Clinical trials: Aortic Valve
Aortic Valve Insufficiency, Aortic Valve Stenosis
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.
- Trial name
- NCT05172973
- Testing
- SAPIEN X4/X4S THV
- Where
- 37 sites in United States, Canada
- Volunteers
- 200 people
- Sponsor
- Edwards Lifesciences
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
Aortic Valve Disease
Real World Data Collection on the INSPIRIS RESILIA Aortic Valve
Collect real-world data on hemodynamic and clinical outcomes of the INSPIRIS RESILIA Aortic Valve, Model 11500A, in subjects requiring replacement of their native or prosthetic aortic valve as the only heart valve procedure…
- Trial name
- INDICATE (NCT07120048)
- Testing
- Edwards INSPIRIS RESILIA Aortic Valve
- Where
- 15 sites in Germany
- Volunteers
- 500 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Disease
KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance
KONECTION is a prospective, observational, single-arm, multicenter study designed to collect real-world clinical outcomes in up to 250 participants who will receive the KONECT RESILIA aortic valved conduit, Model 11060A.
- Trial name
- KONECTION (NCT07619872)
- Testing
- Edwards KONECT RESILIA AVC
- Where
- 3 sites in Germany
- Volunteers
- 250 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
VitaFlow LIBERTY Europe
This is a prospective, single-arm, multi-center, observational, post-market clinical investigation to document the clinical safety and performance of MicroPort CardioFlow VitaFlow Liberty™ Transcatheter Aortic Valve System in the…
- Trial name
- NCT06535659
- Testing
- VitaFlow Liberty™ Transcatheter Aortic Valve System
- Where
- 9 sites in Ireland, Italy and 3 more
- Volunteers
- 222 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Moderate Aortic Valve Stenosis
Evolut™ EXPAND TAVR II Pivotal Trial
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
- Trial name
- NCT05149755
- Testing
- Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)
- Where
- 94 sites in United States, Australia and 14 more
- Volunteers
- 650 people
- Sponsor
- Medtronic Cardiovascular
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 Stenosis
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- RESTORE (NCT06777368)
- Testing
- Medtronic TAV, Edwards TAV
- Where
- 71 sites in United States
- Volunteers
- 225 people
- Sponsor
- Medtronic Cardiovascular
Aortic Stenosis
ECG-based AI Screening for Cases of Undiagnosed Moderate-to-Severe Aortic Stenosis in the Primary Care Setting
The goal of this observational study is to learn whether AccurKardia's AK-AVS algorithm can help identify moderate-to-severe aortic stenosis (AS), a narrowing of the heart's aortic valve, in older adults who have not yet been…
- Trial name
- NCT07827105
- Testing
- AK-AVS
- Where
- United States
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- AccurKardia, Inc.
Aortic Regurgitation, Aortic Valve Insufficiency
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System compared with surgical aortic valve replacement (SAVR) for treatment of subjects with clinically significant native aortic regurgitation (AR)
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency
- Trial name
- ARTIST (NCT06608823)
- Testing
- Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System, SAVR
- Where
- 34 sites in United States
- Volunteers
- 1,016 people
- Sponsor
- JenaValve Technology, 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
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
DurAVR™ THV EU-EFS
A prospective, non-randomized, single-arm, multi-center study designed to evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis or failed surgical…
- Conditions
- Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve Failure
- Trial name
- NCT06510855
- Testing
- DurAVR™ THV System
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
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
Heart Failure, Cardiomyopathies
Multimodal Physiologic State Intelligence Study
The OMNIPHYS study will investigate whether multimodal ultrasound and other routinely collected clinical and physiologic data can be combined with artificial intelligence to characterize changes in a person's physiologic state…
- Conditions
- Heart Failure, Cardiomyopathies, Pulmonary Hypertension, Myocarditis; Acute or Subacute
- Trial name
- OMNIPHYS (NCT07814118)
- Testing
- OMNIPHYS Multimodal Ultrasound Imaging System
- Where
- United States
- Volunteers
- 25,000 people, healthy volunteers welcome
- Sponsor
- Truway Health, Inc.
TAVI(Transcatheter Aortic Valve Implantation)
SAIRO - Feasibility and Safety of the Tele-operated TAVIPILOT Robot Guided by TAVIPILOT Software
The TAVIPILOT robotic platform, developed by Caranx Medical is an advanced intraoperative robotic assistance system designed to enhance the precision of transcatheter aortic valve positioning during TAVR.
- Trial name
- SAIRO (NCT07664163)
- Testing
- TAVR procedure with TAVIPILOT Software and tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR.
- Where
- 2 sites in Australia
- Volunteers
- 10 people
- Sponsor
- Caranx Medical
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 Valve Stenosis, Aortic Stenosis
CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material
The objective of this study is to demonstrate safety and efficacy of the EmStop Embolic Protection System when used as indicated to capture and remove thrombus/debris during self-expanding transcatheter aortic valve replacement…
- Conditions
- Aortic Valve Stenosis, Aortic Stenosis, Aortic Valve Disease
- Trial name
- NCT07276711
- Testing
- EmStop Embolic Protection System, Boston Scientific Sentinel
- Where
- 7 sites in United States
- Volunteers
- 663 people
- Sponsor
- EmStop Inc
Aortic Valve Stenosis, Aortic Valve Regurgitation
TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease
To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).
- Conditions
- Aortic Valve Stenosis, Aortic Valve Regurgitation, Aortic Valve Stenosis With Insufficiency, Constriction, Pathologic
- Trial name
- TAVIS (NCT05536310)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 3 sites in Germany
- Volunteers
- 24 people
- Sponsor
- JenaValve Technology, Inc.
Aortic Valve Stenosis
FIH Study of the GEMINUS TAVI System in Patients With Severe Symptomatic Aortic Stenosis
The main objective of this study is to evaluate the feasibility and safety of the GEMINUS system in patients with severe symptomatic aortic stenosis.
- Trial name
- NCT05909748
- Testing
- GEMINUS Transcatheter Aortic Valve Implantation system
- Where
- 2 sites in Israel
- Volunteers
- 30 people
- Sponsor
- Valve Medical
Calcific Aortic Valve Disease
A Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease With Mild to Moderate Aortic Stenosis (EVOID-AS)
This is an adaptive Phase 2/3 multicenter, double-blind, placebo-controlled, randomized, parallel, 2 arm study to evaluate the efficacy and safety of DA-1229 compared to placebo in patients with calcific aortic valve disease with…
- Trial name
- NCT05143177
- Testing
- Evogliptin
- Where
- 25 sites in United States, Canada
- Volunteers
- 486 people
- Sponsor
- REDNVIA Co., Ltd.