Clinical trials: sponsored by Edwards Lifesciences
Subarachnoid Hemorrhage, Aneurysmal
Continuous Assessment of Brain Blood Perfusion in Subarachnoid Hemorrhage Patients Using Near-Infrared Spectroscopy (NIRS)
The goal of this observational study is to continuously assess cerebral autoregulation in patients with subarachnoid hemorrhage (SAH) using cerebral oximetry index (COx) and hemoglobin volume reactivity index (HVx).
- Trial name
- NCT06932640
- Testing
- - Non-Invasive Near-infrared Spectroscopy (NIRS) device (HEM1 with Foresight Elite Sensor)
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Alabama at Birmingham
Heart Valve Diseases, Heart Diseases
TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)
TRIBLAZE is a prospective, observational, single-arm, multicenter study designed to collect real-world clinical outcomes in a minimum of 75 participants who will receive the Edwards Lifesciences TRIFORMIS RESILIA surgical…
- Conditions
- Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Tricuspid Valve Disease
- Trial name
- TRIBLAZE (NCT07684313)
- Testing
- Edwards TRIFORMIS RESILIA heart valve
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation
Double Transseptal Guide Sheath to Prevent Dock Drop During SAPIEN M3 Transcatheter Mitral Valve Replacement
This study looks at a heart procedure called transcatheter mitral valve replacement. Doctors use a device called SAPIEN M3 to replace a damaged heart valve.
- Trial name
- DGS-M3 (NCT07878195)
- Where
- Austria
- Volunteers
- 77 people
- Sponsor
- Medical University of Vienna
Congenital Heart Disease
Autus Valve Continued Access Study (CAS)
Prospective, single-arm, multi-center, continued access study of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement.
- Trial name
- NCT07466745
- Testing
- Pulmonary Valve Replacement Surgery
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Edwards Lifesciences
Congenital Heart Disease
Autus Valve Pivotal Study
Prospective, single-arm, multi-center study to evaluate safety and effectiveness of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement.
- Trial name
- NCT05006404
- Testing
- Pulmonary Valve Replacement Surgery
- Where
- 12 sites in United States
- Volunteers
- 62 people
- Sponsor
- Edwards Lifesciences
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow…
- Conditions
- Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease
- Trial name
- NCT03130777
- Testing
- Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
- Where
- 14 sites in United States
- Volunteers
- 86 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Rationale: Transcatheter aortic valve implantation (TAVI) has become the standard of care for aortic stenosis across all surgical risk categories, including low-risk, younger patients (≥70 years).
- Conditions
- Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening, Valve Expansion, Transcatheter Aortic Valve Replacement
- Trial name
- SYMMETRY (NCT07872020)
- Testing
- Double-TAP post-dilatation
- Where
- 5 sites in Germany, Netherlands
- Volunteers
- 422 people
- Sponsor
- Erasmus Medical Center
Structural Valve Deterioration, Structural Valve Degeneration
The ReTAVI Prospective Observational Registry
Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger \& lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a…
- Conditions
- Structural Valve Deterioration, Structural Valve Degeneration, Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure, Prosthetic Valve Malfunction
- Trial name
- NCT05601453
- Testing
- Elective redo transcatheter aortic valve implantation (redo-TAVI)
- Where
- 62 sites in Austria, Canada and 9 more
- Volunteers
- 250 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Tricuspid Regurgitation, Tricuspid Insufficiency
Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)
The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.
- Trial name
- TriBAND (NCT03779490)
- Testing
- Transcatheter Tricuspid Valve Repair
- Where
- 14 sites in Germany, Spain and 1 more
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
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
Tricuspid Regurgitation, Heart Valve Diseases
The CLASP III TR CED Study
This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair procedure using the…
- Conditions
- Tricuspid Regurgitation, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT07859709
- Testing
- PASCAL Precision system Treated, Medicare Eligible Untreated Patients
- Where
- United States
- Volunteers
- 2,350 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation, Mitral Valve Insufficiency
The ENCIRCLE Trial
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are…
- Trial name
- ENCIRCLE (NCT04153292)
- Testing
- SAPIEN M3 valve and dock
- Where
- 54 sites in United States, Australia and 4 more
- Volunteers
- 786 people
- Sponsor
- Edwards Lifesciences
Heart Failure
Early Feasibility Study of the Edwards APTURE Transcatheter Shunt System
The objectives of this early feasibility study are to: evaluate initial clinical safety, device functionality, and effectiveness of the APTURE system for treatment of symptomatic HFrEF patients with elevated LAP, provide guidance…
- Trial name
- ALT-FLOW HFrEF (NCT07858799)
- Testing
- Edwards APTURE transcatheter shunt system
- Where
- 3 sites in Germany
- Volunteers
- 15 people
- Sponsor
- Edwards Lifesciences
Pulmonary Valve Insufficiency, Complex Congenital Heart Defect
ALTERRA Post-Approval Study
This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
- Conditions
- Pulmonary Valve Insufficiency, Complex Congenital Heart Defect, Tetralogy of Fallot, Pulmonary Regurgitation
- Trial name
- NCT05378386
- Testing
- Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System
- Where
- 24 sites in United States, Israel
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
Heart Failure
Early Feasibility Study - Edwards APTURE Transcatheter Shunt System
The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards APTURE transcatheter shunt system.
- Trial name
- ALT-FLOW US (NCT03523416)
- Testing
- Edwards APTURE transcatheter shunt system
- Where
- 19 sites in United States
- Volunteers
- 90 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 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
Tricuspid Regurgitation
TTVR STRONG Under Coverage With Evidence Development (CED) Study
This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Replacement procedure using the…
- Trial name
- STRONG (NCT06833476)
- Testing
- EVOQUE
- Where
- United States
- Volunteers
- 2,044 people
- Sponsor
- Edwards Lifesciences
Structural Heart Abnormality, Valve Heart Disease
Capitalizing on AI to CapTure Undiagnosed Structural Heart Disease
Doctors are testing a new tool called EchoNext to see if it can help find heart problems earlier. EchoNext looks at the heart's electrical test, called an ECG, and uses artificial intelligence (AI) to check for signs of…
- Conditions
- Structural Heart Abnormality, Valve Heart Disease, Heart Diseases, Cardiovascular Diseases
- Trial name
- CACTUS (NCT07843004)
- Testing
- EHR Alert
- Where
- United States
- Volunteers
- 4,000 people
- Sponsor
- Pierre Elias