Clinical Research Directory

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. Degenerative calcific AS predominates in high-income countries, whereas rheumatic disease remains a major cause in low-income regions. With global population aging, the disease burden of AS continues to rise. Transcatheter aortic valve replacement (TAVR/TAVI), owing to its minimally invasive nature, has become an important treatment option for severe AS and selected aortic regurgitation patients, expanding from high-surgical-risk populations to those at intermediate and low risk. In recent years, the number of TAVR procedures in many regions has surpassed or approached that of surgical aortic valve replacement, and major clinical guidelines have elevated TAVR to a recommended standard therapy. Conventional TAVR relies on combined fluoroscopic and echocardiographic guidance. However, perioperative complications remain frequent in elderly and high-risk patients, particularly acute kidney injury (AKI), which significantly increases short- and long-term mortality. Contrast exposure during the procedure is a major contributor to AKI; thus, clinical practice increasingly favors strategies that minimize contrast use, such as low-dose and low-kV imaging. Elevated contrast concentration in the renal tubules increases viscosity, prolongs renal exposure, and can lead to tubular injury and renal dysfunction. Continuous radiation exposure during vascular access, device positioning, valve deployment, and post-release assessment also poses safety concerns for both patients and medical staff. Echocardiography-only guidance for TAVR has therefore emerged as an attractive alternative, with the potential to replace fluoroscopy and contrast for anatomical visualization and device positioning, thereby reducing radiation exposure and contrast-related kidney injury. However, no prospective randomized study has directly compared echocardiography-only guidance with conventional fluoroscopy-plus-echocardiography guidance, and current evidence remains preliminary. To address this gap, a randomized controlled trial was designed to evaluate whether echocardiography-only guidance is non-inferior to combined fluoroscopic and echocardiographic guidance in terms of device success, while also assessing the safety, efficacy, and clinical feasibility of both approaches.

SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation

The goal of this observational study is to document which LV-guidewires are used during a TAVI (Transcatheter Aortic Valve Implantation) procedure and how their different functions perform. A TAVI procedure is a minimally invasive treatment for aortic stenosis, where a new heart valve is inserted through a blood vessel in the groin. During this procedure, a wire (specifically, an LV-guidewire) is used to place the new heart valve. For this purpose, a regular LV-guidewire or a newer LV-guidewire with extra features, the Savvywire, can be used. All of these wires work well, are safe, and are already used in daily medical practice. Researchers will compare these LV-guidewires to see if the Savvywire adds additional value. Patients aged 50 or older who undergo a TAVI procedure via the femoral artery (blood vessel in the groin) can participate. Participants will receive the usual care and standard follow-up, only their data will be collected and analyzed.

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 balloon-expandable TAVI prosthesis. The primary hypothesis is that routine 'double tap' balloon post-dilation improves TAVI valve expansion. The secondary hypothesis is that routine 'double tap' balloon post-dilation improves TAVI valve haemodynamic performance. Participants will be randomised to balloon-expandable TAVI either with or without routine 'double tap' balloon post-dilation.

Radial Versus Femoral Secondary Access in Patients Undergoing TAVI

Severe symptomatic aortic stenosis (AS) with a high gradient is associated with a poor prognosis if not treated with valve replacement. Transcatheter aortic valve implantation has been shown in large randomized trials to be a safe and effective treatment option for patients at low, intermediate, or high risk. Transfemoral access for heart valve replacement is by far the most commonly used approach, as it is relatively easy to control and has a low complication rate compared to other access routes. The TAVI procedure requires two arterial access points: one with a large lumen for the TAVI prosthesis via the femoral artery, and a smaller second one for a pigtail catheter that guides the TAVI prosthesis into the optimal position. This secondary access is most often via a second artery. Vascular complications are the most commonly observed complications in transfemoral TAVI and are associated with poorer procedural outcomes. Recent data suggest that secondary vascular access via the radial artery may contribute to a reduction in vascular complications after TAVI. In patients undergoing coronary angiography and/or percutaneous coronary intervention, radial access has become the preferred strategy due to its proven reduction in vascular complications compared to femoral access. The use of radial access is associated with a lower incidence of vascular complications compared to femoral access. Recent non-randomized data suggest that radial access may be a safer alternative to traditional femoral access as a secondary arterial access in transfemoral TAVI. However, non-randomized retrospective comparisons are subject to selection bias and underreporting of complications. Therefore, a prospective randomized trial is needed to evaluate the value of radial access for secondary arterial access in patients undergoing transfemoral TAVI.

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 aortic stenosis (AS) and iron deficiency (ID), undergoing transcatheter aortic valve implantation (TAVI). The main questions it aims to answer are: 1. Does intravenous iron therapy improve HRQOL after TAVI in patients with severe AS and ID compared to no intravenous iron therapy (standard of care)? 2. Can intravenous iron therapy enhance exercise capacity, as measured by the 6-minute walk test, after TAVI in patients with severe AS and ID compared to no intravenous iron therapy (standard of care)? The intervention group (receiving iron therapy after TAVI) will be compared to the control group (receiving no iron therapy after TAVI (standard of care)). Participants will: * Provide written informed consent * Be randomly assigned to one of two groups: 1. Intervention group: receiving intravenous iron therapy after TAVI (1-3 administrations in the course of 12 weeks) 2. Control group: receiving standard of care (= no iron therapy) * Complete assessments of HRQOL and the 6-minute walk test at baseline and week 24 after TAVI. * During follow-up visits, other clinical parameters will be collected (i.e. laboratory status, mortality status, adverse clinical events)

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 stenosis.

