Clinical trials: Heart-Assist Devices
Heart Failure
Biological Markers Predicting Exercise Capacity in CF-LVAD Patients.
Establishing the association between biological markers and exercise capacity in continuous-flow left ventricular assist device patients.
- Trial name
- NCT02303236
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Gather Feasibility Data and User Feedback on Use of a Device in Vivo on Pregnant Volunteers in Their 2nd and 3rd Trimester
Vscan Access R2 Feasibility Evaluation
This study is being done to evaluate if the Vscan Access R2 Ultrasound System can measure Fetal Heart Rate (FHR) in humans when compared against a reference device (GE Corometrics 170 Series Fetal Monitor), and to gather feedback…
- Trial name
- NCT03617419
- Testing
- GE VScan Access R2 Ultrasound System, GE Corometrics 170 Series Fetal Monitor
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Left Ventricular Assist Device
Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device
To evaluate the concept of dynamic pump speed optimization based on the echocardiographic assessment of aortic valve opening during cardiopulmonary exercise test.
- Trial name
- NCT05063006
- Testing
- Cardiopulmonary exercise tests with maintained baseline optimal pump speed settings., Cardiopulmonary exercise test with gradually increased pump speed depending on live echocardiographic imaging.
- Where
- Poland
- Volunteers
- 22 people
- Sponsor
- Karol Wierzbicki
Heart Failure
Study of Anginera in Adults With a Left Ventricular Assist Device (LVAD) as Bridge to Transplant
The purpose of this study is to obtain human heart tissue after treatment with Anginera to determine its effect on a variety of things that might indicate improvement in heart function.
- Trial name
- NCT00364598
- Testing
- Anginera, a human tissue replacement therapy
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Theregen, Inc.
Heart Failure, Heart-assist Devices
PCORI-1310-06998 Trial of a Decision Support Intervention for Patients and Caregivers Offered Destination Therapy Heart Assist Device
The left ventricular assist device (LVAD) is growing rapidly among people dying from end-stage heart failure who are unable to get a heart transplant.
- Trial name
- DECIDE-LVAD (NCT02344576)
- Testing
- DT LVAD Decision Support Intervention
- Where
- 6 sites in United States
- Volunteers
- 445 people
- Sponsor
- University of Colorado, Denver
Cardiomyopathy, Cardiovascular Disease
Employing End Tidal Capnography in Continuous Flow Ventricular Assist Device Patients
The purpose of this study is to explore how the End Tidal Carbon Dioxide monitoring via nasal cannula (ETCO2-NC) device may allow for earlier detection of respiratory complications.
- Conditions
- Cardiomyopathy, Cardiovascular Disease, Heart Disease
- Trial name
- NCT02838355
- Testing
- Respiratory Depression Monitoring with End Tidal Carbon Dioxide Nasal Cannula (ETCO2- NC), Standard Non-invasive Respiratory Depression Monitoring
- Where
- United States
- Sponsor
- Emory University
Congestive Heart Failure
Heart Failure Monitoring With a Portable Ultrasound Device With Artificial Intelligence Assisted Tools: A Multi-Phase Observational Feasibility Study
The primary objective of this study is to evaluate the feasibility of a novel app to facilitate heart failure patients to acquire lung ultrasound images and evaluate the quality of those images to expert scans, and to evaluate…
- Trial name
- NCT05594940
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Butterfly Network
Heart Failure, Cardiomyopathies
The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support
The purpose of this observational study is to evaluate the performance of the Berlin Heart EXCOR Active driving unit while being used with the approved EXCOR ventricular assist device system.
- Conditions
- Heart Failure, Cardiomyopathies, Ventricular Dysfunction, Heart Diseases
- Trial name
- E-Motion (NCT04634708)
- Testing
- No intervention
- Where
- Germany
- Volunteers
- 24 people
- Sponsor
- Berlin Heart GmbH
Aortic Regurgitation, Aortic Valve Insufficiency
The JenaValve ALIGN-AR LVAD Registry
To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically…
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
- Trial name
- JENA-VAD (NCT06594705)
- Testing
- JenaValve Trilogy Heart Valve System
- Where
- 14 sites in United States
- Volunteers
- 50 people
- Sponsor
- JenaValve Technology, Inc.
