Clinical trials: Left Ventricular Assist Devices Patients
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
Left Ventricular Assist Devices Patients
REVADE : Right Ventricular Function and Exercise in Left Ventricular Assist Device Patients : Echocardiographic Study
Heart failure is a public health problem, responsible for 150.000 admissions, 32.000 deaths, 1% of public health expenditure each year in France.
- Trial name
- REVADE (NCT02067455)
- Testing
- adding 2 cardiopulmonary exercise testings : peak oxygen consumption (VO2 max) and stress echocardiography
- Where
- France
- Volunteers
- 12 people
- Sponsor
- Rennes University Hospital
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
Heart Failure
Massage Therapy for Self-efficacy in LVAD Recipients
This pilot study evaluates the role of massage therapy to improve self-efficacy in patients with advanced heart failure who have recently received a left-ventricular assist device.
- Trial name
- NCT04018508
- Testing
- Massage
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Medstar Health Research Institute
Right Heart Failure, Left Ventricular Assist Device
CRD-102 for Right Heart Failure in Patients With Left Ventricular Assist Devices
This is a Phase 1b/IIa, single centre, non-randomised open-label uncontrolled study to assess safety, effect and PK of oral CRD-102 in patients with RHF associated with the presence of an LVAD.
- Trial name
- NCT03217331
- Testing
- CRD-102
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Cardiora Pty. Ltd.
Heart Failure
Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device (LVAD) and Medical Management
The purpose of this study is to evaluate and compare the effectiveness of the HeartMate II (HM II) Left Ventricular Assist Device (LVAD) support versus OMM in ambulatory NYHA Class IIIB/IV heart failure patients who are not…
- Trial name
- ROADMAP (NCT01452802)
- Testing
- HM II (HeartMate II LVAD), OMM (Optimal Medical Management)
- Where
- 52 sites in United States
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Thrombosis, Bleeding
Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device (LVAD)
Patients with severe heart failure supported by left ventricular assist device (LVAD) require adequate long-term anticoagulant therapy.
- Trial name
- NCT02872649
- Testing
- Dabigatran, Phenprocoumon
- Where
- Austria
- Volunteers
- 16 people
- Sponsor
- Daniel Zimpfer, MD
Gastrointestinal Bleeding
Safety Study of Octreotide Injection to Prevent GI Bleeding in Patients With Left Ventricular Assist Device (LVAD)
The investigators hypothesize that octreotide LAR (Long Acting Release) safely decreases GI bleeding in patients with a left ventricular assist device (LVAD).
- Trial name
- NCT01707225
- Testing
- Octreotide LAR Depot
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Virginia Commonwealth University
Systolic Heart Failure
Frailty: Prevalence and Response to Left Ventricular Assist Device Therapy in Older Heart Failure Patients
This is an observational study evaluating changes in frailty and associated impairments in older heart failure patients receiving left ventricular assist device therapy.
- Trial name
- NCT02156583
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Thomas Jefferson University
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
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
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
This study is a prospective, multi-center, randomized, double-blind placebo-controlled study of subjects receiving the HM II LVAD as per the current FDA approved indications for use.
- Trial name
- PREVENT II (NCT02836652)
- Testing
- HeartMate II (HMII), Warfarin, acetylsalicylic acid (ASA) therapy
- Where
- 35 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Abbott Medical Devices
Chronic Heart Failure, Patients That Have Received a Left Ventricular Assist Device
Investigation of the Safety and Feasibility of AAV1/SERCA2a Gene Transfer in Patients With Chronic Heart Failure
The aim of the study is to determine the safety and feasibility of giving an adeno-associated viral vector expressing the sarcoplasmic reticulum calcium ATPase (SERCA2a), driven by the CMV promoter (AAV1-CMV-SERCA2a), to heart…
- Trial name
- SERCA-LVAD (NCT00534703)
- Testing
- AAV1/SERCA2a
- Where
- 2 sites in United Kingdom
- Volunteers
- 5 people
- Sponsor
- Imperial College London
Heart Failure, Gastrointestinal Bleeding
Efficacy of Omega-3 Fatty Acid Therapy in Preventing Gastrointestinal Bleeding in Patients With CF-LVAD
This study evaluates the efficacy of high-dose fish oil in decreasing rates of gastrointestinal bleeding in patients with continuous-flow left ventricular assist devices.
- Trial name
- NCT03784963
- Testing
- Omega 3 fatty acids
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Chicago
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
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, Systolic, Left Ventricular Assist Device
STandardized Ultra-conservative Or Physician-directed ICD Programming for Continuous Flow LVAD Support
This study will evaluate the utilization of an ultra-conservative programming strategy to reduce shocks for ventricular arrhythmias (VA) among patients with heart failure, an implantable cardioverter-defibrillator (ICD) and…
- Conditions
- Heart Failure, Systolic, Left Ventricular Assist Device, ICD
- Trial name
- NCT04264182
- Testing
- ICD programming
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- The Cleveland Clinic
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
Heart Failure, Cardiac Failure
Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation
The purpose of the study is to evaluate the safety and effectiveness of the ReliantHeart HeartAssist 5® VAD System in patients listed for heart transplantation and at risk of death from refractory end-stage heart failure.
- Conditions
- Heart Failure, Cardiac Failure, Congestive Heart Failure, Heart Failure, Left-sided
- Trial name
- NCT02205411
- Testing
- HeartAssist 5® VAD System, Control VAD
- Where
- 14 sites in United States
- Volunteers
- 17 people
- Sponsor
- ReliantHeart Inc.
Heart Failure, Cardiomyopathy
The Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in Patients Undergoing LVAD Implantation
The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe.
- Conditions
- Heart Failure, Cardiomyopathy, Ventricular Dysfunction
- Trial name
- NCT01442129
- Testing
- MPC Intramyocardial injection, Control Solution
- Where
- 11 sites in United States
- Volunteers
- 30 people
- Sponsor
- Deborah Ascheim