Clinical trials: Transcatheter Valve Replacement
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow…
- Conditions
- Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease
- Trial name
- NCT03130777
- Testing
- Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
- Where
- 14 sites in United States
- Volunteers
- 86 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Rationale: Transcatheter aortic valve implantation (TAVI) has become the standard of care for aortic stenosis across all surgical risk categories, including low-risk, younger patients (≥70 years).
- Conditions
- Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening, Valve Expansion, Transcatheter Aortic Valve Replacement
- Trial name
- SYMMETRY (NCT07872020)
- Testing
- Double-TAP post-dilatation
- Where
- 5 sites in Germany, Netherlands
- Volunteers
- 422 people
- Sponsor
- Erasmus Medical Center
Aortic Valve Stenosis and Insufficiency, Coronary Artery Disease(CAD)
Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial
The goal of this clinical trial is to determine whether a non-invasive coronary assessment strategy using photon-counting detector computed tomography (PCD-CT) is non-inferior to invasive coronary angiography (ICA) for evaluating…
- Conditions
- Aortic Valve Stenosis and Insufficiency, Coronary Artery Disease(CAD), Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- TAVR-CT (NCT07107568)
- Testing
- Standard Invasive Coronary Angiography, PCD-CT-Guided Diagnostic Strategy
- Where
- 2 sites in Austria
- Volunteers
- 700 people
- Sponsor
- Medical University Innsbruck
Tricuspid Regurgitation (TR), Valvular Heart Diseases
Robotic Transjugular Transcatheter Tricuspid Valve Replacement
Valvular heart disease (VHD), caused by abnormalities in heart valves, can lead to severe complications such as heart failure and death, with approximately 220 million affected patients worldwide.
- Conditions
- Tricuspid Regurgitation (TR), Valvular Heart Diseases, Transcatheter Valve Replacement
- Trial name
- Robotic Lux (NCT07516145)
- Testing
- Transcatheter tricuspid valve replacement
- Where
- Hong Kong
- Volunteers
- 10 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
Mitral Regurgitation, Mitral Stenosis
Abbott Cephea Mitral Valve Disease Registry
The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease.
- Conditions
- Mitral Regurgitation, Mitral Stenosis, Mitral Valve Disease, Mitral Valve (MV) Regurgitation
- Trial name
- NCT07069673
- Where
- 24 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Transcatheter Aortic Valve Replacement (TAVR), Aortic-Stenosis
Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve
Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.
- Conditions
- Transcatheter Aortic Valve Replacement (TAVR), Aortic-Stenosis, Aortic Insufficiency, Degenerative Valve Disease
- Trial name
- RESOUND-EU (NCT06953206)
- Testing
- Transcatheter aortic valve (S3UR) replacement (TAVR)
- Where
- Germany
- Volunteers
- 500 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Transcatheter Aortic Valve Replacement (TAVR), Left Ventricular Hypertrophy
Angiotensin Receptor Blocker After TAVR in Severe Aortic Stenosis With Left Ventricular Hypertrophy (ARBITAR)
This is a multicenter, prospective, open-label, randomized, investigator-initiated trial evaluating whether angiotensin receptor blocker (ARB) therapy improves clinical outcomes in patients with severe aortic stenosis (AS) and…
- Conditions
- Transcatheter Aortic Valve Replacement (TAVR), Left Ventricular Hypertrophy, Severe Aortic Stenosis
- Trial name
- ARBITAR (NCT07735130)
- Testing
- Angiotensin Receptor Blocker (ARB)
- Where
- South Korea
- Volunteers
- 632 people
- Sponsor
- Seoul National University Hospital
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 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
Transcatheter Aortic Valve Replacement
CT TAVR Abdomen Study
A standard polyenergetic CT (computed tomography) procedure utilizes 100 ml of iodinated contrast. A recent world-wide shortage of iodine based intravenous contrast has highlighted the need to search for alternative methods or…
- Trial name
- CT TAVR (NCT05758701)
- Testing
- Iodinated Contrast Agent (Omnipaque), Dual Energy CT
- Where
- United States
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Transcatheter Aortic Valve Replacement
Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR
This study will compare the use of one Perclose device to the usual approach of two devices for pre-closure during Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT06871774
- Testing
- Single Perclose Pro vascular closure device, Dual Perclose vascular closure device
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Wake Forest University Health Sciences
Transcatheter Aortic Valve Replacement, Closure Technique
