Clinical trials: sponsored by Edwards Lifesciences
Mitral Insufficiency, Heart Valve Disease
Early Feasibility Study of the CardiAQ™ TMVI System (Transfemoral and Transapical DS)
The purpose of the study is to generate early US feasibility data of the CardiAQ™ Transcatheter Mitral Valve Implant System. The study will enroll patients with moderate to severe mitral valve regurgitation who are considered…
- Conditions
- Mitral Insufficiency, Heart Valve Disease, Cardiovascular Disease, Heart Disease
- Trial name
- NCT02515539
- Testing
- CardiAQ TMVI System (Transapical & Transfemoral DS)
- Sponsor
- Edwards Lifesciences
Intensive Care Unit Blood Glucose Monitoring
GlucoClear ICU Study
The primary purpose of this Study is evaluation of the safety and accuracy of the GlucoClear CGM System.
- Trial name
- NCT02238041
- Testing
- GlucoClear System
- Sponsor
- Edwards Lifesciences
Acute CHF, Acute Stroke Syndromes
PREMIUM Registry: PRognostic HEModynamIc Profiling in the AcUtely Ill EMergency Department Patient
This multinational registry (3 USA, 2 European centers) will capture in the ED continuous non invasive hemodynamic monitoring (using Nexfin finger cuff technology) of patients presenting with acute heart failure, stroke syndromes…
- Conditions
- Acute CHF, Acute Stroke Syndromes, Systemic Infections
- Trial name
- PREMIUM (NCT01208077)
- Where
- 4 sites in United States, Italy and 1 more
- Volunteers
- 514 people, healthy volunteers welcome
- Sponsor
- Henry Ford Health System
Mitral Leaflet Prolapse
V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
The V-Chordal System is a new technology for mitral repair. The Valtech V-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" to achieve an optimal coaptation.
- Trial name
- NCT01415947
- Testing
- V Chordal
- Where
- Italy
- Volunteers
- 5 people
- Sponsor
- Edwards Lifesciences
Accurate Blood Glucose Monitoring in Critical Care Setting
GlucoClearTM System ICU Study
The primary purpose of this Study is evaluation of the safety and performance of the GlucoClear System (System). The primary safety objective will be assessed by: Evaluation of any serious adverse device effects upon Sensor…
- Trial name
- NCT02094859
- Where
- 2 sites in Austria, Belgium
- Volunteers
- 50 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Replacement
Comparison Between Three Types of Stented Pericardial Aortic Valves
This study suggests for the first time a comparison of the hemodynamic performance of the two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available since September 2010 at the University…
- Trial name
- NCT01522352
- Testing
- Aortic valve replacement by bioprosthesis
- Where
- France
- Volunteers
- 165 people
- Sponsor
- University Hospital, Clermont-Ferrand
Blood Glucose
Clinical Study of the Intravenous Blood Glucose System in Hospitalized Adult Elective or Non-Emergent Surgery and Medical/Surgical Intensive Care Unit Patients
The primary objective of this study is to evaluate the performance and safety of the intravenous blood glucose (IVBG) System relative to point of care (POC) meter performance when each method is compared to the Yellow Springs…
- Trial name
- NCT00906490
- Testing
- Intravenous Blood Glucose monitoring system
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Cardiac Output and Preload Assessment, Lung Water Assessment
Clinical Evaluation of a New Transpulmonary Thermodilution Method to Assess Thermodilution Cardiac Output, Global End Diastolic Volume and Extravascular Lung Water
The primary objective of this study is to obtain the TPTD, GEDV and EVLW measurements from existing indwelling femoral arterial Volume View™ catheter and central venous catheters.
- Trial name
- NCT01405040
- Where
- 4 sites in Germany, Switzerland
- Volunteers
- 97 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Regurgitation, Congestive Heart Failure
Effects of Mitral Valve Repair With the Geoform Ring on Cardiomyopathy
The primary aim of this study is to assess the changes on the shape and function of the left ventricle in patients with severe mitral valve regurgitation due to congestive heart failure and cardiomyopathy who undergo mitral valve…
- Conditions
- Mitral Valve Regurgitation, Congestive Heart Failure, Cardiomyopathy
- Trial name
- NCT00428103
- Testing
- 3 dimensional echocardiography
- Where
- United States
- Sponsor
- Juan Crestanello, MD
Cardiac Output, High, Cardiac Output, Low
Using Minimally Invasive Cardiac Output Data vs. Standard Care for Patients Emergently Admitted to the Intensive Care Unit Who Are Hemodynamically Unstable
The purpose of this study is to evaluate if the continuous availability of minimally invasive cardiac output data during treatment in the intensive care unit (ICU) for hemodynamic instability, in comparison to standard of care…
- Trial name
- NCT00354211
- Testing
- minimally invasive cardiac output system consisting of arterial line sensor and cardiac output bedside monitor (device)
- Where
- 3 sites in Finland, Switzerland
- Volunteers
- 392 people
- Sponsor
- Edwards Lifesciences
Severe Degenerative Mitral Regurgitation
Predictors of Postoperative Left Ventricular Function in Patients Undergoing Mitral Valve Repair for Severe Degenerative Mitral Regurgitation
The aim of the study is to investigate whether a predictive score (combination of several validated predictors) better predicts postoperative left ventricular function than any single predictor in patients undergoing mitral valve…
- Trial name
- NCT01519050
- Testing
- mitral valve repair
- Where
- Switzerland
- Volunteers
- 100 people
- Sponsor
- University of Zurich
Esophageal Diseases, Gastrointestinal Diseases
Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy
The purpose of this study is to determine whether the early identification and more precise intervention of operating room (OR) patient fluid administration optimization using arterial pressure-based cardiac output (APCO) yields…
- Conditions
- Esophageal Diseases, Gastrointestinal Diseases, Disorder of the Genitourinary System, Gynecologic Diseases
- Trial name
- NCT00526331
- Testing
- Vigileo Monitor, FloTrac Sensor
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- M.D. Anderson Cancer Center
Cardiac Output, High, Cardiac Output, Low
Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone
The purpose of this study is to compare changes of minimally invasive arterial pulse contour cardiac output with changes of intermittent and continuous thermodilution cardiac output by pulmonary artery catheter in hemodynamic…
- Conditions
- Cardiac Output, High, Cardiac Output, Low, Vasodilation, Vasoconstriction
- Trial name
- NCT00583687
- Testing
- Vigileo TM / Flotrac TM (Minimally invasive cardiac output system consisting of arterial line sensor and cardiac output monitor), Passive leg raising, Volume challenge / Change of vasoactive drugs or inotropics
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern