Clinical trials: Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement
REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System
The purpose of this study is to evaluate the safety and performance of the Lotus™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high…
- Trial name
- NCT01627691
- Testing
- Lotus Valve System
- Where
- 20 sites in Australia, France and 7 more
- Volunteers
- 250 people
- Sponsor
- Boston Scientific Corporation
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 Senile, Aortic Stenosis Symptomatic
Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis
The objective of this pivotal, prospective, multicenter, single-arm clinical trial is to evaluate the safety and clinical performance of the Next-Generation INOVARE® SAFESYNC Bioprosthetic Heart Valve, implanted via a…
- Conditions
- Aortic Stenosis Senile, Aortic Stenosis Symptomatic, Aortic Stenosis
- Trial name
- SAFESYNC NG (NCT07806409)
- Testing
- INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve
- Volunteers
- 40 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
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
NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population
The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome.
- Trial name
- FOLLOW (NCT03613246)
- Where
- 14 sites in Finland, Germany and 4 more
- Volunteers
- 346 people
- Sponsor
- NVT GmbH
Transcatheter Aortic Valve Replacement
The CAPTIS® Study - Embolic Protection in TAVR
This is a First in Human study with the Filerlex CAPTIS device designed to demonstrate the safety and feasibility of the device in subjects undergoing Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- NCT04659538
- Testing
- CAPTIS Embolic Protection device
- Where
- 3 sites in Israel
- Volunteers
- 20 people
- Sponsor
- Filterlex Medical Ltd.
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
Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction
This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Heart Defects, Congenital, Congenital Abnormalities
- Trial name
- NCT02987387
- Testing
- SAPIEN XT THV
- Where
- 12 sites in United States
- Volunteers
- 57 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Regurgitation, Aortic Valve Disease Mixed
JOURNEY LVAD: JOURNEY Left Ventricular Assist Device
The objective of this study is to assess the safety and effectiveness of the J-Valve Transfemoral Transcatheter Heart Valve System in patients on left ventricular assist device (LVAD) support with significant native aortic valve…
- Conditions
- Aortic Valve Regurgitation, Aortic Valve Disease Mixed, Aortic Insufficiency
- Trial name
- NCT07363473
- Testing
- J-Valve Transfemoral System
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Symptomatic Aortic Stenosis
The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation
The Keystone Heart TriGuard™ HDH is an aortic embolism deflection device intended to reduce the amount of embolic material that may enter the carotid, subclavian, and vertebral arteries during transcatheter heart valve…
- Trial name
- NCT02536196
- Testing
- Embolic Protection Device, Transcatheter aortic valve implantation (TAVI)
- Where
- 30 sites in United States, Germany and 2 more
- Volunteers
- 478 people
- Sponsor
- Keystone Heart
Anesthesia, General
Efficacy and Safety of Ciprofol Compared to Propofol for Nonintubated General Anesthesia in Patients Undergoing TAVR
The purpose of this study is to explore the efficacy and safety of ciprofol compared to propofol for non-intubated general anesthesia in patients undergoing transcatheter aortic valve replacement (TAVR).
- Trial name
- NCT05035069
- Testing
- Ciprofol, Propofol
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Transapical Transcatheter Aortic Valve Implantation
Safety and Efficacy Study of the Cardiapex Percutaneous Trans-apical Access and Closure System
A prospective, multicenter, uncontrolled study to evaluate the safety and efficacy of the Cardiapex percutaneous trans-apical access and closure system.
- Trial name
- NCT01722591
- Testing
- Cardiapex device
- Where
- 2 sites in Germany
- Volunteers
- 38 people
- Sponsor
- Cardiapex Ltd.
Aortic Stenosis
Post-Market Clinical Follow Up Study With Navitor Valve
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
- Trial name
- VISTA Nova (NCT06008080)
- Testing
- Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System
- Where
- 50 sites in Australia, France and 9 more
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Symptomatic Severe Aortic Stenosis
Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients
The study objective is to demonstrate that the clinical outcomes of the Myval balloon-expandable THV series are non-inferior to those of SAVR in patients with symptomatic severe aortic stenosis aged 65 to 75 years.
- Trial name
- START YOUNG (NCT06861361)
- Testing
- Myval balloon-expandable THV Series, Surgical bioprosthetic valve
- Where
- 49 sites in Austria, Estonia and 12 more
- Volunteers
- 1,180 people
- Sponsor
- Ceric Sàrl
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 Stenosis
DEFLECT I: Keystone Heart Embolic Deflection Trial
This is a research study using the Keystone Heart Embolic Deflection Device and involving patients with aortic stenosis (a disease of the aortic valve), to be treated with Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT01448421
- Testing
- Keystone Heart Embolic Deflection Device
- Volunteers
- 37 people
- Sponsor
- Keystone Heart
Aortic Stenosis Symptomatic
Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis
A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medical
- Trial name
- NCT06721676
- Testing
- transcatheter aortic valve replacement in severe aortic stenosis
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Aortic Valve Stenosis
Controlled Arterial Protection to Ultimately Remove Embolic Material
The objective of this study is to demonstrate device feasibility, safety and investigate performance of the EmStop Embolic Protection System when used as indicated in 15 subjects at 2 investigational sites in the U.S.
- Trial name
- CAPTURE-1 (NCT06103591)
- Testing
- The EmStop Embolic Protection System (EmStop System)
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- EmStop Inc
Aortic Stenosis
OpSens PRIME CLASS
In this study it is aimed to determine the diagnostic value of physiological measurements in the presence of aortic stenosis, and whether these are more accurate than angiographic assessment.
- Trial name
- NCT05070130
- Testing
- dPR and FFR
- Where
- 5 sites in Spain
- Volunteers
- 32 people
- Sponsor
- Opsens, Inc.
Aortic Valve Stenosis
Engager Direct Aortic Clinical Study
To confirm the safety and performance of the Medtronic Engager™ Transcatheter Aortic Valve Implantation System via direct aortic approach.
- Trial name
- NCT01789567
- Testing
- Engager™ aortic valve
- Where
- 6 sites in Czechia, Germany and 1 more
- Volunteers
- 20 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure