Clinical trials: Aortic Valve Replacement
Bicuspid Aortic Valve
Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
- Trial name
- NCT03635424
- Testing
- Medtronic TAVR Systems
- Where
- 25 sites in United States
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiovascular
Aortic Stenosis
REPRISE Next Generation Delivery System
To confirm the acute performance and safety of the Lotus™ Valve with the Next Generation Delivery System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are…
- Trial name
- NGDS (NCT02329496)
- Testing
- Lotus Valve and LOTUS Edge Valve System
- Where
- 2 sites in Australia
- Volunteers
- 38 people
- Sponsor
- Boston Scientific Corporation
Aortic Regurgitation
HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation
To evaluate the safety and performance of The Meridian® TAVR Valve in patients with severe aortic regurgitation who present at high risk for aortic valve replacement surgery.
- Trial name
- RIVAL - AR EFS (NCT05409378)
- Testing
- The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System)
- Where
- 3 sites in United States
- Sponsor
- HLT Inc.
Stroke, Aortic Valve Stenosis
Acute STROke Complicating TAVI - Management and Outcomes
Periprocedural complications of trans catheter aortic valve implantation, and particularly the occurrence of stroke has a marked impact on survival and quality of life.
- Conditions
- Stroke, Aortic Valve Stenosis, Periprocedural Complication
- Trial name
- ASTRO-TAVI (NCT05241821)
- Testing
- Mechanical thrombectomy, Thrombolytic Agent
- Where
- Israel
- Volunteers
- 484 people
- Sponsor
- Rabin Medical Center
Aortic Stenosis
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement (REPRISE Japan)
The objective of this study is to confirm the safety and effectiveness of the Lotus™ Valve System in the Japanese medical environment for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe…
- Trial name
- NCT02491255
- Testing
- Lotus Valve System
- Where
- 5 sites in Japan
- Volunteers
- 70 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Stenosis
ASAN Medical Center Aortic Valve Replacement Registry
This study evaluates the effectiveness and safety of surgical aortic valve replacement and transcatheter aortic valve replacement in aortic Stenosis.
- Trial name
- ASAN-AVR (NCT03298178)
- Testing
- TAVR, SAVR
- Where
- South Korea
- Volunteers
- 900 people
- Sponsor
- Ho-Jin Kim
Aortic Valve Stenosis, Aortic Valve Replacement
Effects of Aortic Valve Replacement on Myocardial T1 Values in Severe Aortic Valve Stenosis
Background: Severe aortic valve stenosis (AS) is the commonest valve disease. Aortic valve replacement (AVR) is primarily indicated when symptoms occur and/or when there is a drop in left ventricular ejection fraction.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Replacement, Myocardial Fibrosis, Cardiac Magnetic Resonance
- Trial name
- FIBROTIC (NCT05404100)
- Testing
- Aortic valve replacement
- Where
- Denmark
- Volunteers
- 86 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Coronary Artery Bypass Graft Surgery, Aortic Valve Replacement
Outcomes After Albumin Vs Lactated Ringer's Solution in CABG and AVR Procedures
This is a prospective, randomized, double-blinded study to compare the use of albumin versus lactated Ringer's solution in patients undergoing coronary artery bypass graft surgery and in patients undergoing aortic valve…
- Trial name
- NCT04652375
- Testing
- Albumin Solution, Lactated Ringer's Solution
- Where
- United States
- Volunteers
- 131 people
- Sponsor
- Yale University
Postoperative Atrial Fibrillation
Post-Operative Atrial Fibrillation After Surgical Aortic Valve Replacement and the Influence of Statins
Statins have rapid and significant actions that have potentially important (but not yet proven) implications for postoperative atrial fibrillation and cardiac protection in patients undergoing cardiac surgery.
- Trial name
- NCT05062239
- Testing
- Discontinuance of treatment with statins 7 to 14 days prior to surgery until 30 days postoperative, No-intervention.
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- Lars Peter Riber
Aortic Valve Disease, Aortic Valve Stenosis
Evaluation of the Inflammatory Response in Post-operated Aortic Valve Replacement Patients.
Background Calcification of the aortic valve affects more than 26% of adult patients over 65 years of age and is the main indication for valve replacement in the United States of America.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification, Prosthetic Valve Malfunction
- Trial name
- NCT04557345
- Testing
- Determination of cytokines, Two-dimensional transthoracic echocardiogram
- Where
- Mexico
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
Aortic Stenosis
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve Replacement System With Retrievable Delivery Catheter System
The TaurusOne® transcatheter aortic valve system with retrievable delivery catheter system is evaluated the safety and effectiveness for the delivery of artificial aortic valve in a prospective, multicenter, single-arm clinical…
- Trial name
- NCT04744857
- Testing
- The experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system.
