Clinical trials: Transcatheter Aortic Valve Replacement
Aortic Stenosis
The PROTEMBO SF Trial
The PROTEMBO SF Trial is a prospective, observational, multi-center, intention-to-treat study of the safety and feasibility of the ProtEmbo Cerebral Protection System in subjects with severe symptomatic native aortic valve…
- Trial name
- NCT03325283
- Testing
- ProtEmbo Cerebral Protection System
- Where
- 2 sites in Ireland, Latvia
- Volunteers
- 5 people
- Sponsor
- Protembis GmbH
Aortic Valve Disease
Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study
The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic…
- Trial name
- SAPIEN3 (NCT01808287)
- Testing
- Edwards SAPIEN 3 Transcatheter Heart Valve
- Where
- 17 sites in Canada, France and 3 more
- Volunteers
- 250 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
PrizValve® Transcatheter Aortic Valve Replacement Study
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not…
- Trial name
- NCT04836897
- Testing
- PrizValve® valve and transapical delivery system
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Symptomatic Aortic Stenosis
Portico TAVI Implant With Transfemoral Delivery System
The purpose of this study is to assess the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).
- Trial name
- NCT01493284
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- 14 sites in Australia, Denmark and 3 more
- Volunteers
- 222 people
- Sponsor
- Abbott Medical Devices
Bioprosthesis Failure
Renato® Transcatheter Valve-in-Valve System Multicenter Registry Trial (China)
The Renato® transcatheter valve-in-valve system, developed by Balance Medical, is undergoing a multicenter registry trial across China.
- Trial name
- VIV (NCT07174531)
- Testing
- Transcatheter valve in Valve implantation
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Beijing Balance Medical Technology Co., Ltd
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
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
Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic aortic stenosis undergoing a Transcatheter Aortic Valve replacement…
- Trial name
- NCT05893082
- Testing
- F2 Filter and Delivery System
- Where
- Australia
- Volunteers
- 18 people
- Sponsor
- EnCompass Technologies, Inc.
Aortic Stenosis
Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic aortic stenosis underdoing a Transcatheter Aortic Valve replacement…
- Trial name
- NCT05866640
- Testing
- F2 filter and delivery system
- Where
- Georgia
- Volunteers
- 31 people
- Sponsor
- EnCompass Technologies, Inc.
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
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.
Symptomatic Aortic Stenosis
The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) Post Marketing Surveillance (PMS) (CoreValve India PMS)
The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) has been demonstrated to be safe and effective for high through extreme risk patients with symptomatic severe native aortic stenosis or a stenosed…
- Trial name
- CoreValveIndia (NCT02759237)
- Testing
- CoreValve System Family
- Where
- India
- Volunteers
- 3 people
- Sponsor
- Medtronic Cardiovascular
TAVI(Transcatheter Aortic Valve Implantation)
Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI)
The TAVIPILOT Software by Caranx Medical is an advanced intraoperative assistance tool designed to enhance the accuracy of transcatheter aortic valve positioning during TAVI.
- Trial name
- SAITO 1B (NCT07100340)
- Testing
- TAVR using a guidance software
- Volunteers
- 10 people
- Sponsor
- Caranx Medical
Aortic Valve Stenosis
Engager Align Post-market Clinical Study
Purpose To characterize the safety and clinical benefit of the Engager Transcatheter Aortic Valve Implantation System in a real world environment.
- Trial name
- NCT02149654
- Testing
- Engager Transcatheter Aortic Valve Implantation System
- Where
- Netherlands
- Volunteers
- 27 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Stenosis
PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry
The purpose of this post-market registry is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™ Transferral Delivery System, when used as per IFU.
- Trial name
- PROGRESS (NCT02987894)
- Testing
- ACURATE neo™ Aortic Bioprosthesis
- Where
- 23 sites in Canada, Germany and 2 more
- Volunteers
- 500 people
- Sponsor
- Symetis SA
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
DurAVR™ THV System: EMBARK Study
A prospective, non-randomized, single-arm, single-center, first-in-human study designed to evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe aortic stenosis.
- Conditions
- Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification
- Trial name
- NCT05182307
- Testing
- DurAVR™ THV System
- Where
- Georgia
- Volunteers
- 150 people
- Sponsor
- Anteris Technologies Ltd.
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
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, 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, Symptomatic Aortic Stenosis
China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population
To evaluate the safety and effectiveness of the SAPIEN XT (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are…
- Conditions
- Aortic Stenosis, Symptomatic Aortic Stenosis, Aortic Regurgitation
- Trial name
- NCT03314857
- Testing
- SAPIEN XT THV with the NovaFlex+ delivery system
- Where
- 3 sites in China
- Volunteers
- 67 people
- Sponsor
- Edwards Lifesciences