Clinical trials: Aortic Valve Replacement
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.
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
Aortic Valve Stenosis
REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System
The objective of the REPRISE EDGE study is to confirm the acute performance and safety of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set for transcatheter aortic valve implantation (TAVI) in…
- Trial name
- REPRISE EDGE (NCT02854319)
- Testing
- LOTUS Edge Valve System
- Where
- 3 sites in Denmark, France and 1 more
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
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 Valve Disorder, Aortic Valve Insufficiency
Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.
- Conditions
- Aortic Valve Disorder, Aortic Valve Insufficiency, Aortic Valve Stenosis, Heart Failure
- Trial name
- NCT01651052
- Testing
- Heart Valve Surgery
- Where
- 2 sites in Poland
- Volunteers
- 133 people
- Sponsor
- Edwards Lifesciences
Valve Heart Disease
Post-surgical Aortic Hemodynamics After Aortic Valve Replacement
The purpose of this pilot study is to obtain both near valve and downstream flow characteristics, using 3D transthoracic echocardiography and 4D flow MRI respectively, in an existing patient population at Northwestern Memorial…
- Trial name
- NCT03347851
- Testing
- MRI, Transthoracic echocardiography exam
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- CryoLife, Inc.
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
Aortic Stenosis, Severe
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
- Trial name
- NCT05172960
- Testing
- SAPIEN X4 THV, SAPIEN X4S
- Where
- 65 sites in United States, Australia and 2 more
- Volunteers
- 1,234 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Disease, Aortic Valve Stenosis
VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）
This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.
- Trial name
- VITAL (NCT05977257)
- Testing
- VitaFlow® Transcatheter Aortic Valve Replacement System
- Where
- 4 sites in China
- Volunteers
- 89 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Severe Symptomatic Aortic Stenosis
Assessment of St Jude Medical Portico Re-sheathable Transapical Aortic Valve System
The purpose of this study is to assess the safety and performance of the 23mm Portico Transcatheter Heart Valve and the TAVI Transapical Delivery System in subjects with severe symptomatic aortic stenosis
- Trial name
- Portico TA EU (NCT01742598)
- Testing
- Portico Transapical Aortic Valve System
- Where
- United Kingdom
- Sponsor
- Abbott Medical Devices
Aortic Valve Disease
Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve
The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve…
- Trial name
- CENTERA-1 (NCT01808274)
- Testing
- Edwards CENTERA Self-Expanding Transcatheter Heart Valve
- Where
- 4 sites in Germany, Switzerland
- Volunteers
- 34 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
TAVI(Transcatheter Aortic Valve Implantation)
Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI) in Australia
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 (NCT07121907)
- Testing
- TAVR using a guidance software
- Volunteers
- 10 people
- Sponsor
- Caranx Medical
Aortic Valve Disease
Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna
The purpose of this study is to compare sizing,implant techniques, and hemodynamics between the Mitroflow Pericardial Aortic Valve and the Edwards Magna Heart Valve.
- Trial name
- NCT00705913
- Testing
- Mitroflow Aortic Pericardial Heart Valve (CarboMedics), Carpentier-Edwards Magna Tissue Valve
- Where
- 12 sites in United States, Canada
- Volunteers
- 368 people
- Sponsor
- Sorin Group USA, Inc.
Aortic Valve Replacement
INSPIRIS China PMCF Study
The objective of this post-market trial is to evaluate long term safety and performance of the Edwards Lifesciences INSPIRIS RESILIA aortic valve in Chinese patients in a real-world clinical setting.
- Trial name
- INSPIRIS China (NCT05404880)
- Testing
- EDWARDS INSPIRIS RESILIA Aortic Valve
- Where
- 12 sites in China
- Volunteers
- 255 people
- Sponsor
- Edwards Lifesciences
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 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