Clinical trials: Ventricular Assist Device
Cardiogenic Shock, Heart Failure
Veno-arterial Extracorporeal Membrane Oxygenation Prior to Left Ventricular Assist Device Implantation.
Cardiogenic shock is an uncommun pathology with a high mortatily rate around 45%. Veno arterial extracorporeal membrane oxygenation (VA-ECMO) is a temporary extracorporeal assist device which restore an adequate blood flow when a…
- Conditions
- Cardiogenic Shock, Heart Failure, Extracorporeal Membrane Oxygenation, Left Ventricular Assist Device
- Trial name
- LVAD-ECMO (NCT03583970)
- Testing
- Left Ventricular Assist Device Implantation
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Central Hospital, Nancy, France
Heart Failure
Outcomes of a Novel Magnetically Levitated LVAD: a Multicenter Analysis
This multicenter, retrospective cohort study evaluates the clinical outcomes associated with a novel fully magnetically levitated left ventricular assist device (LVAD) in patients with advanced heart failure.
- Trial name
- NCT06596499
- Testing
- CH-VAD
- Where
- China
- Volunteers
- 75 people
- Sponsor
- Beijing Anzhen Hospital
Heart Failure, Hypertension
Necklace-Shaped Sensor for Non-Invasive Remote Monitoring of Vitals
This study is designed to validate the use of the CoVa Monitoring System in subjects with implanted devices.
- Trial name
- NCT02337790
- Where
- United States
- Volunteers
- 109 people
- Sponsor
- Baxter Healthcare Corporation
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.
- Conditions
- Coronary Artery Disease, High Risk Percutaneous Coronary Intervention, Interventional Cardiology, Mechanical Circulatory Support
- Trial name
- SUPPORT II (NCT07296744)
- Testing
- The Supira System, Impella
- Where
- 25 sites in United States
- Volunteers
- 358 people
- Sponsor
- Supira Medical
Advanced Heart Failure
Wearables and Artificial Intelligence in Advanced Heart Failure Care
The goal of this observational study is to evaluate whether AI-based analyses of wearable sensor data can identify early signs of deterioration leading to hospitalization in patients with advanced heart failure.
- Trial name
- WAI-HF (NCT07051356)
- Where
- Netherlands
- Volunteers
- 200 people
- Sponsor
- UMC Utrecht
Heart Failure
Use of Simulation to Improve VAD Self-management
This study will evaluate the performance of a curriculum using medical simulators to train patients with advanced heart failure and their caregivers to master the self-management of ventricular assist devices (a device implanted…
- Trial name
- SimVAD (NCT03073005)
- Testing
- Simulation-based Mastery Learning (SBML)
- Where
- United States
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Heart Failure
Data Collection During CT for Axial Flow VADs
At present, there is not accurate way to determine specific flow rates for axial flow ventricular assist devices (VADS). If a right heart cath is needed for these patients for clinical purposes, they will also undergo a cardiac…
- Trial name
- NCT00427739
- Testing
- Cardiac CT
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Subha Raman
Heart Failure, Cardiomyopathy
Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients
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
- NCT02362646
- Testing
- MPC Intramyocardial Injection, Control Solution
- Where
- 19 sites in United States, Canada
- Volunteers
- 159 people
- Sponsor
- Annetine Gelijns
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
End-stage Heart Failure, Cardiomyopathies
Evaluation of Platelet Therapy Response in Left Ventricular Assist Device Patients
The aim of this study is to evaluate the incidence of any hemocompatibility related adverse event (HRAE) after LVAD placement in patients responsive to a standard aspirin dose using point-of-care platelet inhibition monitoring…
- Conditions
- End-stage Heart Failure, Cardiomyopathies, Mechanical Circulatory Support
- Trial name
- NCT06152562
- Testing
- VerifyNow antiplatelet therapy response test
- Where
- Austria
- Volunteers
- 24 people
- Sponsor
- Medical University of Vienna
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
Thrombocytopenia
Romiplostim in Thoracic Transplantation
The investigators developed a platelet transfusion saving strategy based on thrombopoietin administration in heart or lung transplantation (HLT) patients or assist device implantation in bridge-to-transplantation (BTT) or bridge…
- Trial name
- N-PLATE (NCT03515447)
- Testing
- Non interventional study
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Nantes University Hospital
Heart Failure, Healthcare Associated Infection
Ventricular Assist Device (VAD) Infection Prevention Survey
Annually, more than 250,000 patients in the U.S. with end-stage heart failure stand to benefit from ventricular assist device (VAD) therapy.
- Conditions
- Heart Failure, Healthcare Associated Infection, Ventricular Assist Device
- Trial name
- NCT03843021
- Testing
- VAD Infection Prevention Survey
- Where
- United States
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Ventricular Assist Device
Low Psoas Index and Cardiac Assistance: No Excess Mortality at D28 Post Implantation
The frailty syndrome is important to consider in perioperative cardiac assistance. One of its components is the patient's sarcopenia. This can be assessed by measuring the size of the psoas muscle.
- Trial name
- VAD (NCT05612555)
- Where
- France
- Volunteers
- 65 people
- Sponsor
- University Hospital, Strasbourg, France
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
Advanced Heart Failure
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea
The Korea HM3 PMS is a prospective, single arm, open-label, multi-center, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure.
- Trial name
- NCT04915924
- Testing
- HeartMate 3™ left ventricular assist system (HM3 LVAS)
- Where
- 22 sites in South Korea
- Volunteers
- 358 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Exercise Training in Patients With Left Ventricular Assist Device
The objective of the study is to test whether 12 weeks of structured supervised exercise training on top of usual care improves functional capacity in patients with end-stage heart failure with continuous flow left ventricular…
- Trial name
- Ex-VAD (NCT03369938)
- Testing
- exercise training intervention
- Where
- 5 sites in Germany
- Volunteers
- 64 people
- Sponsor
- Charite University, Berlin, Germany
Advanced Heart Failure
Hong Kong and Taiwan HM3 PMS
Hong Kong and Taiwan HM3 PMS is a prospective, single arm, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure.
- Trial name
- NCT04703855
- Testing
- HeartMate 3™ left ventricular assist system (HM3 LVAS)
- Where
- 3 sites in Hong Kong, Taiwan
- Volunteers
- 3 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Cardiovascular Disease
HeartMate 3™ LIS Study
The purpose of this study is to evaluate a less invasive implantation technique of the HeartMate 3 Left Ventricular Assist System (HM 3 LVAS) in 10 patients.
- Trial name
- HM 3 LIS (NCT02475460)
- Testing
- Less Invasive Surgery (LIS), HeartMate 3™
- Where
- 3 sites in Czechia, Germany
- Volunteers
- 13 people
- Sponsor
- Abbott Medical Devices
Phosphodiesterase Inhibitor Adverse Reaction, Right-Sided Heart Failure
Phosphodiesterase-5-inhibitors for Right Heart Failure After Left Ventricular Assist Device Implantation
Refractory right heart failure is common during the postoperative period after left ventricular assist device implantation. Oral phosphodiesterase-5 inhibitors are oft initiated in order to facilitate weaning from the intravenous…
- Trial name
- PIVAD (NCT04117659)
- Testing
- withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patients
- Where
- Germany
- Volunteers
- 32 people
- Sponsor
- University Hospital, Essen