This Study Will Evaluate the Safety and Potential Complications of Dual ProGlide vs Single ProGlide and Angioseal for Common Femoral Arteriotomy Closure Following Transcatheter Aortic Valve Replacement
This prospective, randomized, parallel, single-center, open-label, non-inferiority study will evaluate the safety and potential complications of dual ProGlide vs single ProGlide and Angioseal for common femoral arteriotomy…
- Trial name
- TAVI-CLOSE (NCT06983938)
- Testing
- Double Perclose Proglide, Single Perclose Proglide plus Angioseal
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- Baylor Research Institute
Transcatheter Aortic Valve Replacement (TAVR), Cerebral Vascular Accident (CVA)/Stroke
Evaluation of the Safety and Effectiveness of CHORDS® Cerebral Protection System During TAVR: DUET Trial
This is a prospective, multi-center, randomized controlled study. The goal of the study is to assess the safety and effectiveness of the Resonova® CHORDS® Cerebral Protection System in capturing and removing embolic debris during…
- Trial name
- NCT07648693
- Testing
- CHORDS® Cerebral Protection System, Sentinel Cerebral Protection System
- Where
- 15 sites in China
- Volunteers
- 240 people
- Sponsor
- Resonova (Shanghai) Medtech Limited
Mitral Insufficiency, Transcatheter Aortic Valve Replacement
Transcatheter Mitral and Tricuspid Interventions: a Cardiac Magnetic Resonance Study
Mitral and tricuspid valve disease represents an increasing challenge in the management of patients with heart failure and other cardiovascular diseases.
- Trial name
- TEMATIC-MR (NCT07370467)
- Where
- Italy
- Volunteers
- 250 people
- Sponsor
- Centro Cardiologico Monzino
Transcatheter Aortic Valve Replacement, Atrial Fibrillation New Onset
Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement
Transcatheter aortic valve implantation (TAVI) is a well-established alternative to surgical aortic valve replacement for the treatment of patients with symptomatic severe aortic stenosis.
- Conditions
- Transcatheter Aortic Valve Replacement, Atrial Fibrillation New Onset, Pacemaker, Colchicine
- Trial name
- Co-STAR (NCT04870424)
- Testing
- Colchicine
- Where
- Switzerland
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Conduction Disturbances, Transcatheter Aortic Valve Replacement
Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR
The high incidence and variety of conduction disturbances post-TAVR represents a major challenge in the periprocedural management of TAVR recipients.
- Conditions
- Conduction Disturbances, Transcatheter Aortic Valve Replacement, Permanent Pacemaker Implantation
- Trial name
- PROMOTE (NCT04139616)
- Where
- Canada
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Transcatheter Aortic Valve Replacement, Coronary Artery Disease
Coronary Artery Disease Assessment Strategies in TAVI Patients
Coronary artery disease (CAD) and aortic stenosis frequently coincide. Before valve intervention, invasive coronary angiography is routinely performed to assess coronary status.
- Conditions
- Transcatheter Aortic Valve Replacement, Coronary Artery Disease, Heart Disease Risk Factors
- Trial name
- CAT (NCT06559332)
- Testing
- Risk-based CAD management, Invasive coronary angiography
- Where
- Switzerland
- Volunteers
- 546 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Transcatheter Aortic Valve Replacement (TAVR), Aortic Valve Stenosis
Patient Quality of Recovery After TAVR With Different Sedation Regimens
The goal of this clinical trial is to learn whether the type of sedation medication used during a transcatheter aortic valve replacement (TAVR) affects how people recover after the procedure.
- Trial name
- NCT07556523
- Testing
- Propofol, Dexmedetomidine, Midazolam
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- David Lyubashevsky
Transcatheter Aortic Valve Replacement (TAVR)
EasyCrossTM Device-Self-centering Catheter
VIVHEART EasyCross™ is a self-centering device for inserting a guidewire through a heart valve. It consists in a temporary catheter inserted into an artery with a terminal part able to expand a distal structure with 6 arms…
- Trial name
- VIV-FIH (NCT06412354)
- Testing
- EasyCross™ first-in human
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Vivheart s.r.l.
High Degree Second Degree Atrioventricular Block, Complete Heart Block
RAFT-TAVR PACE: LBBAP vs. RVP Post-TAVR in Patients Requiring PPI
The RAFT-TAVR PACE study is a clinical trial designed to compare two types of heart pacing methods in patients who develop conduction problems after undergoing a transcatheter aortic valve replacement (TAVR) procedure.
- Conditions
- High Degree Second Degree Atrioventricular Block, Complete Heart Block, Heart Failure, Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- RAFT-TAVR PACE (NCT06857201)
- Testing
- Left Bundle Branch Area Pacing, Right Ventricular Pacing
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's