Clinical trials: Aortic Valve Stenosis, open to volunteers
Aortic Stenosis
Anatomical Determinants and Outcomes of Small Annulus Patients Undergoing TAVR in Different ASIAN Ethnicity
Transcatheter aortic valve implantation (TAVI) presents unique challenges for Asian patients compared to Caucasians, largely due to the prevalence of small aortic annulus (SAA) defined based on Caucasians' data (430 mm²)…
- Trial name
- NCT07240025
- Where
- Hong Kong
- Volunteers
- 31 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
Aortic Stenosis Treated With TAVI, Aortic Diseases
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The objective of this study is to compare the safety and effectiveness of the F2 Cerebral Protection System (CPS) to a standard of care control group in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR)
- Trial name
- SHIELD (NCT06689839)
- Testing
- F2 Filter and Delivery System, Transcatheter Aortic Valve Replacement (TAVR)
- Where
- 10 sites in United States, Australia
- Volunteers
- 500 people
- Sponsor
- EnCompass Technologies, Inc.
Aortic Stenosis, Gut Microbiome
Impact of Transcatheter Aortic Valve Implantation (TAVI) on the Gut Microbiota in Patients With Aortic Valve Stenosis
This study investigates the impact of transcatheter aortic valve implantation (TAVI) on the composition and function of the gut microbiota in patients with severe aortic valve stenosis.
- Conditions
- Aortic Stenosis, Gut Microbiome, Gut Microbiota, TAVI
- Trial name
- GUT-TAVI (NCT07052071)
- Testing
- TAVI
- Where
- Greece
- Volunteers
- 40 people
- Sponsor
- Hippocration General Hospital
Aortic Stenosis, Trans-catheter Aortic Valve Implantation
Optimization of Commissural Alignment During Transcatheter Aortic Valve Implantation With Evolut FX+
Purpose of the Study The purpose of this study is to investigate how a transcatheter aortic valve (TAVI, biological valve prosthesis) can best be positioned in order to avoid blockage of the coronary arteries by the valve…
- Conditions
- Aortic Stenosis, Trans-catheter Aortic Valve Implantation, Commissural Alignment
- Trial name
- ALIGN-EFX (NCT07217691)
- Testing
- Implantation of Evolut FX pluss TAVI device from Medtronic in LAO 25, Implantation of Evolut FX pluss TAVI device from Medtronic in patient specific degree.
- Volunteers
- 40 people
- Sponsor
- Oslo University Hospital
TAVI(Transcatheter Aortic Valve Implantation), Conduction Disorder
Biomarkers of Inflammation and Fibrosis in Conduction Disorders After TAVI
Prediction of conduction disorders (CDs) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) is an important and complex process with a significant impact on patient outcomes.
- Conditions
- TAVI(Transcatheter Aortic Valve Implantation), Conduction Disorder, Aortic Stenosis, Permanent Pacemaker Implantation
- Trial name
- NCT07201363
- Testing
- Biomarkers of inflammation and fibrosis in pre-procedural serum blood samples, Transthoracic echocardiography with myocardial deformation analysis and staging according to the extent of cardiac damage related to AS
- Where
- Croatia
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Clinical Hospital Center Rijeka
Aortic Stenosis, Bicuspid Aortic Valve (BAV)
TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis
To evaluate the safety and effectiveness of the Transcatheter aortic valve and retrievable delivery system (VitaFlow Liberty®) for the treatment of severe bicuspid aortic valve (BAV) stenosis.
- Trial name
- PROMIS-BAV (NCT06597188)
- Testing
- VitaFlow Liberty, Commercially available surgical bioprosthetic valve
- Where
- China
- Volunteers
- 452 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Aortic Stenosis
Preventing Hypoxia in Sedated TAVI: SuperNO₂VA vs. Conventional Oxygen
With increasing life expectancy, the geriatric population continues to grow. According to the Turkish Statistical Institute (TÜİK), the average life expectancy in Turkey between 2021 and 2023 is 77.3 years.
