Clinical trials: TAVI
Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation)
Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion
The goal of this clinical trial is to discover if routine 'double tap' balloon post-dilation improves valve expansion and clinical outcomes in adults undergoing Transcatheter Aortic Valve Implantation (TAVI) with the SAPIEN…
- Trial name
- ACE-DOUBLE (NCT07430267)
- Testing
- 'Double tap' balloon post-dilation
- Where
- 3 sites in Australia
- Volunteers
- 250 people
- Sponsor
- The Alfred
Aortic Stenosis Treated With TAVI
Zhicheng TAVR Robot
Use of the Transcatheter Aortic Valve Replacement Surgical Assist System and its Disposable Kit in Patients With Severe Aortic Stenosis to Evaluate the Safety and Efficacy of the Transcatheter Aortic Valve Replacement Surgical…
- Trial name
- NCT07392359
- Testing
- TAVR Assistance System, TAVR by manual
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Zhicheng Medical Technology (Jiaxing) Co, Ltd
Aortic Valve Stenosis, Iron Deficiency
Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation
The aim of the open-label, randomized controlled superiority IRON TAVI trial is to investigate whether intravenous iron therapy (ferric carboxymaltose) improves Health-Related Quality of Life (HRQOL) in patients with severe…
- Conditions
- Aortic Valve Stenosis, Iron Deficiency, TAVI(Transcatheter Aortic Valve Implantation), Cardiovascular Diseases
- Trial name
- IRON TAVI (NCT07370688)
- Testing
- Intravenous ferric carboxymaltose
- Where
- Netherlands
- Volunteers
- 402 people
- Sponsor
- Erasmus Medical Center
Aortic Valve Stenosis, TAVI(Transcatheter Aortic Valve Implantation)
Portuguese Registry With Meril Myval THV Series - MyPORTuVal Registry
A prospective, single-arm, multi-centre registry to evaluate the safety and performance of Myval THV series using Transcatheter Aortic Valve Implantation (TAVI) procedure in patients with symptomatic severe native aortic valve…
- Trial name
- MyPORTuVal (NCT06818435)
- Testing
- Myval THV series
- Where
- 6 sites in Portugal
- Volunteers
- 150 people
- Sponsor
- Portuguese Association of Interventional Cardiology
Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation)
Demographic and Interpopulation Variations in Evaluation and Results of TAVI
The aim of the project is to evaluate demographic, clinical, and laboratory variations in patients with aortic stenosis treated with TAVI in different countries.
- Conditions
- Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation), Computed Tomography, Inflammatory Response During Cardiac Surgery
- Trial name
- DIVER-TAVI (NCT07258706)
- Testing
- laboratory biomarker analysis, Computed tomography of aortic root and aorta
- Where
- 5 sites in Italy, Poland and 3 more
- Volunteers
- 800 people
- Sponsor
- Poznan University of Medical Sciences
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
Heart Valve Disease, TAVI
Enhanced Valves Interventions and Safe AI Generated End Results
This non-interventional study aims to use artificial intelligence to improve the prediction of transcatheter heart valve interventions and optimize patient outcomes.
- Conditions
- Heart Valve Disease, TAVI, M-TEER, TTVI
- Trial name
- ENVISAGE (NCT07213531)
- Testing
- Medical imaging analysis via artificial intelligence algorithms
- Where
- 15 sites in United States, Canada and 3 more
- Volunteers
- 21,000 people
- Sponsor
- Montreal Heart Institute
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
TAVI(Transcatheter Aortic Valve Implantation), TAVI
Quality of Life Improvement After TAVI (QualiTAVI-UK Trial)
Transcatheter aortic valve implantation (TAVI) has become an important therapeutic intervention for patients with symptomatic severe aortic stenosis (AS) who are at high surgical risk.
- Conditions
- TAVI(Transcatheter Aortic Valve Implantation), TAVI, Quality of Life, Mental Health
- Trial name
- QualiTAVI-UK (NCT07193004)
- Testing
- Quality of Life
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- University Hospital Plymouth NHS Trust
TAVI(Transcatheter Aortic Valve Implantation)
ROTAO 1 - Feasibility and Safety of the TAVIPILOT Tele-operated Robot During Transcatheter Aortic Valve Replacement (TAVR/TAVI)
The TAVIPILOT tele-operated robot by Caranx Medical is an advanced intraoperative robotic assistance system designed to enhance the precision of transcatheter aortic valve positioning during TAVR.
- Trial name
- NCT07152574
- Testing
- TAVR using a tele-operated Robot
- Volunteers
- 10 people
- Sponsor
- Caranx Medical
TAVI(Transcatheter Aortic Valve Implantation)
Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI) in Australia
The TAVIPILOT Software by Caranx Medical is an advanced intraoperative assistance tool designed to enhance the accuracy of transcatheter aortic valve positioning during TAVI.
- Trial name
- SAITO 1B (NCT07121907)
- Testing
- TAVR using a guidance software
- Volunteers
- 10 people
- Sponsor
- Caranx Medical
TAVI(Transcatheter Aortic Valve Implantation)
Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI)
The TAVIPILOT Software by Caranx Medical is an advanced intraoperative assistance tool designed to enhance the accuracy of transcatheter aortic valve positioning during TAVI.
