Pharmaceutical sponsor
Edwards Lifesciences Clinical Trials
Studies where Edwards Lifesciences is the lead sponsor: its pipeline by phase, what is enrolling now and where. Studies it supports as a collaborator are in the search.
In numbers
Open to volunteers: recruiting, not yet recruiting or enrolling by invitation. Active adds studies under way that have stopped recruiting.
Open to volunteers
All 20Heart 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
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
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
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 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
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
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the INNOVALVE System Trial - Early Feasibility Study
Study to evaluate the safety and performance of the INNOVALVE system
- Trial name
- TWIST-EFS (NCT04919980)
- Testing
- INNOVALVE system
- Where
- 21 sites in United States
- Volunteers
- 85 people
- Sponsor
- Edwards Lifesciences
Completed, with results posted
All 41Tricuspid Regurgitation
Edwards CLASP TR EFS
Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation
- Trial name
- CLASP TR EFS (NCT03745313)
- Testing
- Edwards PASCAL Transcatheter Valve Repair System
- Where
- 15 sites in United States
- Volunteers
- 65 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis, Mitral Stenosis
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their…
- Conditions
- Aortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- COMMENCE (NCT01757665)
- Testing
- Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
- Where
- 32 sites in United States, Canada and 1 more
- Volunteers
- 777 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Regurgitation
The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.
- Trial name
- CLASP (NCT03170349)
- Testing
- Mitral Valve Repair
- Where
- 17 sites in United States, Australia and 5 more
- Volunteers
- 124 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis, Symptomatic Aortic Stenosis
China S3: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 THV in the Chinese Population
To evaluate the safety and effectiveness of the SAPIEN 3 (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
- NCT03466918
- Testing
- SAPIEN 3 THV with the Commander delivery system
- Where
- 4 sites in China
- Volunteers
- 58 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis, Aortic Valve Stenosis
SAPIEN 3 Ultra EU PMS
This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating…
- Trial name
- NCT04860752
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 37 sites in Austria, Finland and 8 more
- Volunteers
- 500 people
- Sponsor
- Edwards Lifesciences