Clinical trials: Stenosis, Aortic
Aortic Stenosis
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe…
- Trial name
- REPRISE III (NCT02202434)
- Testing
- Lotus Valve System, CoreValve/Evolut R Transcatheter Aortic Valve Replacement System, LOTUS Edge Valve System
- Where
- 58 sites in United States, Australia and 4 more
- Volunteers
- 1,425 people
- Sponsor
- Boston Scientific Corporation
Symptomatic Severe Aortic Stenosis
FlexNav EU CE Mark Study
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic…
- Trial name
- NCT03724812
- Testing
- Portico Valve and FlexNav™ Delivery System
- Where
- 6 sites in Denmark, Italy and 2 more
- Volunteers
- 46 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis
RESPOND Post Market Study
The purpose of the RESPOND post market study is to collect real world clinical and device performance outcomes data with the Lotus Valve System used in routine clinical practice to demonstrate that the commercially available…
- Trial name
- RESPOND (NCT02031302)
- Testing
- Lotus Valve System
- Where
- 41 sites in Colombia, Finland and 11 more
- Volunteers
- 1,064 people
- Sponsor
- Boston Scientific Corporation
Aortic Stenosis
TAVR Without Predilatation
The procedure is performed via transfemoral or transcaprotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon…
- Trial name
- TAVIWOP (NCT04350658)
- Testing
- Transcatheter aortic valve implantation required for symptomatic aortic stenosis
- Where
- France
- Volunteers
- 138 people
- Sponsor
- University Hospital, Montpellier
Aortic Stenosis, Hypo-attenuated Leaflet Thickening
The HALT Biomarker Study
The purpose of the HALT Biomarkers study are to identify a panel of circulating proteins that discriminates between patients with and without Hypo-Attenuated Leaflet Thickening (HALT) and can be used to supplement the diagnosis…
- Conditions
- Aortic Stenosis, Hypo-attenuated Leaflet Thickening, Bioprosthetic Valve Degeneration
- Trial name
- HALT (NCT04552275)
- Testing
- Proteomics Analysis
- Where
- 3 sites in United States
- Volunteers
- 300 people
- Sponsor
- Massachusetts General Hospital
Aortic Valve Stenosis
Anticoagulant Versus Dual Antiplatelet Therapy for Preventing Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement
This trial is to compare the efficacy of NOAC(Novel Oral Anticoagulants) with edoxaban vs. dual antiplatelet therapy (DAPT) for prevention of leaflet thrombosis (documented by cardiac CT imaging) and cerebral embolization…
- Trial name
- ADAPT-TAVR (NCT03284827)
- Testing
- NOAC, DAPT
- Where
- 5 sites in Hong Kong, South Korea and 1 more
- Volunteers
- 235 people
- Sponsor
- Duk-Woo Park, MD
Aortic Valve Stenosis
Comparison of Transaxillary and Transfemoral Fully-percutaneous Approaches for Transcatheter Aortic Valve Implantation
Retrospective, observational study to compare the outcomes of patient receiving TAVI through transfemoral and transaxillary fully percutaneous approach adjusting for main baseline differences.
- Trial name
- TRANSAX (NCT04274751)
- Testing
- Transcatheter aortic valve implantation
- Where
- Spain
- Volunteers
- 75 people
- Sponsor
- Ignacio J. Amat Santos
Aortic Valve Stenosis
A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve
The purpose of this study is the evaluation of the performance, safety and efficacy of Hydra Aortic valve in real-world patients.
- Trial name
- NCT02434263
- Testing
- Hydra TAVI
- Where
- 6 sites in Greece, Hong Kong and 4 more
- Volunteers
- 165 people
- Sponsor
- Vascular Innovations Co. Ltd.
Aortic Valve Disease
CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve
The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic stenosis.
- Trial name
- NCT02458560
- Testing
- Edwards CENTERA Self-Expanding Transcatheter Heart Valve
- Where
- 27 sites in Australia, Denmark and 7 more
- Volunteers
- 203 people
- Sponsor
- Edwards Lifesciences
Calcific Aortic Stenosis
Study Investigating the Effect of Drugs Used to Treat Osteoporosis on the Progression of Calcific Aortic Stenosis.
Aortic stenosis is a condition whereby one of the heart valves (aortic valve) becomes narrowed, due to calcium deposition, over time. This can lead to chest pain, heart failure and sudden death.
- Trial name
- SALTIRE II (NCT02132026)
- Testing
- Denosumab, Alendronic Acid
- Where
- United Kingdom
- Volunteers
- 152 people
- Sponsor
- University of Edinburgh
Aortic Valve Stenosis
Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation
The aim of the study is to evaluate the clinical efficacy of 2 different vascular closure device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI).
