Clinical trials: Left Ventricular Assist Devices
Heart Failure, Cardiomyopathy
The Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in Patients Undergoing LVAD Implantation
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
- NCT01442129
- Testing
- MPC Intramyocardial injection, Control Solution
- Where
- 11 sites in United States
- Volunteers
- 30 people
- Sponsor
- Deborah Ascheim
High-Risk Percutaneous Coronary Intervention (High-risk PCI), Left Ventricular Assist Devices
Interventional Left Ventricular Assist System for PCI in CHIP Patients
Mechanical circulatory support (MCS) is a life-sustaining therapy first introduced in the 1950s. After six decades of development, it now serves as a critical bridge therapy for patients with acute cardiac events and end-stage…
- Trial name
- NCT07053618
- Testing
- Implantation of the VADLINK Percutaneous Left Ventricular Assist Device, VA-ECMO
- Where
- 15 sites in China
- Volunteers
- 286 people
- Sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTD
Advanced Heart Failure
Prospective Observation of Exercise Parameters in Advanced Heart Failure
To observe and document ventilation parameters in the advanced heart failure population, through the course of illness, which often includes cardiac resynchronization therapy (CRT), left ventricular assist device (LVAD), and…
- Trial name
- NCT01210573
- Testing
- adjustment of LVAD or pacemaker
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Cardiogenic Shock, Heart Failure
Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock
The Elevate™ CS Clinical Feasibility Study is designed to evaluate the initial safety, effectiveness, and device performance of the Magenta Elevate™ System in patients with cardiogenic shock due to isolated or predominant left…
- Conditions
- Cardiogenic Shock, Heart Failure, Acute Myocardial Infarction (AMI)
- Trial name
- NCT07293923
- Testing
- Elevate™ System
- Where
- 8 sites in Georgia, Israel
- Volunteers
- 10 people
- Sponsor
- Magenta Medical Ltd.
Heart Failure, Obesity
Laparoscopic Sleeve Gastrectomy as Bridge-to-Candidacy for Obese Left-Ventricular Assist Device Patients
In LVAD (Left-Ventricular Assist Device) patients, evidence is lacking regarding the safety and efficacy of Laparoscopic Sleeve Gastrectomy (LSG) as a means to reach a Body Mass Index (BMI) within listing criteria for heart…
- Trial name
- LSG-BTC-LVAD (NCT03008096)
- Testing
- Laparoscopic Sleeve Gastrectomy
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Philipp Angleitner
Heart Failure With Reduced Ejection Fraction
HF Patients With LVADs Being Treated With SGLT2i
The main purpose of this study is to observe outcomes of sodium-glucose co-transporter 2 inhibitors (SGLT2i) in heart failure (HF) patients with left ventricular assist devices (LVAD).
- Trial name
- NCT05278962
- Testing
- SGLT2i, No SGLT2i
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- University of Chicago
Shock, Cardiogenic
Clinical Outcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock
Retrospectively and prospectively enrolled patients with cardiogenic shock in domestic manifolds and investigated the current state of treatment and clinical features of cardiogenic shock in Koreans and identified the factors…
- Trial name
- SMART-RESCUE (NCT02985008)
- Where
- South Korea
- Volunteers
- 1,000 people
- Sponsor
- Jeong Hoon Yang
Right Ventricular Dysfunction
Hemodynamic Assessment of the Right Ventricle Using Pressure-volume Loop Catheter and Pulmonary Artery Catheter in Patients Undergoing Left Ventricular Assist Device Placement
This study will include the placement of a pressure volume (PV) loop catheter in the right atrium of patients undergoing left ventricular assist device (LVAD) placement and measure relevant PV loop data.
- Trial name
- NCT04478890
- Testing
- Hemodynamic assessment
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of Minnesota
Left Ventricular Assist Device
Blood-pressure Measuring in Patients Carrying a Left Ventricular Assist Device
To prove the novel device is able to reliably detect pulsatility in patients with CF-VADs and to analyze whether pre-programmed intrinsic pulsatility of the 3rd generation CF-VADs can also be picked up.
