Clinical trials: Left Ventricular Assist Devices
Chronic Heart Failure
The IMPULSE Study: Pilot
Continuous-flow (CF) left ventricular assist devices (LVADs) are an important tool in the treatment of end-stage heart failure, affording patients significantly improved quantity and quality of life.
- Trial name
- IMPULSE (NCT02044471)
- Testing
- Remote Ischemic Conditioning (using Sphygmomanometer)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Baylor College of Medicine
Congestive Heart Failure, Cardiorenal Syndrome
Nesiritide and Renal Function After the Total Artificial Heart
The prevalence of renal dysfunction after implantation of the artificial heart is high. The infusion of exogenous B-type natriuretic peptide (BNP) after implantation of the total artificial heart (TAH) improves renal function in…
- Trial name
- NCT01836809
- Testing
- nesiritide
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Virginia Commonwealth University
Heart Failure, Right Ventricular Dysfunction
Mitigating Post-Op RV Dysfunction After LVAD Implantation
This project evaluates right ventricle (RV) protective strategies after left ventricular assist device (LVAD) implantation.
- Conditions
- Heart Failure, Right Ventricular Dysfunction, Right Ventricular Failure
- Trial name
- NCT05758194
- Testing
- Standardized RV Management, Usual Care RV Management
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Chicago
End Stage Heart Failure
Impact of LVAD Implantation on Micro- and Macrovascular Function
End stage heart failure is characterized by a critical inability of the heart to meet the organism's blood demand even under resting conditions.
- Trial name
- LVAD (NCT02174133)
- Where
- Germany
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
Anticoagulation, Left Ventricular Assist Device
Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II Left Ventricular Assist System (LVAS) (TRACE)
The purpose of this observational study is to obtain multi-center data on HeartMate II (HMII) patients managed with reduced anticoagulation or anti-platelet regimes, and the incidence of thrombotic and bleeding adverse events…
- Trial name
- TRACE (NCT01477528)
- Where
- 18 sites in United States, Austria and 3 more
- Volunteers
- 201 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Left-Sided, Heart Failure, Right-Sided
Central and Cerebral Circulation in Early Stages After LVAD Implantation
This trial will evaluate patients with a mechanical Left Ventricular Assist Device (LVAD) in early stages after surgical implantation.
- Trial name
- ECOH3 (NCT03087669)
- Testing
- LVAD flow velocity setting-Rounds per Minute(RPM) on HeartMate III®, MAP intervention using Noradrenalin
- Where
- Sweden
- Volunteers
- 20 people
- Sponsor
- Sahlgrenska University Hospital
Advanced Refractory Left Ventricular Heart Failure
MOMENTUM 3 Continued Access Protocol
The objective of the study is to continue to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the…
- Trial name
- MOMENTUM 3 CAP (NCT02892955)
- Testing
- HeartMate 3 LVAS
- Where
- 69 sites in United States
- Volunteers
- 1,685 people
- Sponsor
- Abbott Medical Devices
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
End Stage Heart Disease
Early Versus Emergency Left Ventricular Assist Device Implantation in Patients Awaiting Cardiac Transplantation
The aim of the study is to assess whether, in patients who are listed for cardiac transplantation in transplantable (T) status, early implantation of a left ventricular assist device is superior to the current therapeutic…
- Trial name
- NCT02387112
- Testing
- Early VAD implantation
- Where
- 18 sites in Germany
- Volunteers
- 102 people
- Sponsor
- German Heart Institute
Heart Failure, Gut Microbiome
Enhanced Nutritional Optimization in LVAD Trial
The goal of this clinical trial is to assess whether a peri-operative intervention with nutritional immune modulating intervention (Ensure Surgery Immunonutrition shake) has beneficial effects on the complex interplay between gut…
- Conditions
- Heart Failure, Gut Microbiome, Nutritional Deficiency
- Trial name
- ENOL (NCT05655910)
- Testing
- Ensure Surgery Immunonutrition shake
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
Heart Failure, Cardiovascular Disease
HeartMate 3™ LIS Study
The purpose of this study is to evaluate a less invasive implantation technique of the HeartMate 3 Left Ventricular Assist System (HM 3 LVAS) in 10 patients.
