Clinical trials: Transcatheter Aortic Valve Replacement (TAVR), open to volunteers
Atrial Fibrillation
Pharmacological Intervention to Prevent NOAF After TAVR
The goal of this clinical trial is to learn if amiodarone or metoprolol works to prevent new-onset atrial fibrillation (AF) in patients who develop certain atrial arrhythmias after transcatheter aortic valve replacement (TAVR).
- Trial name
- NCT07519161
- Testing
- Metoprolol succinate, Amiodarone
- Volunteers
- 198 people
- Sponsor
- Shanghai East Hospital
Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction
REVIVE-FR Registry
This registry aims to investigate treatment options for patients whose previously implanted biological aortic heart valve no longer functions properly.
- Conditions
- Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction, Structural Valve Deterioration, Prosthetic Heart Valve Thrombosis
- Trial name
- NCT07885761
- Testing
- TAVI-in-SAVR (Valve-in-Valve), THV-in-THV (Redo-TAVI), Surgical Explantation of a Failed Transcatheter Heart Valve
- Volunteers
- 200 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Left Ventricle Function, Transcatheter Aortic Valve Replacement (TAVR)
Phenotyping Left Ventricle Failure With Hemodynamic Biomarkers From 4D Flow Magnetic Resonance Imaging
This study aims to enhance and streamline intracardiac 4D Flow magnetic resonance imaging (MRI) processing by increasing automation for the quantitative and systematic assessment of left ventricular (LV) dysfunction.
- Conditions
- Left Ventricle Function, Transcatheter Aortic Valve Replacement (TAVR), Aortic Valve Stenosis
- Trial name
- TRANSLATE (NCT07455292)
- Testing
- Cardiac MRI with 4D Flow acquisition and invasive signal routinely collected during transcatheter aortic valve replacement
- Where
- 2 sites in Italy
- Volunteers
- 190 people
- Sponsor
- IRCCS Policlinico S. Donato
Aortic Stenosis, Severe, Aortic Stenosis
Same-Day Versus Standard Hospital Discharge After TAVI (HOME-TAVI)
Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe aortic stenosis across a broad range of surgical risk.
- Trial name
- HOME-TAVI (NCT07738575)
- Testing
- Same-Day Discharge Strategy, Standard-of-Care Discharge Strategy
- Where
- 3 sites in Canada, Spain
- Volunteers
- 764 people
- Sponsor
- Hospital Clinic of Barcelona
Aortic Valve Stenosis, Postoperative Complications
Comparing Suture vs. Combined Closure Strategies for Large Blood Vessel Access in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
The goal of this clinical trial is to compare two strategies for closing the main artery access site in adult patients undergoing transcatheter aortic valve implantation (TAVI) through a blood vessel in the leg (transfemoral…
- Conditions
- Aortic Valve Stenosis, Postoperative Complications, Vascular System Injuries, Hemorrhage
- Trial name
- SEAL-TAVI (NCT07743697)
- Testing
- Single Suture-Based Vascular Closure Device, Extravascular Collagen Plug-Based Closure Device
- Where
- Switzerland
- Volunteers
- 705 people
- Sponsor
- University Hospital, Basel, Switzerland
Aortic Valve Stenosis, Heart Failure
ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement
The goal of this trial is to to determine whether use of a novel SGLT2 inhibitor, Enavogliflozin 0.3 mg once daily is superior to placebo, when added to standard-of-care, in reducing the composite of major cardiovascular events…
- Trial name
- ENAVO-TAVR (NCT05672836)
- Testing
- Enavogliflozin, Standard-of-Care
- Where
- 31 sites in South Korea
- Volunteers
- 1,040 people
- Sponsor
- Duk-Woo Park, MD
TAVI(Transcatheter Aortic Valve Implantation)
SAIRO - Feasibility and Safety of the Tele-operated TAVIPILOT Robot Guided by TAVIPILOT Software
The TAVIPILOT robotic platform, developed by Caranx Medical is an advanced intraoperative robotic assistance system designed to enhance the precision of transcatheter aortic valve positioning during TAVR.
- Trial name
- SAIRO (NCT07664163)
- Testing
- TAVR procedure with TAVIPILOT Software and tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR.
- Where
- 2 sites in Australia
- Volunteers
- 10 people
- Sponsor
- Caranx Medical
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.
Aortic Stenosis
PRessure-based Evaluation of Disease Improvement in the Course of TAVI
The goal of this prospective observational study is to learn if advanced heart pressure wave analysis (using methods called WIA and REPA) can help predict the success of the procedure and long-term recovery in adults (aged 60-90)…
- Trial name
- PREDIC-TAVI (NCT07509554)
- Testing
- Transcatheter aortic valve replacement (TAVR / TAVI)
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Aortic Stenosis, Calcific, Aortic Valve Stenosis
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
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.
