Clinical trials: Aortic Stenosis Symptomatic
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
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 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
Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted very high risk and high risk for aortic…
- Trial name
- NCT01531374
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 45 sites in United States
- Volunteers
- 2,777 people
- Sponsor
- Medtronic Cardiovascular
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
Severe Aortic Stenosis
Colibri Transcatheter Aortic Heart Valve System Study
The Colibri Heart Valve clinical investigation ("COL-01") is a prospective, multicenter, exploratory single arm and controlled clinical investigation compared to recent historical results.
- Trial name
- NCT04029844
- Testing
- Colibri TAVI System
- Where
- 5 sites in France, United Kingdom
- Volunteers
- 30 people
- Sponsor
- Colibri Heart Valve LLC
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or…
- Trial name
- NCT01240902
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR)
- Where
- 45 sites in United States
- Volunteers
- 1,453 people
- Sponsor
- Medtronic Cardiovascular
Aortic Stenosis Symptomatic
ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2011-03)
First-In-Man Study on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human feasibility data pertaining to the safety and performance of the device.
- Trial name
- 2011-03 (NCT03752996)
- Testing
- ACURATE TF™ Aortic Valve System
- Where
- 5 sites in Brazil, Germany
- Volunteers
- 140 people
- Sponsor
- Symetis SA
Aortic Valve Stenosis
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for…
- Trial name
- NCT03517436
- Testing
- TAVR with CENTERA THV
- Where
- 23 sites in United States
- Volunteers
- 101 people
- Sponsor
- Edwards Lifesciences
Transcatheter Aortic Valve Replacement, Severe Symptomatic Calcified Native Aortic Valve Stenosis
Sentinel(TM) Post-Market Registry
The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve stenosis indicated for TAVR.
- Trial name
- NCT02255851
- Testing
- SENTINEL (Cerebral Protection System)
- Volunteers
- 300 people
- Sponsor
- Claret Medical
Symptomatic Severe Aortic Stenosis
Portico Next Generation Approval Study
The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the…
- Trial name
- NCT04011722
- Testing
- Portico™ NG (Navitor) Valve and FlexNav™ Delivery System, Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
- Where
- 28 sites in United States, Australia and 3 more
- Volunteers
- 333 people
- Sponsor
- Abbott Medical Devices
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
Hypertrophic Cardiomyopathy
Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER
This is a multicenter open-label study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM) who previously participated in study MYK-461-004 (PIONEER-HCM).
- Trial name
- PIONEER-OLE (NCT03496168)
- Testing
- mavacamten
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- Bristol-Myers Squibb
Symptomatic Obstructive Hypertrophic Cardiomyopathy, Healthy Subjects
A Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult Subjects
The purposes of this study are to: 1. Learn about the safety of CK-3773274 after a single dose and multiple doses in healthy subjects. 2. Learn how healthy subjects tolerate CK-3773274 after a single dose and multiple doses. 3.
- Trial name
- NCT03767855
- Testing
- CK-3773274 - Granules in Capsule, CK-3773274 - Tablets
- Where
- United States
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Cytokinetics
Aortic Stenosis Symptomatic
Feasibility Trial on ACURATE™ Transapical Implantation in Patients With Severe Symptomatic Aortic Stenosis (2009-01)
Feasibility Trial on the ACURATE TA™ transapical implantation in patients presenting severe symptomatic aortic stenosis to collect human feasibility data pertaining to the safety and performance of the device.
- Trial name
- TA-FIM (NCT03567278)
- Testing
- ACURATE TA™
- Where
- 5 sites in Germany
- Volunteers
- 40 people
- Sponsor
- Symetis SA
Transcatheter Aortic Valve Replacement
Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System
This study was designed to preliminary verify the safety and of efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System With accessories in patients with symptomatic, calcified and severe aortic stenosis using…
- Trial name
- NCT05202977
- Testing
- SinocrownTM Transcatheter Aortic Valve Replacement System
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
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 Symptomatic
Siegel™ Transcatheter Aortic Valve Replacement System (TAVR) Early Feasibility Study
The Siegel™ Transcatheter Aortic Valve (TAVR) early feasibility study objective is to assess the acute and long-term safety and feasibility of the Siegel TAVR device in adult subjects with symptomatic, severe native aortic…
- Trial name
- NCT06680427
- Testing
- Siegel Transcatheter Aortic Valve (TAVR)
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- MiRus
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