Clinical trials: Left Ventricular Assist Device, active
Type 2 Diabetes Mellitus, Hyperglycemia
A Study of Glycemic Control in Left Ventricular Assist
The study is being conducted to understand if the hemoglobin A1c, a measurement of control of blood sugars over a 3-month time, is valid in patients with Left Ventricular Assist Devices (LVADs) in place.
- Conditions
- Type 2 Diabetes Mellitus, Hyperglycemia, Hypoglycemia
- Trial name
- GLYCEM1C-LVAD (NCT05933161)
- Testing
- Freestyle Libre 3 Continuous Glucose Monitor (CGM)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Mayo Clinic
Heart Failure, Advanced Heart Failure
REACTION-VAD Trial: Remote Exercise Training Via Telemedicine in Patients With Long-Term Ventricular Assist Devices
Current international guidelines recommend that patients with a heart pump (left ventricular assist device, LVAD) participate in supervised exercise cardiac rehabilitation programs.
- Conditions
- Heart Failure, Advanced Heart Failure, Left Ventricular Assist Device, LVAD
- Trial name
- REACTION-VAD (NCT07611188)
- Testing
- Remote Physical Conditioning Program (Telerehabilitation), Usual care. No Remote Monitoring.
- Where
- 10 sites in Spain
- Volunteers
- 78 people
- Sponsor
- Puerta de Hierro University Hospital
Congestive Heart Failure
Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease
Hypothesis: Tissue and serum samples collected from end-stage heart failure patients receiving left ventricular assist device implantation (LVAD) or heart transplantation will provide information regarding the basic science of…
- Trial name
- NCT01099982
- Where
- 3 sites in United States
- Volunteers
- 300 people
- Sponsor
- University of Utah
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
LVAD (Left Ventricular Assist Device) Thrombosis, LVAD
STudy of Aspirin Removal in Patients Supported by the Fully Magnetically Levitated CH-VAD Pump
This multi-center, prospective, randomized, double-blinded, placebo-controlled study aims to investigate whether withdrawal of aspirin from the antithrombotic regimen in patients supported with the CH-VAD pump is non-inferior to…
- Conditions
- LVAD (Left Ventricular Assist Device) Thrombosis, LVAD, LVAD (Left Ventricular Assist Device), LVAD-related GI Bleed
- Trial name
- STAR (NCT07644247)
- Testing
- Warfarin (INR 2-3) with aspirin
- Volunteers
- 370 people
- Sponsor
- China National Center for Cardiovascular Diseases
High-Risk Percutaneous Coronary Intervention (High-risk PCI), Left Ventricular Assist Devices
Interventional Left Ventricular Assist System for PCI in CHIP Patients
Mechanical circulatory support (MCS) is a life-sustaining therapy first introduced in the 1950s. After six decades of development, it now serves as a critical bridge therapy for patients with acute cardiac events and end-stage…
- Trial name
- NCT07053618
- Testing
- Implantation of the VADLINK Percutaneous Left Ventricular Assist Device, VA-ECMO
- Where
- 15 sites in China
- Volunteers
- 286 people
- Sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTD
Arrythmia, Cardiomyopathies
The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients
To investigate the effect of VTA ablation at the time of LVAD implant to see if it can reduce the incidence of VTA after surgery
- Trial name
- PIVATAL (NCT05034432)
- Testing
- Intra-Op Prophylactic VT ablation, Conventional Management
- Where
- 19 sites in United States
- Volunteers
- 100 people
- Sponsor
- University of Rochester
Acute on Chronic Systolic Congestive Heart Failure, Cardiorenal Syndrome
Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD
Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic Heart Failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system…
- Trial name
- NEUTRALIZE-CRS (NCT03836482)
- Testing
- Selective Cytopheretic Device
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- SeaStar Medical
LVAD (Left Ventricular Assist Device)
Feasibility and Clinical Utility of Ambulatory Ultraslow Deflation Sphygmomanometers in LVAD Recipients - easiSLOW-LVAD Pilot
Prospective, single-arm feasibility study will evaluate the use of an ultraslow deflation automated sphygmomanometer (Terumo Elemano 2) for home BP monitoring in patients with continuous-flow LVADs.
- Trial name
- easiSLOW-LVAD (NCT07633561)
- Testing
- Ultraslow deflation cuff
- Volunteers
- 50 people
- Sponsor
- University of Florida
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.
Heart Failure
Cardiac Hemodynamics During Left Ventricular Assist
The goal of this observational study is to exploratively investigate intracardiac geometry and hemodynamics in patients with ongoing HeartMate 3-therapy in the Swedish Southeast Healthcare region.
