Clinical trials: Ventricular Assist Device
Cardiogenic Shock, End-stage Heart Failure
ECLS Versus IMPELLA™ as Bridge to LVAD (ECI-BLAD)
In this retrospective observational multicenter study the authors tested the hypothesis that the use of IMPELLA™ pump as bridge to bridge, by giving the opportunity of active rehabilitation, should improve patient's outcomes…
- Trial name
- ECI-BLAD (NCT04480151)
- Testing
- standard of care
- Where
- 5 sites in France
- Volunteers
- 92 people
- Sponsor
- University Hospital, Bordeaux
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, Congestive, Ventricular Dysfunction
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as a bridge to cardiac transplantation in end-stage heart failure patients who are listed…
- Conditions
- Heart Failure, Congestive, Ventricular Dysfunction, Cardiomyopathies
- Trial name
- NCT00121472
- Testing
- Thoratec HeartMate II Left Ventricular Assist System (LVAS)
- Where
- 36 sites in United States, Canada
- Volunteers
- 194 people
- Sponsor
- Abbott Medical Devices
Chronic or Acute Advanced Heart Failure
South Of France Cardiac Assist Registry
Chronic heart failure is a common disease. It is also a serious disease with a mortality of 50% at 5 years, representing a significant cost in terms of public health expenditure.
- Trial name
- SOFCAR (NCT02877446)
- Where
- France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Montpellier
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
Heart Failure
Cardiac Hemodynamics During Left Ventricular Assist
The goal of this observational study is to exploratively investigate intracardiac geometry and hemodynamics in patients with ongoing HeartMate 3-therapy in the Swedish Southeast Healthcare region.
- Trial name
- FlowVAD (NCT06115096)
- Where
- Sweden
- Volunteers
- 35 people
- Sponsor
- Region Östergötland
Advanced Refractory Left Ventricular Heart Failure
HeartMate 3™ CE Mark Clinical Investigation Plan
The purpose of this clinical investigation is to evaluate the performance and safety of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) To support obtaining CE Mark for the HM3 LVAS in Europe, a multi-center clinical…
- Trial name
- HM3 CE Mark (NCT02170363)
- Testing
- Left Ventricular Assist System (LVAS)
- Where
- 10 sites in Australia, Austria and 4 more
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Congestive Heart Failure, Cardiorenal Syndrome
Nesiritide and Renal Function After the Total Artificial Heart
The prevalence of renal dysfunction after implantation of the artificial heart is high. The infusion of exogenous B-type natriuretic peptide (BNP) after implantation of the total artificial heart (TAH) improves renal function in…
- Trial name
- NCT01836809
- Testing
- nesiritide
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Virginia Commonwealth University
Heart Failure
Assessment of Safety and Accuracy of the Microtech System in Patients Undergoing Left Ventricular Assist Device Implantation
The Microtech-LVAD study is designed as a prospective, single arm, multi-center early feasibility study. Approximately 15 patients will be enrolled in the study.
- Trial name
- Microtech-LVAD (NCT06682910)
- Testing
- Microtech sensor pressure
- Where
- 2 sites in United States, Israel
- Volunteers
- 15 people
- Sponsor
- Microtech Medical Technologies, Ltd
Blood Pressure, Low
Induction Agent and Incidence of Hypotension in Heart Failure Patients Undergoing LVAD-Implantation
The induction of anesthesia is one of the most critical situations for high-risk-patients undergoing major surgery. For several reasons, it is crucial to maintain adequate blood pressure and cardiac output during this phase.
- Trial name
- INTENS (NCT04934410)
- Testing
- Etomidate, Midazolam, Sevoflurane
- Volunteers
- 50 people
- Sponsor
- Heidelberg University
End-stage Heart Failure, Cardiomyopathies
Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps
Left Ventricular Assist Device (LVAD) therapy has become a well-established treatment option for endstage heart-failure either as a bridge to transplant (BTT) or destination therapy (DT).
- Conditions
- End-stage Heart Failure, Cardiomyopathies, Mechanical Circulatory Support
- Trial name
- HM3_Snoopy (NCT04641416)
- Testing
- Routinely performed echo, ECG and hemodynamic monitoring
- Where
- Austria
- Volunteers
- 60 people
- Sponsor
- Thomas Schlöglhofer, PhD, MSc
Heart Failure
MDT-1118 Japan DT Study
To evaluate the safety and effectiveness of the MDT-1118 VAD in a patient population for destination therapy (long term support) of advanced heart failure.
- Trial name
- MDT-1118 Japan (NCT03884504)
- Testing
- Ventricular Assist Device System
- Where
- Japan
- Volunteers
- 10 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Coronary Artery Disease
Cardiovascular Systems Inc. (CSI) pVAD First in Human Study
This study will collect initial clinical data on the CSI pVAD system to inform device design and finalization.
- Trial name
- NCT05315544
- Testing
- CSI pVAD system
- Where
- Georgia
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
Left Ventricular Failure, Unspecified
Daily Life Activities in Patients Treated With Continuous-Flow Left Ventricular Assist Devices
Investigation of oxygen uptake during daily life activities in HF patients with and without LVADs.
- Trial name
- Act-VAD (NCT04732039)
- Testing
- Measurement of peak oxygen uptake
- Where
- Denmark
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
High-risk PCI
SAVE-PCI Ⅱ: NyokAssist™ Small-Bore VAD vs. ECMO in Elective High-Risk PCI
SAVE-PCI Ⅱ is a prospective, multi-center, randomized controlled trial evaluating the safety and efficacy of NyokAssist™, a small-bore percutaneous ventricular assist device (pVAD), in comparison with ECMO in patients undergoing…
- Trial name
- NCT07860671
- Testing
- NyokAssist, ECMO
- Where
- 14 sites in China
- Volunteers
- 204 people
- Sponsor
- magAssist, Inc.
Left Ventricular Dysfunction, Right Ventricular Dysfunction
Levosimendan In Patients Undergoing LVAD Implantation
According to the results from the literature, it has been shown that levosimendan usage 24-48 hours before LVAD implementation can improve short and long-term outcome in these patients regarding to the patients without…
- Conditions
- Left Ventricular Dysfunction, Right Ventricular Dysfunction, Biventricular Failure
- Trial name
- NCT03659851
- Testing
- Levosimendan 2.5 MG/ML Injectable Solution
- Where
- Croatia
- Volunteers
- 50 people
- Sponsor
- University Hospital Dubrava
Ventricular Assist Device, Advanced Heart Failure
Multi-Site Feasibility Testing of the Ventricular Assist Device Anticipatory Guidance Tool
There are a variety of educational documents available to help in a participant's decision for VAD implant, however there is little information available to potential participants to help understand areas of satisfaction and…
- Conditions
- Ventricular Assist Device, Advanced Heart Failure, Anticipatory Guidance
- Trial name
- NCT06823583
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Bryan Heart
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 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