Heart Failure
3D Assessment of RV Function in Patients Undergoing LVAD Implantation
This goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during left ventricular assist device (LVAD) implantation.
- Trial name
- NCT05376254
- Where
- Canada
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Alberta
End-Stage Heart Failure, Cardiomyopathies
VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial
The purpose of this trial is to determine the safety and feasibility of the VentrAssist LVAD in providing circulatory support for patients who require an LVAD as a bridge to cardiac transplantation.
- Trial name
- NCT00490347
- Testing
- VentrAssist Left Ventricular Assist Device
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Ventracor
Congestive Heart Failure
The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation
The purpose of this study is to assess the utility of nitric oxide for inhalation during left ventricular assist device (LVAD) implantation following cardiopulmonary bypass (CPB).
- Trial name
- NCT00060840
- Testing
- Nitric Oxide, Nitrogen
- Where
- 11 sites in United States, Germany and 1 more
- Volunteers
- 150 people
- Sponsor
- Mallinckrodt
Advanced Heart Failure
DuoCor 2 DOMINATE Study
Advanced heart failure is a life-threatening condition characterized by the inability of one or both ventricles to maintain adequate blood circulation.
- Trial name
- NCT07233876
- Testing
- DuoCor Ventricular Assist System
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
Heart Failure
Safety and Performance Evaluation of CircuLite Synergy
The purpose of the study is to demonstrate the safety and functionality of the CircuLite Synergy Pocket Circulatory Assist Device.
- Trial name
- NCT00878527
- Testing
- CircuLite Synergy Pocket Circulatory Assist Device
- Where
- 11 sites in Belgium, Germany and 3 more
- Volunteers
- 63 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Creation of a Digital Heart Failure Registry Using a Novel Mobile Health Platform: HUGO-HF
The investigators goal is to create a digital registry that allows for seamless integration of patient reported outcomes, electronic health record data, and pharmacy information into data collection.
- Trial name
- HUGO-HF (NCT03810638)
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- Yale University
Aortic Valve Regurgitation Acquired
Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding in Vivo Model of Valvular Heart Diseases
To investigate histological structure and molecular changes involved on the onset of AVD after left ventricular assist device (LVAD) implantation and to compare them with those of patients operated on for severe aortic…
- Trial name
- NCT03279029
- Testing
- blood samples, biopsy
- Where
- France
- Volunteers
- 15 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Tricuspid Valve Insufficiency, Right Heart Failure
Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation Study
The purpose of this study is to determine the utility of tricuspid valve repair at the time of LVAD implantation for patients presenting with moderate or severe tricuspid regurgitation.
- Conditions
- Tricuspid Valve Insufficiency, Right Heart Failure, Heart Failure
- Trial name
- TVVAD (NCT03775759)
- Testing
- Tricuspid valve repair or replacement, Medical management of tricuspid regurgitation
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- Duke University
Post Cardiac Surgery, Sternal Closure
TORQ Clinical Study
The proposed trial is to evaluate the use of the TORQ closure assistance device and how it affects pain in the sternum, breathing and quality of life compared to traditional use of needle drivers or similar to close sternal wires.
- Trial name
- TORQClin (NCT01647178)
- Testing
- TORQ assisted sternal closure, Conventional closure
- Where
- Canada
- Volunteers
- 92 people
- Sponsor
- Kardium Inc.
Heart Failure
Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan
The purpose of the study is to evaluate the safety and effectiveness of the HW005 System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.
- Trial name
- HW005 (NCT02091440)
- Testing
- Implant of the HW005 Ventricular Assist System.
- Where
- 5 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
High-risk Percutaneous Coronary Intervention
Magenta Elevate™ EFS in High-Risk PCI Patients
The Elevate™ EFS study is designed to evaluate the safety and feasibility of the Magenta Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary…
- Trial name
- NCT05727059
- Testing
- The Elevate™ System
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Magenta Medical Ltd.