- Trial name
- PROGRESS (NCT04889872)
- Testing
- SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
- Where
- 80 sites in United States, Australia and 4 more
- Volunteers
- 2,250 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis Treated With TAVI, Aortic Diseases
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The objective of this pivotal study is to compare the safety and effectiveness of the F2 CPC (Treatment group) to a Control group (no embolic protection) in participants undergoing transfemoral (TF) TAVR with commercially…
- 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 VALVE DISEASES, Bicuspid Aortic Valve (BAV)
Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China
Safety, effectiveness and durability of Sapien 3 transcatheter aortic valve replacement in young aortic valve stenosis patients from China：A multi-center, retrospective and prospective, single arm, observational study
- Trial name
- NCT06830499
- Testing
- Transcatheter Aortic Valve Replacement (TAVR)
- Where
- 4 sites in China
- Volunteers
- 450 people
- Sponsor
- Xijing Hospital
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement (TAVR)
CHATEAU Registry: Clinical Outcomes After Transcatheter Aortic Valve Replacement
This study is a multicenter, retrospective registry study using the CHATEAU Registry. The study will evaluate patients who underwent transcatheter aortic valve replacement between January 2021 and December 2025.
- Trial name
- CHATEAU (NCT07709858)
- Testing
- Transcatheter Aortic Valve Replacement
- Where
- South Korea
- Volunteers
- 4,000 people
- Sponsor
- Eunpyeong St. Mary's Hospital
Severe Aortic Valve Stenosis
Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Reduce Thromboembolic and Bleeding Events in Non-atrial Fibrillation Patients After Transcatheter Aortic Valve Implantation
The POPular ATLANTIS trial aims to investigate CT-guided antithrombotic therapy compared to lifelong single antiplatelet therapy after a transcatheter aortic valve implantation (TAVI) procedure.
- Trial name
- POP ATLANTIS (NCT06168370)
- Testing
- CT guided strategy
- Where
- Netherlands
- Volunteers
- 2,500 people
- Sponsor
- St. Antonius Hospital
Aortic Valve Stenosis, Bicuspid Aortic Valve
Bicuspid Aortic Valve Replacement: Evaluation of Transcatheter Versus Surgery-Pilot Trial
The study protocol is a randomized trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV).
- Trial name
- BELIEVE-IT (NCT06817148)
- Testing
- transcatheter aortic valve replacement (TAVR), surgical aortic valve replacement (SAVR)
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Cedars-Sinai Medical Center
Severe Aortic Stenosis, Cardiogenic Shock
Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR
The goal of this clinical trial is to evaluate the feasibility, effectiveness, and safety of pre-emptive left atrial veno-arterial extracorporeal membrane oxygenation (LAVA-ECMO) in patients undergoing complex and high-risk…
- Conditions
- Severe Aortic Stenosis, Cardiogenic Shock, Cardiogenic Shock, ECMO, Trans-catheter Aortic Valve Implantation
- Trial name
- PROTECT-TAVR (NCT07309029)
- Testing
- Left Atrial Veno-Arterial Extracorporeal Membrane Oxygenation (LAVA-ECMO)
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Atlantic Health System
Aortic Valve Stenosis, Aortic Stenosis
CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material
The objective of this study is to demonstrate safety and efficacy of the EmStop Embolic Protection System when used as indicated to capture and remove thrombus/debris during self-expanding transcatheter aortic valve replacement…
- Conditions
- Aortic Valve Stenosis, Aortic Stenosis, Aortic Valve Disease
- Trial name
- NCT07276711
- Testing
- EmStop Embolic Protection System, Boston Scientific Sentinel
- Where
- 7 sites in United States
- Volunteers
- 663 people
- Sponsor
- EmStop Inc
Severe Aortic Valve Stenosis, Aortic Valve Stenosis
Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation
The optimal pharmacological therapy after transcatheter aortic valve implantation (TAVI) to prevent valve thrombosis and reduce thromboembolic complications without significantly increasing the risk of bleeding is not yet fully…
- Conditions
- Severe Aortic Valve Stenosis, Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Aortic Valve Implantation (TAVI)
- Trial name
- REAC-TAVI2 (NCT05283356)
- Testing
- Ticagrelor 60mg
- Where
- Spain
- Volunteers
- 1,206 people
- Sponsor
- Fundacin Biomedica Galicia Sur
Aortic Regurgitation, Transcatheter Aortic Valve Replacement
TAVR for Aortic Regurgitation Under TEE Guidance
Under contemporary practice, transcatheter aortic valve replacement (TAVR) is typically performed with fluoroscopic visualization and repeated injections of iodinated contrast.
- Trial name
- NCT07453849
- Testing
- TEE guided TAVR
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
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