- Trial name
- CHOICE-CLOSURE (NCT04459208)
- Testing
- Manta, ProGlide
- Where
- Germany
- Volunteers
- 516 people
- Sponsor
- Helios Health Institute GmbH
Aortic Stenosis
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement (REPRISE Japan)
The objective of this study is to confirm the safety and effectiveness of the Lotus™ Valve System in the Japanese medical environment for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe…
- Trial name
- NCT02491255
- Testing
- Lotus Valve System
- Where
- 5 sites in Japan
- Volunteers
- 70 people
- Sponsor
- Boston Scientific Corporation
Symptomatic Aortic Stenosis
Image Fusion and Calcification Raising in Trans Aortic Valve Implantation
Aortic stenosis is one of the most common cardiology diseases. Trans aortic valve implantation (TAVI) has been developed since 2002, first to treat rejected patients from conventional surgery, then to treat high surgical risk…
- Trial name
- TAVI (NCT03247465)
- Testing
- Image Fusion
- Where
- France
- Sponsor
- Nantes University Hospital
Aortic Valve Stenosis
Metabolic Determinants of the Progression of Aortic Stenosis
Calcific aortic stenosis (AS) has become the most common cardiac disease after coronary artery disease and hypertension. Unfortunately no medical therapies have been proven to decrease either the progression of valve stenosis or…
- Trial name
- PROGRESSA (NCT01679431)
- Testing
- Doppler-echocardiography, Computed tomography, Magnetic resonance imaging
- Where
- Canada
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Laval University
Aortic Valve Stenosis
Multicenter Prospective Study of Low-Flow Low-Gradient Aortic Stenosis (TOPAS Study)
Low-flow, low-gradient (LF-LG) aortic stenosis (AS) may occur with depressed (i.e. Classical LF; CLF) or preserved (i.e. Paradoxical LF; PLF) LV ejection fraction (LVEF) and both situations are amongst the most challenging…
- Trial name
- NCT01835028
- Testing
- Echocardiography, Computed tomography, Magnetic resonance imaging
- Where
- 11 sites in United States, Austria and 4 more
- Volunteers
- 320 people
- Sponsor
- Laval University
Aortic Valve Stenosis, Coronary Artery Disease
Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI
Patients undergoing surgical aortic valve replacement (sAVR) with concomitant coronary artery disease (CAD) are known to have higher mortality rates compared to patients without CAD.
- Trial name
- NCT04385459
- Testing
- Coronary artery disease
- Where
- Sweden
- Volunteers
- 346 people
- Sponsor
- Örebro County Council
Aortic Valve Stenosis, Aortic Valve Calcification
SLOW-Slower Progress of caLcificatiOn With Vitamin K2
A randomized 12-month trial will include two groups of 100 individuals aged over 50 years, with asymptomatic mild to moderate Aortic valve stenosis (AVA > 1 cm2, Vmax < 4 m/s).
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Mitral Annular Calcification, Mitral Valve Calcification
- Trial name
- NCT04429035
- Testing
- Vitamin K2
- Where
- 2 sites in Greece
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- National and Kapodistrian University of Athens
Aortic Valve Stenosis
Assessment of Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small Insertable Cardiac Monitoring Device
Transcatheter aortic valve implantation (TAVI) has emerged as a valuable minimal-invasive treatment option in patients with symptomatic severe aortic valve (AV) stenosis at prohibitive or increased risk for conventional…
- Trial name
- Reveal (NCT02559011)
- Where
- Switzerland
- Volunteers
- 100 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Transcatheter Aortic Valve Replacement, Lung Ultrasound
LUS in Aortic Stenosis Patients Undergoing TAVR
1. Introduction and aims: Transcatheter aortic valve replacement (TAVR) is the gold standard for the treatment of elderly patients with severe aortic valve stenosis (AS).
- Conditions
- Transcatheter Aortic Valve Replacement, Lung Ultrasound, Severe Aortic Valve Stenosis, Pulmonary Congestion
- Trial name
- NCT05024942
- Testing
- Transfemoral TAVR (Transcatheter aortic valve replacement)
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Catholic University of the Sacred Heart
Aortic Valve Stenosis, Coronary Artery Disease
Registry to Gather Long-time Results After Surgical Aortic Valve Replacement With a "Rapid Deployment Aortic Valve Prothesis (Edwards Intuity) Combined With Bypss Surgery (CABG)
This is a prospctive, unrandomized multicentric registry which will enrol patients with an indication for aortc valve replacement combined with myocardial reperfusion (CABG).
- Trial name
- INCA (NCT03326778)
- Testing
- AVR and CABG
- Where
- Germany
- Volunteers
- 220 people
- Sponsor
- Campus Bad Neustadt