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. Moreover, the study will evaluate interpopulation differences in aortic root anatomy based on computed tomography analysis.

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. The improvement in haemodynamics following TAVI may positively influence gut microbial balance by increasing splanchnic perfusion and reducing intestinal congestion. A total of 40 patients undergoing TAVI at the "Hippokration" General Hospital of Athens will be enrolled, with the aim of analysing stool and blood samples before and after the procedure. The primary endpoint is the change in gut microbiota composition two months post-TAVI, assessed via 16S rRNA sequencing. Secondary endpoints include changes in serum TMAO levels and their association with the severity of aortic stenosis and post-procedural valve haemodynamics. Data will be collected at two timepoints (1 month up to 1 day pre-TAVI and 3 to 4 months post-TAVI), along with dietary questionnaires to account for potential confounding factors. This observational study aims to highlight the potential relationship between cardiac function and the gut microbiome, offering new perspectives for targeted therapeutic strategies in cardiovascular disease.

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. The goal of this observational prospective trial is to investigate the role of pre-procedural values of systemic biomarkers of inflammation and fibrosis in the prediction of new-onset CDs and permanent pacemaker implantation (PPI) in patients undergoing the TAVI procedure.

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. While the clinical outcomes of TAVI are well established, there is limited data on the long-term quality of life (QoL) following the procedure. This prospective study will assess QoL in patients undergoing TAVI at Derriford Hospital, University Hospitals Plymouth, UK. Investigators will employ the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and Mini-Montreal Cognitive Assessment (Mini-MoCA) to evaluate both physical and mental health outcomes, supplemented by an analysis of life expectancy estimated by a multidisciplinary team (MDT). Data will be collected at referral, pre-procedural, 30 days, and 3 months post-TAVI. This will be the first prospective trial focused on QoL improvement after TAVI, as all previous studies have been retrospective in nature. The study aims to provide comprehensive insights into the QoL improvements after TAVI, which will guide future clinical decision-making in this population.

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. The system integrates with standard procedural workflows and enables remote manipulation of delivery system components, allowing for controlled, stable, and reproducible movements. TAVIPILOT facilitates accurate valve alignment and deployment, reducing operator variability. The robot is compatible with approved balloon-expandable transcatheter heart valves (Sapien 3 and Ultra, Edwards Lifesciences, USA) and standard catheterization lab infrastructure.

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. It works alongside conventional fluoroscopy, using real-time image analysis to provide precise anatomical landmarks. TAVIPILOT Software detects key anatomical structures, tracks valve positioning, and uses AI-based confidence indicators to assist in alignment. The software is compatible with approved C-arm imaging systems and specific catheter models. The objective is to assess the feasibility and safety of the TAVIPILOT Software augmented reality guidance software during TAVI procedures, aiming to improve valve positioning precision and, implicitly and to reduce implantation depth variations.

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. It works alongside conventional fluoroscopy, using real-time image analysis to provide precise anatomical landmarks. TAVIPILOT Software detects key anatomical structures, tracks valve positioning, and uses AI-based confidence indicators to assist in alignment. The software is compatible with approved C-arm imaging systems and specific catheter models. The objective is to assess the feasibility and safety of the TAVIPILOT Software augmented reality guidance software during TAVI procedures, aiming to improve valve positioning precision and, implicitly and to reduce implantation depth variations.

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). The study uses a non-invasive monitoring system (NIRS) to track brain oxygenation (rSO₂) in real time. The goal is to understand whether balloon-expandable, intra-annular self-expanding, or supra-annular self-expanding valves lead to different levels or patterns of cerebral oxygenation. This may help identify early warning signs for delayed hemodynamic recovery, stroke, or delirium. Participants will be randomly assigned to receive one of: A balloon-expandable valve (Group A), or A self-expanding valve (Group B), with further randomization into: Group B1: intra-annular valve (NAVITOR) Group B2: supra-annular valve (EVOLUT) The procedure, follow-up, and data collection will follow standard clinical practice. No experimental devices or drugs are used. Patients will not undergo any additional risk or burden beyond what is normally expected during TAVI. The study is being conducted at the Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome, Italy, and aims to enroll 40 patients. No compensation is provided, and participation is voluntary.

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 assessment, ECG, and laboratory tests. * Post-implantation: echocardiography, laboratory tests, ECG, assessment of any procedural complications, and a cardiology follow-up visit. This is an observational study, with the aim to monitor over time the population of patients who have undergone TAVI, identifying pre- and post-implant conditions that may negatively impact patient outcomes (both clinical factors and those directly related to the prosthetic implant). Through a 10-year follow-up, the study seeks to determine the incidence of prosthetic failure, as well as the incidence of prosthesis-related complications and major clinical endpoints.

Optimization of Heart Failure (HF) Medical Therapy After Transcatheter Valve Intervention (TVI) in Patients With Heart Failure With Reduced Ejection Fraction (HFrEF)

This trial is a single-center, open-label, randomized study designed to assess the impact of a rapid up-titration of Guideline-Directed Medical Therapy (GDMT) on heart failure with reduced ejection fraction (HFrEF) patients following transcatheter valve interventions. The study focuses on the efficacy of intensive treatment in decreasing NT-proBNP levels and improving patient outcomes, including survival rates and quality of life over a six-month period. Patients are closely monitored using both Point-of-Care technology and hospital-based assessments, with the goal of enhancing GDMT adjustments. This approach is compared to standard care to determine its potential benefits in the management of HFrEF post-valve intervention.

Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial

Aspirin group: Aspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period. Non-antithrombotic group: No antithrombotic agents will be administered after randomization until the end of the study period.