- Where
- China
- Volunteers
- 85 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Aortic Stenosis
The Role of Myocardial Fibrosis in Patients With Aortic Stenosis
Aortic stenosis is the most common adult valvular heart disease in the western world. Heart failure and sudden cardiac death are complications associated with aortic stenosis.
- Trial name
- NCT01755936
- Testing
- Cardiac Magnetic Resonance Imaging, Echocardiography, 72 hour Holter Monitor
- Where
- United Kingdom
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- University of Edinburgh
Aortic Valve Stenosis, Extracorporeal Circulation
Cerebral Embolic Load in Patients Undergoing Surgical Aortic Valve Replacement: A Comparison of the Conventional With the Minimized Extracorporeal Circulation Technique Using Transcranial Doppler Ultrasound
In this study, the investigators aim to compare cerebral embolic load in patients undergoing surgical aortic valve replacement using either the minimized extracorporeal circulation or the conventional extracorporeal circulation…
- Trial name
- AKE-MECC (NCT02308566)
- Testing
- Minimized Extracorporeal Circulation (MECC), Conventional Extracorporeal Circulation (CECC)
- Where
- Switzerland
- Volunteers
- 48 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Aortic Valve Stenosis
REPRISE EDGE 29 mm EU Study
The objective of the REPRISE EDGE 29 mm EU study is to evaluate performance and safety of the 29 mm LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native…
- Trial name
- NCT02964962
- Testing
- 29 mm LOTUS Edge™ Valve System
- Sponsor
- Boston Scientific Corporation
Transcatheter Aortic Valve Replacement
Ultrasound-guided Femoral Puncture to Reduce Access- Related Complications After TAVR: (ACCESS-TAVR SIRIO)
Recent observational data showed a marked reduction of vascular and bleeding complications by the use of ultrasound(US)-guided femoral artery puncture to gain the vascular access and guide the implantation of the Perclose…
- Trial name
- NCT05637983
- Testing
- US-guided femoral puncture vs Fluoroscopy-guided puncture
- Where
- Italy
- Volunteers
- 508 people
- Sponsor
- Fondazione Toscana Gabriele Monasterio
Aortic Valve Replacement in Patients With Moderate Aortic Stenosis Combined With Mitral Regurgitation
Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis and Mitral Regurgitation
The aim of the present study is to investigate safety and efficacy of early versus deferred aortic valve replacement in patients with moderate aortic stenosis combined with moderate mitral regurgitation.
- Trial name
- TIAMAR (NCT05310461)
- Testing
- Transcatheter or surgical aortic valve replacement with or without transcatheter or surgical mitral valve repair/replacement, Deferred treatment, with intervention once AVA is ≤1.0 cm2 or if concomitant mitral regurgitation meets an indication for intervention
- Where
- 3 sites in Switzerland
- Volunteers
- 80 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Aortic Valve Stenosis
Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement
Multicenter, prospective, observational study in aortic stenosis (AS) patients undergoing transcatheter aortic valve implantation (TAVI) or high-risk patients undergoing aortic valve replacement (AVR).
- Trial name
- CCQ (NCT01852552)
- Testing
- transcatheter aortic valve implantation, Aortic Valve Replacement
- Where
- Italy
- Volunteers
- 518 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Aortic Valve Regurgitation
Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation
The purpose of this multicenter, prospective and observational registry is to evaluate the safety and efficacy of TAVR for treatment of pure severe aortic valve regurgitation.
- Trial name
- NCT06381271
- Testing
- Transcatheter aortic valve replacement
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Xijing Hospital
Aortic Valve Disease
PAR I - Patient-to-Annulus Relation I
The Prosthesis-to-Annulus Relation I (PAR I) trial is a German multicenter study assessing the relation between the prosthetic GOA and the area of LVOT as potentially new parameter for the prediction of hemodynamic outcome.
- Trial name
- PARI (NCT02981004)
- Where
- 7 sites in Germany
- Volunteers
- 304 people
- Sponsor
- Abbott Medical Devices
Bicuspid Aortic Valve Disease
TAVR vs SAVR in Severe Bicuspid Aortic Stenosis
The study is a multicenter, randomized superiority trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV).
- Trial name
- BELIEVERS (NCT07413965)
- Testing
- Transcatheter Aortic Valve Replacement, the open chest surgery to replace the aortic valve
- Where
- United States
- Volunteers
- 1,200 people
- Sponsor
- Cedars-Sinai Medical Center