Clinical trials: Left Ventricular Assist Devices
Heart Failure
Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device (LVAD) and Medical Management
The purpose of this study is to evaluate and compare the effectiveness of the HeartMate II (HM II) Left Ventricular Assist Device (LVAD) support versus OMM in ambulatory NYHA Class IIIB/IV heart failure patients who are not…
- Trial name
- ROADMAP (NCT01452802)
- Testing
- HM II (HeartMate II LVAD), OMM (Optimal Medical Management)
- Where
- 52 sites in United States
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Right Ventricular Failure After Implantation of Left Ventricular Assist Devices
The left ventricular assist device (LVAD) is a portable mechanical pump that helps the left side of the heart of patients with severe heart failure that are awaiting heart transplantation or are not transplant candidates.
- Trial name
- NCT01999712
- Testing
- Echocardiography
- Where
- United States
- Volunteers
- 83 people
- Sponsor
- Emory University
Heart Failure, Chronic Systolic Heart Failure
SCD for CRS in Congestive Heart Failure (CHF) (No Left Ventricular Assist Device)
The purpose of this clinical trial is to see if a new device (SCD) is safe and if it can reduce damage to the kidney enough to allow medications to work to improve heart and kidney function for use in patients that have moderate…
- Conditions
- Heart Failure, Chronic Systolic Heart Failure, Renal Failure, Cardiorenal Syndrome
- Trial name
- NCT04589065
- Testing
- Selective Cytopheretic Device
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Lenar Yessayan
End-Stage Heart Failure, Bridge-to-Transplant LVAD Placement (BTT)
Development & Testing of a Decision Aid for LVAD Placement
The goal of this project is to develop a patient-centered decision aid for decision-making about end-stage heart failure treatment.
- Conditions
- End-Stage Heart Failure, Bridge-to-Transplant LVAD Placement (BTT), Destination Therapy LVAD Placement (DT), Refusal of LVAD Placement (Decliners)
- Trial name
- VADDA (NCT02248974)
- Testing
- LVAD Decision Aid
- Where
- 7 sites in United States
- Volunteers
- 98 people
- Sponsor
- Baylor College of Medicine
Heart Failure
Sacubitril/Valsartan in Left Ventricular Assist Device Recipients
The primary objective of this prospective randomised study is to assess the safety and tolerability of sacubitril/valsartan compared with standard of care used for treating BP in patients that have been implanted with the Heart…
- Trial name
- ENVAD-HF (NCT04103554)
- Testing
- Sacubitril-Valsartan, Standard of care
- Where
- 6 sites in Croatia, Czechia and 2 more
- Volunteers
- 60 people
- Sponsor
- University of Zagreb
Ventricular Dysfunction, Left
High-dose Selenium Supplementation in Patients With Left Ventricular Assist
This planned pilot study is a monocentric, prospective, double-blind randomized and placebo controlled clinical study. The SOS-LVAD Trial can be assigned to the clinical Phase III.
- Trial name
- SOS-LVAD (NCT02530788)
- Testing
- Selenium Supplement (sodium selenite)
- Where
- Germany
- Volunteers
- 21 people
- Sponsor
- RWTH Aachen University
End-stage Heart Failure, Left Ventricular Assist Device
LVAD Index and Clinical Outcomes in Continuous-Flow LVAD Patients
This single-center, observational study evaluated the LVAD index, defined as device-estimated pump flow divided by body surface area, in adult patients supported with continuous-flow left ventricular assist devices.
- Conditions
- End-stage Heart Failure, Left Ventricular Assist Device, Mechanical Circulatory Support
- Trial name
- LVAD-INDEX (NCT07633535)
- Testing
- HeartWare Ventricular Assist Device, HeartMate 3 Left Ventricular Assist Device
- Where
- Turkey (Türkiye)
- Volunteers
- 34 people
- Sponsor
- Gaziantep City Hospital
Heart Failure, Heart Assist Device
Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients
This research study will compare two standard of care approaches for managing low sodium levels in heart failure patients with Left Ventricular Assist Device (LVAD).
- Conditions
- Heart Failure, Heart Assist Device, Hyponatremic
- Trial name
- TOLVAD (NCT05408104)
- Testing
- tolvaptan
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- University of Chicago
Heart Failure
Creation of a Digital Heart Failure Registry Using a Novel Mobile Health Platform: HUGO-HF
The investigators goal is to create a digital registry that allows for seamless integration of patient reported outcomes, electronic health record data, and pharmacy information into data collection.
- Trial name
- HUGO-HF (NCT03810638)
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- Yale University
Hemolysis Intravascular, Acute Decompensated Heart Failure
HEMolysis in a Percutaneous Axial Flow LVAD, Effects of Pentoxifylline in a Randomized Controlled Trial
Temporary mechanical circulatory support devices are increasingly used for short-term support in patients with decompensated cardiogenic shock. Recently, a new axial flow pump has become widely available with the Impella System.
