Clinical trials: Ventricular Assist Device
LVAD (Left Ventricular Assist Device) Thrombosis
DOT HeartMate 3 Study
A prospective, single-center, randomized controlled trial of the feasibility and safety of apixaban in HeartMate 3 patients.
- Trial name
- NCT04974684
- Testing
- HeartMate 3, Apixaban
- Where
- Czechia
- Volunteers
- 45 people
- Sponsor
- Institute for Clinical and Experimental Medicine
Heart Failure, Left Ventricular Assist Device
Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
The worldwide use of left ventricular assist devices (LVAD), which is mechanical device to improve hemodynamic function, has improved the outcomes of severe heart failure (HF) patients leading to the continued annual increase in…
- Conditions
- Heart Failure, Left Ventricular Assist Device, Natriuretic Peptide
- Trial name
- CD-NP/LVAD (NCT03091998)
- Testing
- CD-NP
- Sponsor
- Mayo Clinic
Heart Failure, Ventricular Dysfunction
The Use of CoSeal (Sealant Agent) in Patients During Left Ventricular Assist Device Surgery
The purpose of this study is to evaluate the use of a device called CoSeal™. CoSeal™ is an FDA approved synthetic (man-made) surgical sealant which is currently used to help stop leaks in blood vessels during surgery.
- Trial name
- NCT01605019
- Testing
- CoSeal, BioGlue® Surgical Adhesive
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- The Methodist Hospital Research Institute
Heart Failure
Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplant or LVAD Placement
Research study evaluating the individual and combined effects of inhaled nitric oxide (iNO) and inhaled prostacyclin (iPGI2), on the function of the right heart after surgery for either heart transplant or for left ventricular…
- Trial name
- NCT01717209
- Testing
- Nitric Oxide, Prostacyclin
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Stanford University
Heart Failure
Interval Versus Continuous Training in LVAD Patients
Patients with a left ventricular assist device (LVAD) will be randomized to either a moderate continuous (MCT, 50-60% of VO2peak) or interval training (IT, 80-90% of VO2peak) group for 6 weeks with 3 sessions per week, lasting…
- Trial name
- TrainLVAD (NCT05121077)
- Testing
- Training
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- University Hospital, Essen
Heart Failure, Medication Compliance
Monitoring Medication Adherence in Left Ventricular Assist Device Recipients
The investigators aim to develop a novel and wireless method for monitoring medication adherence among heart failure patients with left ventricular assist devices (LVADs).
- Trial name
- NCT02388386
- Testing
- PROTEUS-SENSOR
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Scripps Translational Science Institute
Heart Failure
Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™
This observational post market study is intended to characterize hemodynamic-guided management of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional…
- Trial name
- INTELLECT 2-HF (NCT03247829)
- Testing
- Hemodynamic management using CardioMEMS HF System
- Where
- 23 sites in United States
- Volunteers
- 101 people
- Sponsor
- Abbott Medical Devices
Advanced Refractory Left Ventricular Heart Failure
MOMENTUM 3 IDE Clinical Study Protocol
The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
- Trial name
- HM3™ (NCT02224755)
- Testing
- HeartMate 3 LVAS, HeartMate II LVAS
- Where
- 69 sites in United States
- Volunteers
- 1,028 people
- Sponsor
- Abbott Medical Devices
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
- Volunteers
- 460 people
- Sponsor
- Columbia University
Heart Failure
Activity at Pulse Pressure Above an Individual Threshold in Patients With LVAD
Pilot study in patients with continuous flow left ventricular assist device (cfLVAD) to proof the feasibility of a specific individual training at home aimed to increase pulse pressure above a predefined threshold which might…
- Trial name
- NCT02304965
- Testing
- Daily physical activity
- Where
- Germany
- Volunteers
- 7 people
- Sponsor
- Hannover Medical School
Stage D Heart Failure
Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study
The purpose of the study is to evaluate how well tolerated and effective an angiotensin receptor-neprilysin inhibitor (sacubitril-valsartan) is in patients with contemporary durable continuous flow left ventricular assist device…
- Trial name
- SEAL-IT (NCT04191681)
- Testing
- Sacubitril-Valsartan, Usual care (standard-of-care) arm
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- The Cleveland Clinic
Coronary Artery Bypass Grafting, Left Ventricular Dysfonction
Preoperative Levosimendan in CABG Patients With Poor LV Function
The investigators want to test the hypothesis that an infusion of levosimendan started prior to CABG surgery can reduce incidence and severity of low cardiac output syndrome in patients with poor LV function (EF 40% or less).
- Trial name
- LICORN (NCT02184819)
- Testing
- levosimendan
- Where
- France
- Volunteers
- 335 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Acute Kidney Injury, Heart Failure
Effectiveness of NephroCheckTM Test to Predict Acute Kidney Injury Following Advanced Cardiac Replacement Therapies
The purpose of this study is to test how well the NephroCheckTM Test, a noninvasive laboratory test performed on urine, predicts loss of kidney function in patients that have had a heart transplant or a Left Ventricular Assist…
- Trial name
- NCT02827448
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Baylor Research Institute
Heart Failure
Stem Cell Therapy in Patients With Severe Heart Failure & Undergoing Left Ventricular Assist Device Placement
The purpose of this study is to determine if the delivery of cells just after implantation of left ventricular assist device will help to improve the pumping function of your heart and minimize heart enlargement in the future.
- Trial name
- ASSURANCE (NCT00869024)
- Testing
- Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Minnesota
Heart Failure, Cardiovascular Diseases
Novel INXN-4001 Triple Effector Plasmid in Heart Failure
To evaluate the safety of retrograde coronary sinus infusion (RCSI) of a novel triple-effector plasmid (INXN-4001) in outpatient LVAD recipients as assessed by incidence of all study intervention-related adverse events occurring…
- Conditions
- Heart Failure, Cardiovascular Diseases, Heart-Assist Device
- Trial name
- NCT03409627
- Testing
- INXN-4001
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Triple-Gene, LLC
Heart Failure, Dilated Cardiomyopathy
Harefield Recovery Protocol Study for Patients With Refractory Chronic Heart Failure
The purpose of this study is to evaluate whether patients with chronic heart failure not due to coronary artery disease who require use of a left ventricular assist device (LVAD) for refractory heart failure can recover…
- Trial name
- HARPS (NCT00585546)
- Testing
- clenbuterol
- Where
- 7 sites in United States
- Volunteers
- 18 people
- Sponsor
- Francis D. Pagani
Infective Endocarditis, Infection Related to Ventricular Assist Device
Retrospective Analysis of Nephrotoxicity During Daptomycin Versus Vancomycin Treatments in High Risk Patients
Acute kidney injury (AKI) is a frequent complication that occurs in 15 to 25% of patients after vascular surgery, and up to 40% of patients after cardiac surgery.
- Conditions
- Infective Endocarditis, Infection Related to Ventricular Assist Device, Infection Related to Vascular Prothesis, Surgical Site Infection
- Trial name
- DVN (NCT03961503)
- Testing
- Daptomycin (DAP) treatment, Vancomycin (VAN) treatment
- Where
- France
- Volunteers
- 72 people
- Sponsor
- University Hospital, Montpellier
Ischemic Heart Disease, Non-ischemic Cardiomyopathy
Serial Infusions of Allogeneic Mesenchymal Stem Cells in Cardiomyopathy Patients With Left Ventricular Assist Device
A study to assess the safety and preliminary efficacy of serial intravenous dose of Allogeneic Mesenchymal Bone Marrow Cells in subjects with heart failure and implanted left ventricular assist devices.
- Trial name
- STEM-VAD (NCT03925324)
- Testing
- Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Medstar Health Research Institute
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