Clinical trials: Left Ventricular Assist Devices
Left Ventricular Assist Device, Prognosis
PROgnostic Value of Exercise Capacity Measured as Peak Oxygen Uptake (pVO2) in Recipients of Left Ventricular Assist Devices
Pooling of earlier VO2-studies conducted at the dept. of cardiology, Rigshospitalet, Denmark, and all LVAD centres of the World that wish to participate.
- Conditions
- Left Ventricular Assist Device, Prognosis, Advanced Heart Failure
- Trial name
- PRO-VAD (NCT04423562)
- Testing
- No intervention
- Where
- Denmark
- Volunteers
- 500 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Chronic Heart Failure
Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure
The purpose of this study is to evaluate the safety and effectiveness of the HeartWare® LVAD System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.
- Trial name
- ADVANCE (NCT00751972)
- Testing
- HeartWare® VAS
- Where
- 35 sites in United States
- Volunteers
- 140 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Chronic Heart Failure, Heart Transplant Recipient
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
The goal of this study is to create a digital platform for managing patients with chronic heart failure, those with long-term ventricular assistance, or heart transplant recipients.
- Conditions
- Chronic Heart Failure, Heart Transplant Recipient, Left Ventricular Assist Device
- Trial name
- RETENTION (NCT07008729)
- Testing
- Heart monitoring tools (data revision), Control (Standard treatment)
- Where
- 6 sites in Germany, Greece and 2 more
- Volunteers
- 390 people
- Sponsor
- Puerta de Hierro University Hospital
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
High-risk Percutaneous Coronary Intervention
Magenta Elevate™ EFS in High-Risk PCI Patients
The Elevate™ EFS study is designed to evaluate the safety and feasibility of the Magenta Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary…
- Trial name
- NCT05727059
- Testing
- The Elevate™ System
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Magenta Medical Ltd.
Heart Failure, Mechanical Circulatory Support
Cell Therapy and Myocardial Recovery in Heart Failure Patients Undergoing Left Ventricular Assist Device Support
The goal of CELL-VAD Pilot trial is to investigate a personalized stem cell therapy approach for patients with advanced non-ischemic chronic heart failure (NICM) who are supported by LVAD.
- Trial name
- CELL-VAD (NCT06154044)
- Testing
- CD34+ stem cell therapy
- Where
- Slovenia
- Volunteers
- 10 people
- Sponsor
- University Medical Centre Ljubljana
Heart Failure
Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Heart Function in People Receiving an LVAD
Left ventricular assist devices (LVADs) are one treatment option for people with congestive heart failure. This study will evaluate the safety of injecting mesenchymal precursor cells (MPCs) into the heart during LVAD…
- Trial name
- NCT00927784
- Testing
- Mesenchymal Precursor cells (RevascorTM), Cryoprotective media alone
- Where
- 17 sites in United States
- Volunteers
- 10 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Critical Illness, Heart Failure
Effects of Negative Pressure Ventilation Onto Hemodynamics and Right Ventricular Funktion in Patients After Implantation of a Left Ventricular Assist Device.
All patients undergoing an implantation of a durable left ventricular assist device and monitored by pulmonary artery catheter showing no adverse events after surgery are included in the study and ventilated for 15 minutes using…
- Conditions
- Critical Illness, Heart Failure, LVAD
- Trial name
- NPV LVAD (NCT07034599)
- Testing
- Negative pressure ventilation, positive pressure ventilation
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Karlsburg Hospital
Heart Failure, Medication Compliance
Monitoring Medication Adherence in Left Ventricular Assist Device Recipients
The investigators aim to develop a novel and wireless method for monitoring medication adherence among heart failure patients with left ventricular assist devices (LVADs).
- Trial name
- NCT02388386
- Testing
- PROTEUS-SENSOR
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Scripps Translational Science Institute
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
CHF - Congestive Heart Failure
A Prospective, Randomized, Blind, Controlled Multicenter Clinical Study Comparing the Effectiveness of Preventive Ventricular Arrhythmia Ablation on the Prognosis After Left Ventricular Assist Device (LVAD) Surgery.
To compare the preventive effect of preventive ventricular arrhythmia ablation on the composite events 30 days after surgery in the study population.
- Trial name
- PAVA-LVAD (NCT07589738)
- Testing
- preventive ablation group
- Where
- China
- Volunteers
- 90 people
- Sponsor
- The First Affiliated Hospital of Anhui Medical University
Heart Failure
Skeletal Muscle Perfusion With LVAD
Advanced heart failure (when the heart pump fails) is associated with symptoms such as shortness of breath and extreme fatigue. Some of these symptoms are simply due to failure of the pump, however abnormal regulation of blood…
- Trial name
- NCT02105831
- Testing
- Contrast ultrasound skeletal muscle perfusion imaging
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Oregon Health and Science University
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
Refractory Heart Failure, Cardiovascular Diseases (CVD)
European Study of the BrioVAD Heart Pump for Advanced Heart Failure
This clinical investigation evaluates the safety and clinical performance of the BrioVAD Left Ventricular Assist System in patients with advanced, refractory left ventricular heart failure who require mechanical circulatory…
- Trial name
- BRIOLIFE (NCT07252531)
- Testing
- LVAD implantation
- Where
- 2 sites in Netherlands
- Volunteers
- 60 people
- Sponsor
- BrioHealth BV
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
Right Heart Failure
Predictive Value of Vasodilator Challenge for Right Heart Failure After LVAD Implantation
Prospective evaluation of the predictive value for post-LVAD right ventricular failure (RHF) of pulmonary vasodilator challenge, in addition to current laboratory, echocardiographic and haemodynamic parameters.
- Trial name
- PREVV-RHF-LVAD (NCT05836233)
- Testing
- Pulmonary Vasodilators
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- San Camillo Hospital, Rome
Atrial Fibrillation, Left Ventricular Failure
Non-invasive Blood Pressure and Cardiac Output Measurement by Using Applanation Tonometry
To evaluate and to validate accuracy, precision and trending ability of blood pressure and cardiac output measurement by applanation tonometry in cardiological patients having: atrial fibrillation severe impaired leftventricular…
- Conditions
- Atrial Fibrillation, Left Ventricular Failure, Left Ventricular Impaired Function, Aortic Valve Stenosis
- Trial name
- NCT02444104
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
LVAD (Left Ventricular Assist Device) Thrombosis
DOT HeartMate 3 Study
A prospective, single-center, randomized controlled trial of the feasibility and safety of apixaban in HeartMate 3 patients.
- Trial name
- NCT04974684
- Testing
- HeartMate 3, Apixaban
- Where
- Czechia
- Volunteers
- 45 people
- Sponsor
- Institute for Clinical and Experimental Medicine
Advanced Heart Failure, Left Ventricular Assist Device Implantation
GDF-15 and Early Outcomes After LVAD Implantation
This observational study aims to investigate the association between preoperative GDF-15 levels and early postoperative outcomes in patients undergoing left ventricular assist device (LVAD) implantation.
- Trial name
- LVAD-GDF15 (NCT07497308)
- Where
- Turkey (Türkiye)
- Volunteers
- 48 people
- Sponsor
- Akdeniz University
Aortic Regurgitation, Aortic Valve Insufficiency
The JenaValve ALIGN-AR LVAD Registry
To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically…
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
- Trial name
- JENA-VAD (NCT06594705)
- Testing
- JenaValve Trilogy Heart Valve System
- Where
- 14 sites in United States
- Volunteers
- 50 people
- Sponsor
- JenaValve Technology, Inc.