Clinical trials: Aortic Valve Stenosis, open to volunteers
Severe Aortic Valve Stenosis
ULTRA-EVOLUT RCT: A Comparison of Latest-Generation TAVR Valves
Title: The ULTRA-EVOLUT Randomized Control Trial: A Head-to-Head Comparison of Latest-Generation Transcatheter Aortic Valves Brief Summary: The goal of this clinical trial is to compare the latest-generation balloon-expandable…
- Trial name
- TAVR (NCT07545369)
- Testing
- SAPIEN 3 Ultra Resilia, Evolut FX
- Where
- Egypt
- Volunteers
- 200 people
- Sponsor
- Assiut University
Aortic Stenosis, TAVI
Echo-Guided vs Fluoroscopy-Guided Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis（ECHO-TAVR）
Aortic stenosis (AS) is a common valvular heart disease whose prevalence increases markedly with age-approximately 2-4% in individuals aged 65 years and older, and up to 3.4% for severe AS in those over 75.
- Conditions
- Aortic Stenosis, TAVI, TAVI(Transcatheter Aortic Valve Implantation)
- Trial name
- ECHO-TAVR (NCT07317804)
- Testing
- Echocardiographic guidance, Fluoroscopic guidance
- Where
- China
- Volunteers
- 212 people
- Sponsor
- China National Center for Cardiovascular Diseases
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
COronary Re-engageMent aFter randOm NavitoR alignmenT (COMFORT STUDY)
Whereas PCI before TAVR was previously recommended despite its uncertain prognostic role, recent data underline the possibility of a postponed coronary intervention using a commissural alignment technique.
- Trial name
- COMFORT (NCT05779787)
- Testing
- TAVR Aligned, TAVR Random
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Niguarda Hospital
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Ischemic And Bleeding Risk Assessment After TAVR
Transcatheter aortic valve replacement (TAVR) represents an effective treatment to improve symptoms and prognosis in patients with symptomatic severe aortic stenosis (AS) (1-2).
- Trial name
- FOCUS ONE (NCT06000943)
- Testing
- Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT
- Where
- 12 sites in Belgium, Chile and 3 more
- Volunteers
- 2,500 people
- Sponsor
- Niguarda Hospital
Aortic Diseases
INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis
This clinical investigation is being done to evaluate the safety and effectiveness of a new device, a PTV Balloon, that will be used to open up an area in the heart (the valve) before and potentially after placing a new valve in…
- Trial name
- NCT06816485
- Testing
- PTV (Percutaneous Transcatheter Valvuloplasty) Balloon
- Where
- 9 sites in Spain
- Volunteers
- 93 people
- Sponsor
- Biosensors Europe SA
Valve Disease, Aortic, Mitral Regurgitation (MR)
DELINEATE-Prospective
Heart disease is the leading cause of death in the United States, and echocardiography (or "echo") is the most common way doctors look at the heart.
- Conditions
- Valve Disease, Aortic, Mitral Regurgitation (MR), Aortic Stenosis, Valvular Heart Disease
- Trial name
- DELINEATE (NCT07197736)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
Severe Aortic Stenosis
CLEAR-AS: CT-FFR-Guided Revascularization in Patients With Severe Aortic Stenosis
Severe aortic stenosis (AS) is often accompanied by coronary artery disease (CAD). While coronary computed tomography angiography (CCTA) is routinely used before aortic valve replacement (AVR) to evaluate coronary anatomy, it…
- Trial name
- CLEAR-AS (NCT07469371)
- Testing
- CCTA plus CT-FFR-informed preoperative decision strategy, CCTA-guided preoperative decision strategy
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Yan'an Affiliated Hospital of Kunming Medical University
Aortic Valve Disease, Aortic Stenosis, Severe
Valvosoft Outcomes Registry for Real-World Evidence
The VALvosoft Outcomes Registry for Real-World Evidence (VALOR-PMCF) is a prospective, multicenter, single-arm post-market clinical follow-up (PMCF) registry designed to evaluate the long-term safety and effectiveness of the…
- Conditions
- Aortic Valve Disease, Aortic Stenosis, Severe, Aortic Valve Calcification, Ultrasound Therapy
- Trial name
- VALOR-PMCF (NCT07520591)
- Testing
- Valvosoft Treatment
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Cardiawave SA
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.
Symptomatic Severe Native Aortic Stenosis, Aortic Stenosis
STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)
To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.
