Clinical trials: Ventricular Assist Device
Ventricular Assist Device, Self-management
Improved Self-management for Patients on Ventricular Assist Device (VAD)
The number of patients with end-stage heart disease requiring the implantation of ventricular assist devices (VAD) is steadily increasing.
- Conditions
- Ventricular Assist Device, Self-management, Psychological Factors
- Trial name
- SELMA (NCT04234230)
- Testing
- Prevalence Survey
- Where
- 4 sites in Germany
- Volunteers
- 393 people
- Sponsor
- University of Freiburg
End-stage Heart Failure
LVAD Versus GDMT in Ambulatory Advanced Heart Failure Patients
Heart failure is a severe disease affecting approximately 1-2% of the adult population in developed countries and around 26 million people worldwide.
- Trial name
- AMBU-VAD (NCT04768322)
- Testing
- HeartMate 3 TM Left Ventricular Assist System, Guideline Directed Medical Therapy
- Where
- 8 sites in France
- Volunteers
- 92 people
- Sponsor
- Hospices Civils de Lyon
Heart Failure, Congestive, Ventricular Dysfunction
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart failure patients who do not qualify for cardiac…
- Conditions
- Heart Failure, Congestive, Ventricular Dysfunction, Cardiomyopathies
- Trial name
- NCT00121485
- Testing
- Left Ventricular Assist System (LVAS)
- Where
- 47 sites in United States, Canada
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan
The purpose of the study is to evaluate the safety and effectiveness of the HW005 System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.
- Trial name
- HW005 (NCT02091440)
- Testing
- Implant of the HW005 Ventricular Assist System.
- Where
- 5 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
End-stage Heart Failure
Swedish Evaluation of Left Ventricular Assist Device as Permanent Treatment in End-stage Heart Failure
The study is a prospective, randomized, non-blinded, national, multi-center study. The study will consist of the assignment of eligible patients to treatment with either a HeartMate III (HM III) left ventricular assist device…
- Trial name
- SweVAD (NCT02592499)
- Testing
- HM III, OMM, optimal medical management
- Where
- 7 sites in Sweden
- Volunteers
- 74 people
- Sponsor
- Vastra Gotaland Region
Disorder of Circulatory System
Coagulopathy and SIRS During ECC in Intensive Care
This observational clinical study investigates cellular and plasmatic activation markers as well as proteins involved in coagulation and inflammation in patients being connected to different extracorporeal circulation (ECC) and…
- Trial name
- NCT02352805
- Testing
- ECLS/ECC
- Where
- Germany
- Volunteers
- 65 people
- Sponsor
- University Hospital Tuebingen
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
Self-Management App for Patients With Left-Ventricular Assist Devices
The purpose of this study is to evaluate the use of VAD Care App in an out-patient mechanical circulatory support program. The specific aim for this pilot study is to obtain preliminary efficacy data of the VAD Care App as a…
- Trial name
- NCT03049748
- Testing
- Mobile phone app (VAD Care App), Usual LVAD Care
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- University of Michigan
Cardiac Insufficiency
Effects of Left Ventricular Assist Device Implantation on the Phenotype of Blood Platelets and Leucocytes
To compare in vivo platelet and leukocyte activation and phenotype before and after Left ventricular assist device (LAVD) implantation
- Trial name
- DAV-Hémo (NCT03306017)
- Testing
- Blood sampling
- Where
- France
- Volunteers
- 4 people
- Sponsor
- University Hospital, Toulouse
Heart Failure
Comparison of Different Frailty Assessment Tools
Feasibility and Comparison of the Impact of different Frailty Assessment Tools on the Outcome of Ventricular Assist Device Implantation and Heart Transplantation in advanced heart failure patients
- Trial name
- NCT04222400
- Testing
- Frailty Assessment
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- German Heart Institute
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
Multidisciplinary Ventricular Assist Device Clinic
Current standard of care for ventricular-assist device (VAD) patients is composed of a multidisciplinary team (MDT), which is required in pre-implant and implant hospitalization care but is lacking in post-implant care.
- Trial name
- MultiVAD (NCT05388019)
- Testing
- Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires), Caregiver Self-Assessment
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Massachusetts General Hospital
Heart Failure
BeneMACS Study:HeartMate 2 (HM2)Left Ventricular Assist Device (LVAD) Survival in Non Transplant Patients is Equal/Better Than Results in Medical Literature
Study Purpose The purpose of the BeneMACS Long-Term LVAD Study is to demonstrate that survival in non transplant patients implanted with the HeartMate II LVAD as destination therapy in Belgium and the Netherlands are equivalent…
- Trial name
- BeneMACs (NCT00983190)
- Testing
- Left Ventricular Assist Device (HeartMate II)
- Where
- 2 sites in Belgium
- Volunteers
- 10 people
- Sponsor
- Abbott Medical Devices
Thrombus of Left Ventricle
Cohort of Patients With Left Ventricular Thrombus: Management and Outcomes in the Direct Oral Anticoagulants Era
The investigators' primary objective is to assess whether a difference in the occurrence of bleeding events exist between patients with LVT treated with DOACs as compared to those treated with VKAs.
- Trial name
- LV-Thrombus (NCT05028777)
- Where
- Switzerland
- Volunteers
- 550 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
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
End-stage Heart Failure, Cardiomyopathies
VentrAssistTM LVAD for the Treatment of Advanced Heart Failure - Destination Therapy
The purpose of this study is to evaluate the safety and effectiveness of LVADs in providing long-term circulatory support for patients who have chronic stage D heart failure and are ineligible for a heart transplant.
- Trial name
- NCT00490321
- Testing
- VentrAssistTM Left Ventricular Assist Device
- Where
- 27 sites in United States
- Volunteers
- 225 people
- Sponsor
- Ventracor
Heart Failure
Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices
Prospective, randomized, controlled, open label, trial of LVAD patients with 1:1 randomization to either apixaban or warfarin.
- Trial name
- DOAC LVAD (NCT04865978)
- Testing
- Apixaban, Warfarin, LVAD implant
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Palak Shah
Ventricular Dysfunction, Left
Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation
The purpose of this study is to characterize changes in the plasma proteome over time following left ventricular assist device (LVAD) implantation.
- Trial name
- NCT02428894
- Testing
- LVAD
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Colorado, Denver
Congestive Heart Failure
The Epidemiology of Ventricular Assist Device-Related Infections
Infections often occur after ventricular assist devices (VADs) are placed. These infections can be very serious. The goal of this study is to understand why these infections occur.
- Trial name
- NCT01471795
- Where
- 13 sites in United States
- Volunteers
- 150 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
LVAD (Left Ventricular Assist Device) Driveline Infection
Effect of Cardiac Resynchronization Therapy (CRT) on Left Ventricular Assist Device (LVAD) Function
Certain patients with congestive heart failure are treated both by implantation of an LVAD, as well as implantation with a biventricular pacemaker.
- Trial name
- NCT04153786
- Testing
- Temporary changes in an already-implanted medical device (biventricular pacemaker)
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of California, Davis