Clinical trials: sponsored by Edwards Lifesciences
Tricuspid Valve Regurgitation, Heart Valve Diseases
TRISCEND JAPAN Study
A prospective, open, non-randomized, multicenter, clinical trial to evaluate the safety and effectiveness of the Edwards EWJ-202 transcatheter tricuspid valve replacement system in the treatment of patients with at least severe…
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- TRISCEND JAPAN (NCT05760989)
- Testing
- Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System
- Where
- 8 sites in Japan
- Volunteers
- 53 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
Tricuspid 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
Cardiopulmonary Bypass Surgery
HPI (Hypotension Prediction Index) Care Trial
A prospective single-center randomized controlled trial to determine if guided hemodynamic management with the Acumen HPI technology in the OR and ICU can reduce the mean duration of hypotension in cardiac surgery patients…
- Trial name
- NCT05083403
- Testing
- AcumenTM HPI Software Feature, Non-protocolized Standard of Care
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Edwards Lifesciences
Tricuspid Valve Regurgitation, Heart Valve Diseases
2019-06 TRISCEND Study
Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- NCT04221490
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 20 sites in United States, Canada and 2 more
- Volunteers
- 228 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
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
- Trial name
- P3 (NCT02675114)
- Testing
- SAVR, SAPIEN 3 THV
- Where
- 77 sites in United States, Australia and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Edwards Lifesciences
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
Mitral Valve Insufficiency, Mitral Valve Disease
PARTNER 3 Trial - Mitral Valve in Valve
To assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Disease, Mitral Valve Regurgitation, Heart Failure
- Trial name
- NCT03193801
- Testing
- Edwards SAPIEN 3 transcatheter valve, Model 9600TFX
- Where
- 12 sites in United States, Australia and 1 more
- Volunteers
- 53 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
Aortic Valve Stenosis
The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.
- Trial name
- NCT03471065
- Testing
- SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV
- Where
- 6 sites in Canada, United Kingdom
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Coronary Artery Disease, Mitral Valve Regurgitation
Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol
The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards® PERIMOUNT Magna Mitral Valves in patients undergoing mitral valve replacement with or without concomitant procedures…
- Conditions
- Coronary Artery Disease, Mitral Valve Regurgitation, Mitral Valve Incompetence, Heart Failure
- Trial name
- NCT00853632
- Testing
- CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES
- Where
- 15 sites in United States, Austria and 2 more
- Volunteers
- 329 people
- Sponsor
- Edwards Lifesciences
Symptomatic Severe Aortic Stenosis
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, and severe aortic…
- Trial name
- PII S3i (NCT03222128)
- Testing
- TAVR
- Where
- 51 sites in United States
- Volunteers
- 1,074 people
- Sponsor
- Edwards Lifesciences
Pediatric ALL
Pediatric Cardiac Output Monitoring Observational Study
To assess Cardiac Output Monitoring in pediatric subjects by comparing FloTrac and ClearSight system to intermittent thermodilution Swan-Ganz, in order to expand the indications of FloTrac, ClearSight and Swan-Ganz thermodilution…
- Trial name
- POGO (NCT04465370)
- Testing
- Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight
- Where
- 3 sites in United States
- Volunteers
- 89 people
- Sponsor
- Edwards Lifesciences
Non-Cardiac/ Non-Thoracic Surgery, Abdominal Surgery
Assisted Fluid Management IDE Study
The primary objective of this study is to evaluate the performance of the Acumen™ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness.
- Conditions
- Non-Cardiac/ Non-Thoracic Surgery, Abdominal Surgery, Pelvic Surgery, Major Peripheral Vascular Surgery
- Trial name
- AFM (NCT03469570)
- Testing
- EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature
- Where
- 10 sites in United States
- Volunteers
- 330 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)
A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model: 9600TFX) in the treatment of symptomatic severe…
- Trial name
- NCT02903420
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 2 sites in Japan
- Volunteers
- 38 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Insufficiency
Edwards PASCAL Transcatheter Valve Repair System Registry
This registry will collect prospective and retrospective clinical data on patients treated with the Edwards PASCAL Transcatheter Valve Repair System outside of the Post-Market Clinical Follow-up (PMCF) study.
- Trial name
- PASCALRegistry (NCT04443218)
- Testing
- Edwards PASCAL Transcatheter Valve Repair System
- Where
- 14 sites in Germany, Switzerland
- Volunteers
- 220 people
- Sponsor
- Edwards Lifesciences
Moderate to High-risk Noncardiac Surgery
Hypotension Prediction Index (HPI) SMART-BP Trial
A multicenter, randomized comparison of intraoperative hemodynamic management with or without a protocolized strategy utilizing Hypotension Prediction Index (HPI) software guidance during moderate-to-high-risk noncardiac surgery.
- Trial name
- NCT05105477
- Testing
- AcumenTM HPI Software Feature, Non-protocolized Standard of Care
- Where
- 11 sites in United States
- Volunteers
- 407 people
- Sponsor
- Edwards Lifesciences