Clinical trials: TAVI
Symptomatic Severe Aortic Stenosis
Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis
The purpose of this study is to evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.
- Trial name
- NCT07116551
- Testing
- Abbott BE TAVI System
- Where
- 5 sites in United States, France
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
Cerebral Embolicprotection Device, TAVR
Cerebral Embolic Protection Device During TAVR
To evaluate the safety and effectiveness of the Cerebral Protection System (model CEP016F, Shanghai Shenqi Medical Technology Co., Ltd.) for capturing and removing thrombotic and tissue debris during transcatheter aortic valve…
- Trial name
- NCT07627984
- Testing
- Cerebral embolic protection device
- Where
- China
- Volunteers
- 260 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
Symptomatic Aortic Stenosis
Optimize PRO Study
The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and…
- Trial name
- NCT04091048
- Testing
- Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)
- Where
- 60 sites in United States, Australia and 10 more
- Volunteers
- 1,127 people
- Sponsor
- Medtronic Cardiovascular
Aortic Stenosis Treated With TAVI
Zhicheng TAVR Robot
Use of the Transcatheter Aortic Valve Replacement Surgical Assist System and its Disposable Kit in Patients With Severe Aortic Stenosis to Evaluate the Safety and Efficacy of the Transcatheter Aortic Valve Replacement Surgical…
- Trial name
- NCT07392359
- Testing
- TAVR Assistance System, TAVR by manual
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Zhicheng Medical Technology (Jiaxing) Co, Ltd
Transcatheter Aortic Valve Replacement, Conduction Disturbance
Intra-procedural ECG Changes During TAVR
The purpose of this study is to evaluate electrocardiogram (ECG) changes in 100 patients undergoing transcatheter aortic valve replacement (TAVR) to assess new-onset conduction abnormalities, such as atrioventricular nodal block…
- Trial name
- NCT05791344
- Testing
- ECG monitoring
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Cara Medical Ltd
Aortic Stenosis
ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
- Trial name
- NCT03735667
- Testing
- ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System, Edwards SAPIEN 3 TAVR System
- Where
- 75 sites in United States, Canada
- Volunteers
- 1,948 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Stenosis
Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following TAVI Procedure
This study is designed to monitor the safety and performance of the V8 balloon when used as a postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI) device procedures.
- Trial name
- PostCorE (NCT02472106)
- Testing
- Post-dilatation
- Volunteers
- 9 people
- Sponsor
- InterValve, Inc.
Aortic Stenosis, Valvular Heart Disease
ADVANCE Direct Aortic Study
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve…
- Trial name
- NCT01676727
- Testing
- CoreValve aortic valve
- Where
- 9 sites in Czechia, France and 4 more
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Valve Stenosis, Heart Valve Diseases
RHEIA (Randomized researcH in womEn All Comers With Aortic Stenosis)
Purpose of this prospective, randomized, controlled, multi-center study is to evaluate the safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) as compared to surgical aortic valve replacement (SAVR) in female…
- Trial name
- RHEIA (NCT04160130)
- Testing
- Transcatheter aortic valve replacement
- Where
- 48 sites in Austria, Belgium and 10 more
- Volunteers
- 432 people
- Sponsor
- Optimapharm
Severe Symptomatic Calcified Native Aortic Valve Stenosis
Cerebral Protection in Transcatheter Aortic Valve Replacement
The Sentinel System will be a safe and effective method for capturing and removing embolic material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce the ischemic burden in the cerebral anterior…
- Trial name
- NCT02214277
- Testing
- Cerebral Protection System-The SENTINEL System with TAVR, TAVR
- Where
- 15 sites in United States, Germany
- Volunteers
- 363 people
- Sponsor
- Claret Medical
Severe Aortic Stenosis, Transcatheter Aortic Valve Replacemen
Alwide Plus China Post-market Clinical Investigation
This is a prospective, single-arm, multi-center, post-market registry study conducted in China. The purpose is to evaluate the safety and effectiveness of the AlwideTM Plus balloon catheter for pre-dilatation of the aortic valve…
- Trial name
- NCT07304427
- Where
- 4 sites in China
- Volunteers
- 75 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Aortic Diseases
INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis
This clinical investigation is being done to evaluate the safety and effectiveness of a new device, a PTV Balloon, that will be used to open up an area in the heart (the valve) before and potentially after placing a new valve in…
- Trial name
- NCT06816485
- Testing
- PTV (Percutaneous Transcatheter Valvuloplasty) Balloon
- Where
- 9 sites in Spain
- Volunteers
- 93 people
- Sponsor
- Biosensors Europe SA
Aortic Valve Stenosis, Heart Valve Diseases
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease, Heart Disease Structural Disorder
- Trial name
- ENVISION (NCT05932615)
- Testing
- Navitor Transcatheter Aortic Valve Implantation (TAVI) System, Any Commercially Available Transcatheter Aortic Valve (CAV) System
- Where
- 107 sites in United States, Australia and 11 more
- Volunteers
- 1,500 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis, Intracranial Embolism and Thrombosis
NAUTILUS CE-mark Trial of the FLOWer Cerebral Embolic Protection Device
The purpose of this clinical study is to assess the safety, performance, and treatment effect of the use of the AorticLab FLOWer System, in preventing cerebral thromboembolic complications in patients with indication for a TAVI…
- Trial name
- NAUTILUS (NCT04704258)
- Testing
- TAVI (Transcatheter Aortic Valve Implant), FLOWer Embolic Protection System
- Where
- 8 sites in Belgium, Italy
- Volunteers
- 100 people
- Sponsor
- AorticLab Srl
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 Valve Stenosis
Hydra Registry - UK
The study will evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) using the Hydra transcatheter aortic heart valve (THV) series, in patients with severe aortic stenosis up to 1-year after the…
- Trial name
- NCT06507579
- Testing
- Hydra transcatheter aortic valve (THV) series
- Where
- 4 sites in United Kingdom
- Volunteers
- 250 people
- Sponsor
- Sahajanand Medical Technologies Limited
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
Transcatheter Aortic Valve Implantation
Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis
The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System.
- Trial name
- EMPIRE (NCT05478161)
- Testing
- (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 11 sites in Germany, Netherlands and 1 more
- Volunteers
- 137 people
- Sponsor
- NVT GmbH
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, Valvular Cardiomyopathy
Feasibility of 3D Printed Models of Aortic Stenosis in Guiding TAVI Procedure
The aim of 3DP-FAST study is to analyze the accuracy of replicating cardiovascular anatomical structures using different techniques and to evaluate the feasibility of 3D printed models of aortic stenosis in guiding TAVI…
- Conditions
- Aortic Stenosis, Valvular Cardiomyopathy, Aortic Valve Disease
- Trial name
- 3DP-FAST (NCT05484713)
- Testing
- Cardiac imaging, 3D printing of the aortic valve
- Where
- Romania
- Volunteers
- 20 people
- Sponsor
- Cardio Med Medical Center