- Trial name
- FlowVAD (NCT06115096)
- Where
- Sweden
- Volunteers
- 35 people
- Sponsor
- Region Östergötland
LVAD (Left Ventricular Assist Device) Driveline Infection
Non-invasive Detection of Driveline Infections in Patients with a Left Ventricular Assist Device
The aim of this single center observational study is to determine the feasibility of using non-invasive imaging methods, including smartphone photography and infrared thermography, for detecting of DLIs in LVAD patients in terms…
- Trial name
- DRIVE-ID (NCT06867887)
- Where
- Netherlands
- Volunteers
- 70 people
- Sponsor
- Erasmus Medical Center
Heart Failure, Mechanical Circulatory Support
Cell Therapy and Myocardial Recovery in Heart Failure Patients Undergoing Left Ventricular Assist Device Support
The goal of CELL-VAD Pilot trial is to investigate a personalized stem cell therapy approach for patients with advanced non-ischemic chronic heart failure (NICM) who are supported by LVAD.
- Trial name
- CELL-VAD (NCT06154044)
- Testing
- CD34+ stem cell therapy
- Where
- Slovenia
- Volunteers
- 10 people
- Sponsor
- University Medical Centre Ljubljana
Cardiovascular Diseases, Heart Diseases
Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure
The goal of this study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3 Left Ventricular Assist System when used for the treatment of advanced, refractory, left…
- Conditions
- Cardiovascular Diseases, Heart Diseases, Heart Failure
- Trial name
- INNOVATE (NCT06310031)
- Testing
- BrioVAD System, HeartMate 3
- Where
- 47 sites in United States
- Volunteers
- 780 people
- Sponsor
- BrioHealth Solutions, Inc.
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
Advanced Heart Failure, Mechanical Circulatory Support
Palliative Care Intervention to Improve Health Related Quality of Life for Patients on Long-Term LVAD Support
Background: While left ventricular assist device (LVAD) therapy improves survival in patients with advanced heart failure (AHF), unique LVAD-related burdens may impact health-related quality of life (HRQoL).
- Conditions
- Advanced Heart Failure, Mechanical Circulatory Support, Left Ventricular Assist Device, Palliative Care
- Trial name
- PALL-VAD (NCT07445932)
- Testing
- Palliative care intervention
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- Medstar Health Research Institute
Refractory Heart Failure, Cardiovascular Diseases (CVD)
European Study of the BrioVAD Heart Pump for Advanced Heart Failure
This clinical investigation evaluates the safety and clinical performance of the BrioVAD Left Ventricular Assist System in patients with advanced, refractory left ventricular heart failure who require mechanical circulatory…
- Trial name
- BRIOLIFE (NCT07252531)
- Testing
- LVAD implantation
- Where
- 2 sites in Netherlands
- Volunteers
- 60 people
- Sponsor
- BrioHealth BV
Heart Failure
Assessment of Safety and Accuracy of the Microtech System in Patients Undergoing Left Ventricular Assist Device Implantation
The Microtech-LVAD study is designed as a prospective, single arm, multi-center early feasibility study. Approximately 15 patients will be enrolled in the study.
- Trial name
- Microtech-LVAD (NCT06682910)
- Testing
- Microtech sensor pressure
- Where
- 2 sites in United States, Israel
- Volunteers
- 15 people
- Sponsor
- Microtech Medical Technologies, Ltd
CHF - Congestive Heart Failure
A Prospective, Randomized, Blind, Controlled Multicenter Clinical Study Comparing the Effectiveness of Preventive Ventricular Arrhythmia Ablation on the Prognosis After Left Ventricular Assist Device (LVAD) Surgery.
To compare the preventive effect of preventive ventricular arrhythmia ablation on the composite events 30 days after surgery in the study population.
- Trial name
- PAVA-LVAD (NCT07589738)
- Testing
- preventive ablation group
- Where
- China
- Volunteers
- 90 people
- Sponsor
- The First Affiliated Hospital of Anhui Medical University
Coronary Artery Disease, Heart Failure
Clinical Trial of Ventiflow LP Supporting High-risk Percutaneous Coronary Intervention(PCI)
The purpose of this prospective, multicenter, randomized controlled clinical trial is to evaluate the effectiveness of the transcatheter left ventricular assist system (Ventiflow LP) in providing circulatory support to patients…
- Conditions
- Coronary Artery Disease, Heart Failure, High-risk PCI
- Trial name
- NCT06754839
- Testing
- Percutaneous left ventricular assist device(Ventiflow LP), VA-ECMO
- Volunteers
- 250 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD