Clinical trials: LVAD
End-Stage Heart Failure, Bridge-to-Transplant LVAD Placement (BTT)
Development & Testing of a Decision Aid for LVAD Placement
The goal of this project is to develop a patient-centered decision aid for decision-making about end-stage heart failure treatment.
- Conditions
- End-Stage Heart Failure, Bridge-to-Transplant LVAD Placement (BTT), Destination Therapy LVAD Placement (DT), Refusal of LVAD Placement (Decliners)
- Trial name
- VADDA (NCT02248974)
- Testing
- LVAD Decision Aid
- Where
- 7 sites in United States
- Volunteers
- 98 people
- Sponsor
- Baylor College of Medicine
Heart Failure, Cardiovascular Disease
HeartMate 3 ELEVATE™ Registry
Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting.
- Conditions
- Heart Failure, Cardiovascular Disease, Ventricular Dysfunction
- Trial name
- ELEVATE™ (NCT02497950)
- Testing
- HeartMate 3
- Where
- 26 sites in Austria, Czechia and 9 more
- Volunteers
- 540 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Percutaneous RVAD to Preemptively Treat Right Heart Failure Post-LVAD
Prior studies have shown that left ventricular assist device (LVAD) implantation commonly results in right ventricular failure (RVF).
- Trial name
- NCT04458103
- Testing
- Percutaneous RVAD
- Where
- United States
- Volunteers
- 161 people
- Sponsor
- Massachusetts General Hospital
Heart Failure
Right Ventricular (RV) Pacing in Early Post-operative Continuous Flow Left Ventricular Assist Device (LVAD)
Continuous right ventricular (RV) pacing demonstrates harm in patients with normal left ventricular (LV) function as well as in patients with cardiomyopathy and clinical heart failure.
- Trial name
- NCT01446796
- Testing
- Implantable Cardioverter-Defibrillator (subject's pre-existing ICD)
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Duke University
Heart Failure
The ARIES HeartMate 3 Pump IDE Study
Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus…
- Trial name
- NCT04069156
- Testing
- LVAD Implant, Aspirin 100mg
- Where
- 51 sites in United States, Australia and 7 more
- Volunteers
- 628 people
- Sponsor
- Abbott Medical Devices
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
LVAD (Left Ventricular Assist Device) Driveline Infection
A Silver Lining in the VAD Sky
The investigators propose to conduct a prospective randomized trail (RCT) of a driveline management protocol. The study will be initiated at UCSF from January 1st 2022 to December 31st 2022 as a pilot to be extended to other…
- Trial name
- LVAD-SilverD (NCT05163392)
- Testing
- Silverlon, Control
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
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, 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
Left Sided Heart Failure, Left Ventricular Assist Device
Ventricular Assist Device Anti-Factor Xa (VAD ANTIX) Monitoring Study: a Prospective Randomized Feasibility Trial
This study evaluates two different methods for monitoring a patient's anti-clotting [heparin] therapy after they receive a heart pump implant [left ventricular assist device -LVAD].
- Conditions
- Left Sided Heart Failure, Left Ventricular Assist Device, Anticoagulant Therapy, Gastro Intestinal Bleeding
- Trial name
- VAD-ANTIX (NCT03143569)
- Testing
- aPTT guided heparin management, Anti-factor Xa guided heparin management
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Washington University School of Medicine
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
Pulmonary Arterial Hypertension
Nitric Oxide, GeNO Nitrosyl Delivery System
The primary aim of the study is to evaluate the safety, tolerability and device performance of the GeNO nitrosyl delivery system during RHC.
- Trial name
- NCT01165047
- Testing
- Nitric Oxide
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Wake Forest University Health Sciences
Heart Failure, Congestive
Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure
Heart failure is a condition in which the heart is unable to pump enough blood to the body's other organs. A heart transplant may be necessary for some individuals with end-stage heart failure.
- Trial name
- NCT00383630
- Testing
- Intramyocardial injection of bone marrow mononuclear cells, Intramyocardial injection of CD34+ selected bone marrow mononuclear cells, LVAD alone
- Where
- 7 sites in United States
- Volunteers
- 1 people
- Sponsor
- Columbia University
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
Heart Failure
Biventricular Versus Right Ventricular Pacing
The study is a randomized, single-blind crossover prospective study in which investigators will determine the clinical outcomes of cardiac resynchronization therapy (CRT) pacing modalities in patients with left ventricular assist…
- Trial name
- NCT06298669
- Testing
- Biventricular Pacing, Right Ventricular Pacing
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Indiana University
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
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
Heart Failure，Congestive, Heart Failure New York Heart Association Class IV
Nicotinamide Riboside in LVAD Recipients
While preliminary data show that oral nicotinamide riboside (NR) supplementation increases myocardial levels of oxidized nicotine-adenine dinucleotide (NAD+) levels in mice, there has been no direct evidence that suggests oral NR…
- Conditions
- Heart Failure，Congestive, Heart Failure New York Heart Association Class IV, Mitochondrial Alteration
- Trial name
- PilotNR-LVAD (NCT03727646)
- Testing
- Nicotinamide riboside
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of Washington
Thromboembolism, Hemolysis
Lavare Cycle in Patients Receiving HeartWare Left Ventricular Assist Device
Left ventricular assist device (LVAD) patients remain at risk for pump thrombus and thromboembolic events through multiple mechanisms.
- Conditions
- Thromboembolism, Hemolysis, Stroke
- Trial name
- NCT04199793
- Testing
- Lavare On, Lavare Off
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- Vanderbilt University Medical Center
Pulmonary Hypertension
Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
STUDY OBJECTIVES Primary objective To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD)…
- Trial name
- SOPRANO (NCT02554903)
- Testing
- Macitentan 10mg
- Where
- 50 sites in United States
- Volunteers
- 57 people
- Sponsor
- Actelion