
- 33 people
- Sponsor
- Pi-cardia
Rheumatic Heart Disease, Acute Rheumatic Fever
Rheumatic Heart Disease in Peru: Prevalence and Cardiovascular Outcomes Among Schoolchildren
Rheumatic heart disease remains a major challenge in low and middle income countries. Early detection of clinically silent valvular lesions by screening echocardiography allows timely implementation of secondary antibiotic…
- Trial name
- NCT02353663
- Testing
- Echocardiography
- Where
- 2 sites in Peru, Switzerland
- Volunteers
- 1,023 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
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