- Trial name
- NCT04391231
- Testing
- Pentoxifylline Oral Product
- Where
- United States
- Sponsor
- Cedars-Sinai Medical Center
Heart Failure
Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™
This observational post market study is intended to characterize hemodynamic-guided management of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional…
- Trial name
- INTELLECT 2-HF (NCT03247829)
- Testing
- Hemodynamic management using CardioMEMS HF System
- Where
- 23 sites in United States
- Volunteers
- 101 people
- Sponsor
- Abbott Medical Devices
Advanced Refractory Left Ventricular Heart Failure
HeartMate 3 CE Mark Study Long Term Follow-up
The purpose of this clinical investigation is to report the long term survival and incidence of adverse events in the patients who were implanted with HM3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS…
- Trial name
- HM3 CE LTFU (NCT03022461)
- Testing
- Long term follow-up
- Where
- 8 sites in Australia, Austria and 4 more
- Volunteers
- 25 people
- Sponsor
- Abbott Medical Devices
Right Heart Failure, Left Ventricular Assist Device
CRD-102 for Right Heart Failure in Patients With Left Ventricular Assist Devices
This is a Phase 1b/IIa, single centre, non-randomised open-label uncontrolled study to assess safety, effect and PK of oral CRD-102 in patients with RHF associated with the presence of an LVAD.
- Trial name
- NCT03217331
- Testing
- CRD-102
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Cardiora Pty. Ltd.
Left Sided Heart Failure, Left Ventricular Assist Device
Ventricular Assist Device Anti-Factor Xa (VAD ANTIX) Monitoring Study: a Prospective Randomized Feasibility Trial
This study evaluates two different methods for monitoring a patient's anti-clotting [heparin] therapy after they receive a heart pump implant [left ventricular assist device -LVAD].
- Conditions
- Left Sided Heart Failure, Left Ventricular Assist Device, Anticoagulant Therapy, Gastro Intestinal Bleeding
- Trial name
- VAD-ANTIX (NCT03143569)
- Testing
- aPTT guided heparin management, Anti-factor Xa guided heparin management
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Washington University School of Medicine
Acute on Chronic Systolic Congestive Heart Failure, Cardiorenal Syndrome
Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD
Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic Heart Failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system…
- Trial name
- NEUTRALIZE-CRS (NCT03836482)
- Testing
- Selective Cytopheretic Device
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- SeaStar Medical
Heart Failure, Artificial Heart Device User
Noninvasive Diagnostics in Left Ventricular Assist Device Patients
Study Purpose: The purpose of this study is to evaluate the sensitivity/specificity of noninvasive diagnostic methods for the cardiac function that are based on data available from the Left Ventricular Assist Device (LVAD).
- Trial name
- NCT01981642
- Testing
- Recording of LVAD data during routine visits and daily life., Recording of daily activity using wristwatch accelerometers.
- Where
- Austria
- Volunteers
- 100 people
- Sponsor
- Medical University of Vienna
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
End Stage Heart Failure
Sildenafil for the Prevention of Right Heart Failure Following LVAD Implantation
Continuous-flow left ventricular assist devices (LVAD) move blood from the left ventricle (the largest chamber of the heart) to the aorta (the body's main artery) to help the heart better meet the needs of the body and to improve…
- Trial name
- NCT03356353
- Testing
- Sildenafil Citrate
- Where
- 4 sites in Canada
- Volunteers
- 24 people
- Sponsor
- University of Calgary
Coronary Artery Disease, Heart Failure
Clinical Trial of Ventiflow LP Supporting High-risk Percutaneous Coronary Intervention(PCI)
The purpose of this prospective, multicenter, randomized controlled clinical trial is to evaluate the effectiveness of the transcatheter left ventricular assist system (Ventiflow LP) in providing circulatory support to patients…
- Conditions
- Coronary Artery Disease, Heart Failure, High-risk PCI
- Trial name
- NCT06754839
- Testing
- Percutaneous left ventricular assist device(Ventiflow LP), VA-ECMO
- Volunteers
- 250 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
LVAD (Left Ventricular Assist Device) Thrombosis, LVAD
STudy of Aspirin Removal in Patients Supported by the Fully Magnetically Levitated CH-VAD Pump
This multi-center, prospective, randomized, double-blinded, placebo-controlled study aims to investigate whether withdrawal of aspirin from the antithrombotic regimen in patients supported with the CH-VAD pump is non-inferior to…
- Conditions
- LVAD (Left Ventricular Assist Device) Thrombosis, LVAD, LVAD (Left Ventricular Assist Device), LVAD-related GI Bleed
- Trial name
- STAR (NCT07644247)
- Testing
- Warfarin (INR 2-3) with aspirin
- Volunteers
- 370 people
- Sponsor
- China National Center for Cardiovascular Diseases