- Trial name
- NCT07278310
- Testing
- TAVR Device, Siegel TAVR Device
- Where
- United States
- Volunteers
- 1,025 people
- Sponsor
- MiRus
Sleep-disordered Breathing (SDB), Aortic Valve Stenosis
Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing
This prospective observational study aims to investigate the impact of transcatheter aortic valve implantation (TAVI) and transcatheter mitral valve edge-to-edge repair (M-TEER) on sleep-disordered breathing (SDB) in patients…
- Conditions
- Sleep-disordered Breathing (SDB), Aortic Valve Stenosis, Mitral Valve Regurgitation
- Trial name
- SLEEP-VALVE (NCT07520656)
- Where
- Greece
- Volunteers
- 150 people
- Sponsor
- Aristides Plaitis
Low Flow, Low Gradient Aortic Stenosis
Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis
LOW-TAVR is a real-world, retrospective and prospective, multicenter Italian registry aimed at evaluating the characteristics and clinical outcomes of patients with severe low flow, low gradient aortic stenosis undergoing…
- Trial name
- LOW-TAVR (NCT06589063)
- Testing
- Transcatheter aortic valve replacement
- Where
- Italy
- Volunteers
- 1,350 people
- Sponsor
- University of Salerno
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
Aortic Stenosis
PRessure-based Evaluation of Disease Improvement in the Course of TAVI
The goal of this prospective observational study is to learn if advanced heart pressure wave analysis (using methods called WIA and REPA) can help predict the success of the procedure and long-term recovery in adults (aged 60-90)…
- Trial name
- PREDIC-TAVI (NCT07509554)
- Testing
- Transcatheter aortic valve replacement (TAVR / TAVI)
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Aortic Stenosis, Calcific
PCSK9 Inhibitors in the Treatment of Calcific Aortic Stenosis
Calcific aortic stenosis (CAS) can cause severe adverse cardiac events, but there are currently no effective drugs that can prevent or delay the progression of the disease.
- Trial name
- PICASO (NCT07256197)
- Testing
- Treatment with PCSK9 inhibitors, Treatment without PCSK9 inhibitors
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Beijing Anzhen Hospital
Coronary Artery Disease, Aortic Valve Stenosis
MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)
MiECS is one of the largest multicentre randomised controlled trials on extracorporeal circulation conducted under the auspices of Minimal Invasive Extracorporeal Technologies International Society (MiECTiS).
- Conditions
- Coronary Artery Disease, Aortic Valve Stenosis, Extracorporeal Circulation; Complications
- Trial name
- MiECS (NCT05487612)
- Testing
- Minimal Invasive Extracorporeal Circulation, Conventional cardiopulmonary bypass
- Where
- 13 sites in Canada, Germany and 4 more
- Volunteers
- 1,300 people
- Sponsor
- Aristotle University Of Thessaloniki
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
The issue of valve durability has become one of the most important aspects in the TAVR field in recent years since transcatheter aortic valve replacement has been progressively applied to younger patients with a low co-morbidity…
- Trial name
- NCT06420830
- Testing
- SAPIEN 3 Ultra RESILIA Valve
- Where
- Canada
- Volunteers
- 150 people
- Sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Aortic Valve Stenosis, Aortic Valve Regurgitation
Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR
Data on valve performance following ViV-TAVR has usually been obtained with the use of Doppler-echocardiography. However, some reports have shown significant discordances in the evaluation of mean transvalvular gradient between…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Regurgitation, Prosthesis Failure
- Trial name
- ECHOCATH (NCT05459233)
- Testing
- Doppler-echocardiography, Invasive hemodynamic measurements
- Where
- 7 sites in United States, Canada
- Volunteers
- 310 people
- Sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Aortic Valve Stenosis
Observational Study to Collect Data of Patient Which Recieving a TAVI in TAVI Procedure
Patients with aortic valve stenosis often undergo transcatheter aortic valve implantation (TAVI) today. This biological valve can wear out or leak over time.
- Trial name
- REDO-TAVI (NCT07215143)
- Volunteers
- 300 people
- Sponsor
- IHF GmbH - Institut für Herzinfarktforschung
Left Ventricle Function, Transcatheter Aortic Valve Replacement (TAVR)
Phenotyping Left Ventricle Failure With Hemodynamic Biomarkers From 4D Flow Magnetic Resonance Imaging
This study aims to enhance and streamline intracardiac 4D Flow magnetic resonance imaging (MRI) processing by increasing automation for the quantitative and systematic assessment of left ventricular (LV) dysfunction.
- Conditions
- Left Ventricle Function, Transcatheter Aortic Valve Replacement (TAVR), Aortic Valve Stenosis
- Trial name
- TRANSLATE (NCT07455292)
- Testing
- Cardiac MRI with 4D Flow acquisition and invasive signal routinely collected during transcatheter aortic valve replacement
- Where
- 2 sites in Italy
- Volunteers
- 190 people
- Sponsor
- IRCCS Policlinico S. Donato