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Last Updated: 10/31/2025
The Utilization of Single Versus Double Perclose Devices for Transfemoral Aortic Valve Replacement Access Site Closure: A Prospective, Multicenter, Randomized Controlled Trial
Summary: Transcatheter aortic valve replacement (TAVR) has become widely recognized as a minimally invasive approach for aortic valve replacement in patients with severe aortic stenosis. It has been proven to be a safe and effective option for patients who are at low, intermediate, and prohibitive risk for surgical valve replacement. One of the critical components of procedural success in a transfemoral ap...
The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement
Summary: This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation?
Summary: Transcatheter aortic valve implantation (TAVI) is a well-known safe and effective treatment for anatomically suitable patients with severe aortic stenosis (AS). Despite rapid improvements in TAVI technique and technology, vascular and bleeding complications from both primary and secondary access sites remain significant, with approximately 25% of access related complications thought to be related ...
A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Transcatheter Heart Valve System Versus Surgical Valve Replacement in Patients With Aortic Regurgitation
Summary: To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System compared with surgical aortic valve replacement (SAVR) for treatment of subjects with clinically significant native aortic regurgitation (AR)
The Role of Inflammation and Fibrosis in the Development of Conduction Disorders After Transcatheter Aortic Valve Implantation
Summary: 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...
Transcatheter Aortic Valve Replacement For Patients With Bicuspid Aortic Stenosis (Type 0) Using Down Sizing Strategy Compared With Standard Sizing Strategy (HANGZHOU Solution): A Prospective, Multicenter, Randomized Controlled Trial
Summary: To compare down sizing strategy versus annular sizing strategy technique (control group) in Type 0 bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs): a randomized superiority trial
Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure
Summary: The primary purpose of this study is to observe reduced access site complications in patients with heavily calcified common femoral arteries requiring Transcatheter Aortic Valve Replacement (TAVR)
Clinical Trial of the Results of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
Summary: The VIVALL-2 study is a randomized trial to compare the self-expandable supra-annular Allegra and the balloon-expandable intra-annular Edwards transcatheter valve systems in patients with degenerated biological aortic surgical valve.
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
Summary: The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).
First in Human Study of the GEMINUS Transcatheter Aortic Valve Implantation System in Patients With Severe Symptomatic Aortic Stenosis
Summary: The main objective of this study is to evaluate the feasibility and safety of the GEMINUS system in patients with severe symptomatic aortic stenosis. This is a prospective, open label, multicentre, single arm, first in human clinical study. Clinical follow up for all patients will be performed at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-implantation
Comparative Evaluation of LACI and LV Speckle Tracking for Pre- and Post-TAVI Patient Assessment: Advancing Outcome Precision in Aortic Valve Therapy
Summary: The aim of this study is to evaluate the combined utility of the left atrial coupling index (LACI) and left ventricular speckle tracking echocardiography (LVSTE) in improving risk stratification and outcome prediction for patients undergoing Transcatheter Aortic Valve Implantation (TAVI). This study seeks to identify novel prognostic markers that enhance the prediction of mortality, heart failure,...
Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation
Summary: Heparin reversal by protamine administration after transcatheter aortic valve implantation (TAVI) may reduce bleeding events. However, protamine can also cause life-threatening allergic reactions. High-quality evidence regarding the clinical safety and efficacy of routine protamine administration after TAVI is lacking. The aim of this clinical trial is to determine if routine protamine administrat...
Last Updated: 10/31/2025