Clinical trials: Left Ventricular Assist Devices
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
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
Left Ventricular Assist Device, Percutaneous Lead Management
Thoratec's Reduce Driveline Trauma Through Stabilization and Exit Site Management Study
The purpose of this study is to evaluate the feasibility of a Percutaneous Lead Management Kit for HeartMate II driveline stabilization and exit site management.
- Trial name
- RESIST (NCT01485666)
- Testing
- Percutaneous Lead Management Kit
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Severe Cardiac Insufficiency
Determination of Risk Factors of Ventricular Arrhythmias (VAs) After Implantation of Continuous Flow Left Ventricular Assist Device With Continuous Flow Left Ventricular Assist Device (CF-LVAD)
Determination of risk factors of ventricular arrhythmias (VAs) after implantation of continuous flow left ventricular assist device in order to characterize which patient requires ICD implantation in primary prevention.
- Trial name
- ASSIST-ICD (NCT02873169)
- Testing
- Implantable cardioverter-defibrillator
- Where
- 20 sites in France
- Volunteers
- 681 people
- Sponsor
- Rennes University Hospital
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 Rate, Chronotropic Incompetence
Pacing in Left Ventricular Assist Device Recipients
Implantation with left ventricular assist device (LVAD) in patients with end-stage heart failure (HF) leads to improvements in survival and quality of life, however, work capacity remains disappointingly low, at half of the…
- Conditions
- Heart Rate, Chronotropic Incompetence, Pacing
- Trial name
- Pace-VAD (NCT03844516)
- Testing
- Peak oxygen uptake test with pacing, Peak oxygen uptake test without pacing
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Finn Gustafsson
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
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
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
Kinesiophobia (Fear of Movement)
Kinesiophobia in Patients With Implanted Left Ventricular Assist Devices
The goal of this prospective and cross-sectional observational study is to learn if the presence and changes in kinesiofobia (fear of movement) affect functional capacity levels in heart failure patients who are transplant…
- Trial name
- NCT07394621
- Testing
- Physical Activity Recommandations
- Where
- Turkey (Türkiye)
- Volunteers
- 37 people
- Sponsor
- Marmara University
Heart Failure, Left Sided, Anemia, Iron Deficiency
ORal IrON Supplementation With Ferric Maltol in Patients With Heart Failure Carrying Left Ventricular Assist Devices
This is a open-label, uncontrolled, monocenter, phase IV study. The aim of this study is to detect AEs or SAEs with a relative frequency of at least 11.5% in LVAD patients with iron deficiency anemia treated with oral ferric…
- Trial name
- ORION-LVAD-1 (NCT03774615)
- Testing
- Ferric maltol 30 mg (Feraccru®)
- Where
- Germany
- Volunteers
- 11 people
- Sponsor
- Hannover Medical School
Angiodysplastic Bleeding
u-STOP LVAD Bleed: Utilization of Umbilical Cord Lining Stem Cells (ULSCs) To Prevent Left Ventricular Assist Device (LVAD) Associated Angiodysplastic Bleeding
This is a Phase I, single ascending dose, first in human, open-label, non-controlled, dose-escalation trial that will investigate intravenous infusions of Umbilical cord lining stem cells (UCLSCs) in Left Ventricular Assist…
- Trial name
- NCT04811261
- Testing
- Intravenous Infusion of UCLSCs
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Florida
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
Interleukin-1 Receptor Antagonist for the Treatment of Heart Failure in Patients With Left Ventricular Assist Devices
Heart failure remains a major cause of morbidity and mortality. Many patients with heart failure receive support from a left ventricular assist device (LVAD) at some point in the course of their disease.
- Trial name
- NCT02547766
- Testing
- Anakinra
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Utah
Driveline Infection
Incidence and Management of Driveline Infection in Patients with CH-VAD
The goal of this observational study is to learn about the incidence of the Driveline Infection of a novel full-magnetically levitated left ventricular assist device with a new design of driveline.
- Trial name
- NCT06878456
- Where
- China
- Volunteers
- 181 people
- Sponsor
- China National Center for Cardiovascular Diseases
Advanced Heart Failure, Left Ventricular Assist Devices
Trial of Low-intensity Anticoagulation to Reduce GI or Other Bleeding Complications With Equivalent Therapeutic Efficacy in HeartMate 3 LVAD Patients
The TARGET trial is a prospective, single-center, randomized, open-label, active-controlled inequality clinical trial designed to evaluate the safety and efficacy of low-intensity anticoagulation therapy (target INR 1.5-2.0)…
- Conditions
- Advanced Heart Failure, Left Ventricular Assist Devices, Anticoagulation Treatment, Bleeding Complications
- Trial name
- TARGET (NCT07081035)
- Testing
- Warfarin (low-intensity anticoagulation), Warfarin (standard anticoagulation)
- Where
- South Korea
- Volunteers
- 94 people
- Sponsor
- Asan Medical Center
Left Ventricular Assist Device, Heart Failure
Pulse Wave Analysis in Advanced Heart Failure
A comparison of pulse wave characteristics, as measured by peripheral tonometry, in pre and post Left Ventricular Assist Device (LVAD) patients.
- Conditions
- Left Ventricular Assist Device, Heart Failure, Intra-aortic Balloon Pump, LVAD Clot
- Trial name
- PWA-HF (NCT01642927)
- Where
- United States
- Sponsor
- University of Minnesota
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
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
Impact of Cardiac Resynchronization Therapy on Right Ventricular Function in Left Ventricular Assist Device Patients
Left Ventricular Assist Devices (LVAD) are mechanical heart pumps that are increasingly being implanted in patients with severe heart failure which have failed medical therapy.
- Trial name
- CRT-LVAD (NCT02169076)
- Testing
- Cardiac Resynchronization Therapy
- Where
- United States
- Sponsor
- University of Louisville