- Trial name
- HM 3 LIS (NCT02475460)
- Testing
- Less Invasive Surgery (LIS), HeartMate 3™
- Where
- 3 sites in Czechia, Germany
- Volunteers
- 13 people
- Sponsor
- Abbott Medical Devices
Continous Flow Left Ventricular Device
Impact of Hemodynamic Ramp Test-Guided HVAD RPM and Medication Adjustments on Exercise Tolerance and Quality of Life
The main purpose of this study is to compare Echo-guided testing to the Hemodynamic-Echo Ramp Tests to determine which method of testing provides better information for adjusting pump speed and medical treatment for Left…
- Trial name
- Ramp-it-Up (NCT03021239)
- Testing
- Echo Guided Testing, Hemodynamic-Echo Ramp Testing -
- Where
- 8 sites in United States
- Volunteers
- 40 people
- Sponsor
- University of Chicago
Congestive Heart Failure
Baroreflex Activation Therapy in Left Ventricular Assist Device Patients Study
This study will involve LVAD patients who have already received a clinically-indicated BAT (BAROSTIM) device. After recovery from LVAD implant, we will investigate the effects of BAT in a double-blind cross-over study design.
- Trial name
- BAT-VAD (NCT06195046)
- Testing
- Baroreflex Activation Therapy (BAT)
- Sponsor
- Medical University of South Carolina
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.
Bleeding, Clot Blood
Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device
Heart failure is a world epidemic. LVADs are increasingly used as they have demonstrated improved survival rates compared to optimal medical management.
- Trial name
- NCT06655376
- Testing
- Aspirin, Warfarin
- Where
- 3 sites in United States
- Volunteers
- 128 people
- Sponsor
- Columbia University
Left Ventricular Assist Device, Physical Therapy
The Effect of Physical Therapy Intervention in Patients With Left Ventricular Assistive Device on Physical Function
To retrospectively investigate the effect of physical therapy intervention on improving physical function of patients post left ventricular assist device (LVAD) through electronic medical record survey
- Trial name
- LVAD (NCT03636815)
- Testing
- physical therapy
- Where
- Taiwan
- Volunteers
- 62 people
- Sponsor
- National Taiwan University Hospital
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
End-stage Heart Failure, Cardiomyopathies
VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial
The purpose of this study is to evaluate the safety and effectiveness of VentrAssistTM LVAD in individuals who are awaiting heart transplants.
- Trial name
- NCT00483197
- Testing
- VentrAssistTM Left Ventricular Assist Device
- Where
- 29 sites in United States
- Volunteers
- 140 people
- Sponsor
- Ventracor
Left Ventricular Assist Device, End-stage Heart Failure
Preoperative Nutritional Optimization and Physical Exercise for Patients Scheduled for Elective Implantation for a Left-Ventricular Assist Device
This is a pilot, randomized, multicenter interventional trial of a combined preoperative oral nutritional support (ONS) and physical exercise therapy in patients planned for elective implantation of a left-ventricular assist…
- Conditions
- Left Ventricular Assist Device, End-stage Heart Failure, Cardiac Surgery
- Trial name
- PROPER-LVAD (NCT04205760)
- Testing
- Nutrition + exercise
- Where
- 5 sites in Germany
- Volunteers
- 40 people
- Sponsor
- RWTH Aachen University
High-Risk Percutaneous Coronary Intervention
Magenta Elevate™ First-in-Human Clinical Study in High-Risk PCI Patients
The Elevate™ First-In-Human (FIH) study is designed to evaluate the initial safety and device functionality of the Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk…
- Trial name
- ELEVATE I (NCT06099548)
- Testing
- The Elevate™ System
- Where
- 2 sites in Georgia
- Volunteers
- 20 people
- Sponsor
- Magenta Medical Ltd.