Clinical trials: Left Ventricular Assist Devices Patients, open to volunteers
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) 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
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
LVAD Caregivers, LVAD (Left Ventricular Assist Device)
Compassion Strikes Back
Research has shown that LVAD patients and their caregivers typically experience increased mental health concerns and decreased quality of life following LVAD implantation and hospital discharge.
- Conditions
- LVAD Caregivers, LVAD (Left Ventricular Assist Device), Quality of Life (QOL), Self-Compassion
- Trial name
- NCT06988995
- Testing
- Information, Meeting
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Florida
Heart Failure, Arrhythmia, Ventricular
Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure
CASTLE-VT is a randomized evaluation of prophylactic ablative treatment of arrhythmogenic ventricular scar in patients referred for HTx evaluation and diagnosed with ICM.
- Conditions
- Heart Failure, Arrhythmia, Ventricular, Cardiomyopathy Ischemic, Catheter Ablation
- Trial name
- CASTLE-VT (NCT06556485)
- Testing
- Catheter ablation, Medical therapy
- Where
- Germany
- Volunteers
- 160 people
- Sponsor
- Heart and Diabetes Center North-Rhine Westfalia
Ventricular Dysfunction, Right
dPmax for Predicting Right Ventricular Failure After Left Ventricular Assist Device Implantation
This single-center, prospective observational study aims to evaluate whether dPmax, a measure of the maximum rate of arterial pressure rise obtained through pulse contour analysis, can predict right ventricular failure after left…
- Trial name
- NCT07918690
- Testing
- Arterial Pulse Contour Analysis
- Where
- Turkey (Türkiye)
- Volunteers
- 89 people
- Sponsor
- Pınar Kırdemir
Cardiogenic Shock, Heart Failure
Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock
The Elevate™ CS Clinical Feasibility Study is designed to evaluate the initial safety, effectiveness, and device performance of the Magenta Elevate™ System in patients with cardiogenic shock due to isolated or predominant left…
- Conditions
- Cardiogenic Shock, Heart Failure, Acute Myocardial Infarction (AMI)
- Trial name
- NCT07293923
- Testing
- Elevate™ System
- Where
- 8 sites in Georgia, Israel
- Volunteers
- 10 people
- Sponsor
- Magenta Medical Ltd.
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
Long-Term Survival After LVAD Implantation in End-Stage Heart Failure
This is a prospective, observational, multi-center cohort study designed to evaluate long-term survival and clinical outcomes in patients with end-stage heart failure undergoing left ventricular assist device (LVAD) implantation.
- Trial name
- NCT07382284
- Testing
- Left Ventricular Assist Device (LVAD) implantation
- Where
- China
- Volunteers
- 300 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
LVAD (Left Ventricular Assist Device) Thrombosis, Heart Failure
SWITCH: Apixaban vs Vitamin K in HM3
This study is being done to learn the safety and efficacy of a new anticoagulant therapy with apixaban as compared to warfarin to prevent thrombotic events while protecting from bleeding complications in patients with advanced…
- Conditions
- LVAD (Left Ventricular Assist Device) Thrombosis, Heart Failure, Bleeding, Thrombosis; Artery
- Trial name
- NCT07471139
- Testing
- Warfarin, Apixaban
- Where
- United States
- Volunteers
- 460 people
- Sponsor
- Columbia University
Heart Failure
A First-in-Human Study to Evaluate the Safety and Efficacy of Left Ventricular Assist Device Combined With Exosome Therapy for Patients With Heart Failure(RESTORATION)
A single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical study to evaluate the safety and tolerability of intravenous infusion of different doses of the investigational exosome preparation in heart…
- Trial name
- NCT07883317
- Testing
- Exosome Preparation
- Volunteers
- 24 people
- Sponsor
- Yining Yang
Heart Failure, Heart Diseases
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are…
- Conditions
- Heart Failure, Heart Diseases, Cardiovascular Diseases, Pulmonary Hypertension
- Trial name
- TEAM-HF (NCT06526195)
- Testing
- CardioMEMS HF System, HeartMate 3 Left Ventricular Assist System, Guideline Medical Directed Therapy
- Where
- 70 sites in United States, Austria and 6 more
- Volunteers
- 850 people
- Sponsor
- Abbott Medical Devices