- Trial name
- SAITO 1B (NCT07100340)
- Testing
- TAVR using a guidance software
- Volunteers
- 10 people
- Sponsor
- Caranx Medical
Stroke, Transcatheter Aortic Valve Replacement (TAVR)
A Clinical Study on the Use of the Sentinel Cerebral Protection Device During TAVR for the Prevention of Procedure-Related Stroke
After more than a decade of development, transcatheter aortic valve replacement (TAVR) is now a standard, guideline-recommended treatment for all symptomatic patients with severe aortic stenosis, regardless of their surgical…
- Conditions
- Stroke, Transcatheter Aortic Valve Replacement (TAVR), Aortic Stenosis Treated With TAVI
- Trial name
- SENTINEL-TAVR (NCT07045233)
- Testing
- Sentinel® Cerebral Protection System, MRI
- Where
- China
- Volunteers
- 200 people
- Sponsor
- China National Center for Cardiovascular Diseases
Aortic Stenosis Disease, TAVI(Transcatheter Aortic Valve Implantation)
Cerebral Regional Oxygen Saturation During TAVI - The CROS-TAVI Prospective Registry
This single-center, non-commercial clinical study investigates how different types of transcatheter aortic valve prostheses affect cerebral oxygen saturation during the procedure (TAVI - Transcatheter Aortic Valve Implantation).
- Conditions
- Aortic Stenosis Disease, TAVI(Transcatheter Aortic Valve Implantation), Cerebral Oxygen Saturation, Hemodynamic Changes
- Trial name
- CROS-TAVI (NCT07016789)
- Testing
- Near-infrared spectroscopy monitoring (NIRS) INVOS 5100C
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Trans-femoral TAVI With Calcified Ilio-femoral Arteries
TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI
To compare the effectiveness and the safety of femoral-iliac IVL versus balloon only PTA for successful deployment of transfemoral transcatheter aortic valve prosthesis.
- Trial name
- TRAFIC-PTA (NCT05873842)
- Testing
- Trans-femoral TAVI
- Where
- 5 sites in Italy
- Volunteers
- 50 people
- Sponsor
- Rede Optimus Hospitalar SA
Transcatheter Aortic Valve Implantation (TAVI), Aortic Valve Stenosis
Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)
The purpose of this study is to assess the feasibility and safety of the Transverse Medical, Inc. Point-Guard device. This feasibility study is a limited clinical investigation of the Point-Guard device.
- Conditions
- Transcatheter Aortic Valve Implantation (TAVI), Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
- Trial name
- GUARDIAN (NCT06962371)
- Testing
- cerebral embolic protection
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- Transverse Medical, Inc.
Severe Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation)
Observational Study Relating to the Long-term Follow-up of Patients with Severe Aortic Stenosis Evaluated for Percutaneous Aortic Valve Replacement (TAVI).
All patients with severe aortic stenosis undergoing evaluation for TAVI are routinely subjected to a series of assessments: Pre-implantation: thoraco-abdominal CT angiography, coronary angiography, echocardiography, clinical…
- Trial name
- ROARING-TAVI (NCT06679517)
- Testing
- TAVI
- Where
- Italy
- Volunteers
- 600 people
- Sponsor
- University Hospital of Ferrara
Aortic Stenosis, Multi Vessel Coronary Artery Disease
The TransCatheter Valve and Vessels Trial
The trial objective is to investigate whether Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention (PCI) and TransCatheter Aortic Valve Implantation (TAVI) strategy for treatment of multivessel disease and…
- Conditions
- Aortic Stenosis, Multi Vessel Coronary Artery Disease, TAVI, CABG
- Trial name
- TCW (NCT03424941)
- Testing
- FFR-guided PCI and TAVI, CABG and SAVR
- Where
- 20 sites in Austria, Denmark and 8 more
- Volunteers
- 172 people
- Sponsor
- Maatschap Cardiologie Zwolle
Patients Above 18 Years, Patient Discharge
One Year Pacing Dependency After TAVR
Pace maker implantation after the procedure of TAVR can be estimated at 15% of patients. However, some studies have shown that the conduction disturbances after TAVR could resolve over time, and that roughly between one- and…
- Conditions
- Patients Above 18 Years, Patient Discharge, Pacing Therapy, Aortic Stenosis (Treated With TAVI)
- Trial name
- PACETAVI (NCT06756282)
- Testing
- Pacemaker and defibrillator
- Where
- France
- Volunteers
- 90 people
- Sponsor
- University Hospital, Montpellier
Aortic Valve Disease, Transcatheter Aortic Valve Implantation
Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation
Despite Transcatheter aortic valve implantation (TAVI) evolution regarding techniques, equipment and experience, the need for permanent pacemaker implantation (PPI) post-TAVI remains an important drawback.
- Conditions
- Aortic Valve Disease, Transcatheter Aortic Valve Implantation, TAVI
- Trial name
- NCT06189976
- Testing
- Rapid atrial pacing
- Where
- 2 sites in Belgium, Greece
- Volunteers
- 400 people
- Sponsor
- National and Kapodistrian University of Athens