- Trial name
- NCT07006064
- Testing
- SUPERNOVA, NASAL MASK
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Ankara Bilkent Sehir Hastanesi
Severe Aortic Valve Stenosis
VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease
This prospective, randomized-controlled multicenter study investigates whether virtual reality-assisted patient education in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) can improve patient…
- Trial name
- VRAP-Heart (NCT05552352)
- Testing
- Virtual Reality assisted information
- Where
- 2 sites in Germany
- Volunteers
- 300 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Aortic Valve Stenosis
Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the VitaFlow Liberty® Flex Transcatheter Aortic Valve Delivery System for the Treatment of Severe Aortic Stenosis Lesions
This is a prospective, multicenter, randomized controlled clinical study designed to evaluate the real-world performance of the VitaFlow Liberty® Flex Transcatheter Aortic Valve Retrievable and Steerable Delivery System…
- Trial name
- Flex-TAVR (NCT07145463)
- Testing
- Transcatheter Aortic Valve Replacement
- Where
- China
- Volunteers
- 232 people
- Sponsor
- Shanghai Zhongshan Hospital
Aortic Valve Stenosis, Heart Valve Diseases
Antagonization of Heparin With Protamine Sulfate After TAVI
Transcatheter aortic valve replacement (TAVR) is now the first therapeutic option offered to high and intermediate risk patients with symptomatic aortic stenosis but even to low-risk, when the aortic valve is tricuspid and the…
- Trial name
- ATLANTIS-Prota (NCT06215378)
- Testing
- Antagonization of heparin with protamine sulfate
- Where
- France
- Volunteers
- 940 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
AORTIC VALVE DISEASES, Aortic Valve Stenosis and/or Insufficiency
Evaluation of Safety and Effectiveness of the EMBLOK EPS Compared With No Cerebral Embolic Protection During TAVR
The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with TAVR without embolic protection (unprotected TAVR).
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and/or Insufficiency, Aortic Valve Regurgitation, Aortic Valve Replacement
- Trial name
- EMBLOK II (NCT07129421)
- Testing
- EMBLOK™ Embolic Protection System ("EMBLOK EPS")
- Volunteers
- 560 people
- Sponsor
- Emblok, Inc.
Heart Valve Diseases, Aortic Valve Stenosis
CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.
The goal of this interventional, single-center study is to demonstrate if there is a change in the coronary ostia height after surgical aortic valve replacement and if it depends on the type of prosthesis or surgical technique…
- Conditions
- Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency, Regurgitation, Aortic
- Trial name
- CORONATE (NCT05714293)
- Testing
- CT scan with contrast medium
- Where
- Italy
- Volunteers
- 90 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
AORTIC VALVE DISEASES, Aortic Valve Stenosis
Clinical Investigation for the PoliaValve Aortic Heart Valve- India
The purpose of this study is to conduct a clinical investigation of the HeartHill PoliaValve Aortic Valve to collect evidence on the device's safety and performance.
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis, Aortic Valve Regurgitation
- Trial name
- NCT07123766
- Testing
- PoliaValve (Aortic)
- Volunteers
- 50 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Kidney Transplant, Familial Hypercholesterolaemia
Cardiovascular Risk in Children With Chronic Conditions Study
Children living with chronic health conditions face a higher risk of developing cardiovascular diseases than their peers, largely due to the accelerated aging of the heart and blood vessels.
- Conditions
- Kidney Transplant, Familial Hypercholesterolaemia, Type 1 Diabetes Mellitus (T1DM), Type 2 Diabetes Mellitus (T2DM)
- Trial name
- CR3C (NCT07086989)
- Where
- 3 sites in Hungary
- Volunteers
- 300 people
- Sponsor
- Semmelweis University
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 DISEASES, Mitral Valve Disease
Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve
The goal of this clinical trial is to explore the early feasibility, initial safety, and efficacy of surgical implantation of a polymer prosthetic heart valve in patients requiring either mitral valve replacement or aortic valve…
- Conditions
- AORTIC VALVE DISEASES, Mitral Valve Disease, Aortic Stenosis, Aortic Regurgitation
- Trial name
- POLYVALVE-FIH (NCT07097740)
- Testing
- Polymer Prosthetic Heart Valve
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Mitrassist Lifesciences Limited Co., Ltd.
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, Cerebral Ischaemic Injury
Perioperative Intensive Statin Therapy for Neuroprotection in TAVR（PISTNT）
Transcatheter aortic valve replacement (TAVR) has become the most anticipated treatment method in the cardiovascular field in recent years, experiencing rapid development.
- Trial name
- PISTNT (NCT07087379)
- Testing
- Intensive statin treatment
- Volunteers
- 500 people
- Sponsor
- Pan Xiangbin
Aortic Stenosis, Coronary Artery Disease
Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement
Patients undergoing transcatheter aortic valve replacement (TAVR) often have concomitant coronary artery disease (CAD) which may adversely affect prognosis.
- Conditions
- Aortic Stenosis, Coronary Artery Disease, Coronary Stenosis
- Trial name
- COMPLETE TAVR (NCT04634240)
- Testing
- Percutaneous Coronary Intervention (PCI)
- Where
- 72 sites in United States, Canada
- Volunteers
- 4,000 people
- Sponsor
- University of British Columbia
Heart Valve Diseases, Aortic Valve Stenosis
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Valvular heart disease (VHD) is a growing public health concern globally, with increasing disease burden and rising interest in advanced treatment strategies such as transcatheter interventions.
- Conditions
- Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- NCT07068633
- Where
- South Korea
- Volunteers
- 30,000 people
- Sponsor
- Yonsei University