- Trial name
- LVAD (NCT03458988)
- Testing
- Blood-pressure measuring (Nellcor™ Adult SpO2 Sensor)
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Heart Failure
3D Assessment of RV Function in Patients Undergoing LVAD Implantation
This goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during left ventricular assist device (LVAD) implantation.
- Trial name
- NCT05376254
- Where
- Canada
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Alberta
Gastrointestinal Bleeding, Complication of Internal Device
Occult Gastrointestinal Bleeding in Non-pulsatile Left Ventricular Assist Device(VAD)Patients
The purpose of this study is to estimate the proportion of Ventricular Assist Device (VAD) patients with abnormal gastrointestinal bleeding as assessed by HemoQuant fecal occult blood test.
- Trial name
- NCT01415869
- Where
- 2 sites in United States
- Volunteers
- 38 people
- Sponsor
- Mayo Clinic
Heart Failure, Ischemic Cardiomyopathy
Left Ventricular Assist Device Combined With Allogeneic Mesenchymal Stem Cells Implantation in Patients With End-stage Heart Failure.
The aim of the study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with end-stage ischemic cardiomyopathy undergoing left ventricular assist device…
- Trial name
- NCT01759212
- Testing
- Allogeneic stem cells implantation
- Where
- Greece
- Volunteers
- 1 people
- Sponsor
- AHEPA University Hospital
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 Implant Complication
Establishment of a LVAD Destination Program in a Swiss Non Cardiac Transplant University Hospital
The goal of this study is to demonstrate the challenges and the effort to set up an artificial heart program as well as to report about the follow-up treatment and the mortality rate
- Trial name
- NCT04263012
- Testing
- collection of patient data
- Where
- Switzerland
- Volunteers
- 20 people
- Sponsor
- University Hospital, Basel, Switzerland
Hypertension, Pulmonary, Ventricular Dysfunction, Left
Confirmatory Study of IK-3001 in Japanese Subjects With Peri-/Post-op Pulmonary Hypertension Assoc. With Cardiac Surgery
Sixteen Japanese subjects (6 adults/10 children) with peri- and post-operative pulmonary hypertension associated with cardiac surgery will be evaluated at approx. 6 sites for safety and efficacy of IK-3001.
- Trial name
- NCT01959828
- Testing
- IK-3001
- Where
- 7 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Mallinckrodt
Myocardial Infarction, Percutaneous Coronary Intervention
Text Message Intervention to Improve Cardiac Rehab Participation
Cardiac rehabilitation (CR) is strongly recommended for patients with coronary heart disease. However, patient enrollment and completion of cardiac rehabilitation is low.
- Conditions
- Myocardial Infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Surgery, Heart Valve Repair or Replacement
- Trial name
- NCT03346278
- Testing
- Text Messaging Intervention
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- University of Washington
Ventricular Tachycardia
Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation
The purpose of this research study is to evaluate the safety and feasibility of the Impella 2.5 Circulatory Support System for use during mapping and ablation of ventricular tachycardia in the setting of Ventricular dysfunction.
- Trial name
- PERMIT1 (NCT01294267)
- Testing
- Circulatory Support System
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Vivek Reddy
Heart Failure, Cardiovascular Diseases
Novel INXN-4001 Triple Effector Plasmid in Heart Failure
To evaluate the safety of retrograde coronary sinus infusion (RCSI) of a novel triple-effector plasmid (INXN-4001) in outpatient LVAD recipients as assessed by incidence of all study intervention-related adverse events occurring…
- Conditions
- Heart Failure, Cardiovascular Diseases, Heart-Assist Device
- Trial name
- NCT03409627
- Testing
- INXN-4001
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Triple-Gene, LLC
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
Pulmonary Hypertension
Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
STUDY OBJECTIVES Primary objective To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD)…
- Trial name
- SOPRANO (NCT02554903)
- Testing
- Macitentan 10mg
- Where
- 50 sites in United States
- Volunteers
- 57 people
- Sponsor
- Actelion