Clinical trials: Left Ventricular Assist Device
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
Effects of Increased CF-LVAD Pump Speed During Sustained Submaximal Exercise
This randomized trial has been designed to study if it is possible to enhance work capacity during submaximal efforts in heart failure patients supported with continuous-flow left ventricular assist devices (CF-LVAD).
- Trial name
- NCT02335684
- Testing
- CF-LVAD pump speed baseline., CF-LVAD pump speed increased.
- Where
- Denmark
- Volunteers
- 31 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Heart Failure at NYHA Stage III or IV, Non Responders to Resynchronization
LVAD in Non Cardiac Transplant Candidates and Non Responders to Resynchronization
The prognosis for heart failure patients is bleak for the advanced stages of the disease, with a reported 6-month mortality rate of almost 50% in patients treated with chronic inotropic therapy.
- Conditions
- Heart Failure at NYHA Stage III or IV, Non Responders to Resynchronization, Non Candidates for Transplantation
- Trial name
- CHECKMATE (NCT01126944)
- Testing
- heart mate II
- Where
- 4 sites in France, Germany
- Sponsor
- Rennes University Hospital
Coagulation
Left Ventricular Assist Device (LVAD) Specialized Centers of Clinically Orientated Research (SCCOR) Coagulation - Acute Intrinsic Pathway Antagonist (IPA)
The purpose of this study is to determine if post-operative administration of intrinsic pathway antagonist (TTP889) in patients on Left Ventricular Assist Device (LVAD) support will result in a 50% reduction of thrombin…
- Trial name
- NCT00909298
- Testing
- TTP889
- Where
- 3 sites in United States
- Volunteers
- 2 people
- Sponsor
- vTv Therapeutics
Heart Failure, Systolic, Left Ventricular Assist Device
STandardized Ultra-conservative Or Physician-directed ICD Programming for Continuous Flow LVAD Support
This study will evaluate the utilization of an ultra-conservative programming strategy to reduce shocks for ventricular arrhythmias (VA) among patients with heart failure, an implantable cardioverter-defibrillator (ICD) and…
- Conditions
- Heart Failure, Systolic, Left Ventricular Assist Device, ICD
- Trial name
- NCT04264182
- Testing
- ICD programming
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- The Cleveland Clinic
Heart Failure.
Optimizing Continuous-flow Left Ventricular Assist Device Settings and Identification of Pump Malfunction - A Comparative Study of Echocardiography and Invasive Hemodynamics
The purpose of the trial is to identify factors which can be used as guidance when optimizing continuous-flow left ventricular assist device (CF-LVAD) settings.
- Trial name
- NCT01851889
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
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
Right Ventricular (RV) Pacing in Early Post-operative Continuous Flow Left Ventricular Assist Device (LVAD)
Continuous right ventricular (RV) pacing demonstrates harm in patients with normal left ventricular (LV) function as well as in patients with cardiomyopathy and clinical heart failure.
- Trial name
- NCT01446796
- Testing
- Implantable Cardioverter-Defibrillator (subject's pre-existing ICD)
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Duke University
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, Left Ventricular Assist Device
Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
The worldwide use of left ventricular assist devices (LVAD), which is mechanical device to improve hemodynamic function, has improved the outcomes of severe heart failure (HF) patients leading to the continued annual increase in…
- Conditions
- Heart Failure, Left Ventricular Assist Device, Natriuretic Peptide
- Trial name
- CD-NP/LVAD (NCT03091998)
- Testing
- CD-NP
- Sponsor
- Mayo Clinic
Right Heart Failure
Serial Multiparametric Evaluation of Right Ventricular Function After Left Ventricular Assist Device Implantation
The primary purpose of this study is to investigate the evolution of Right Ventricular (RV) function before and after left ventricular assist device (LVAD) implantation, using novel echocardiographic quantification of RV size and…
- Trial name
- EuroEchoVAD (NCT03552679)
- Testing
- Echocardiography
- Where
- 9 sites in Germany, Hungary and 5 more
- Volunteers
- 600 people
- Sponsor
- Erasmus Medical Center
LVAD (Left Ventricular Assist Device)
Feasibility and Clinical Utility of Ambulatory Ultraslow Deflation Sphygmomanometers in LVAD Recipients - easiSLOW-LVAD Pilot
Prospective, single-arm feasibility study will evaluate the use of an ultraslow deflation automated sphygmomanometer (Terumo Elemano 2) for home BP monitoring in patients with continuous-flow LVADs.
- Trial name
- easiSLOW-LVAD (NCT07633561)
- Testing
- Ultraslow deflation cuff
- Volunteers
- 50 people
- Sponsor
- University of Florida
End-stage Heart Failure, Cardiomyopathies
VentrAssistTM LVAD for the Treatment of Advanced Heart Failure - Destination Therapy
The purpose of this study is to evaluate the safety and effectiveness of LVADs in providing long-term circulatory support for patients who have chronic stage D heart failure and are ineligible for a heart transplant.
- Trial name
- NCT00490321
- Testing
- VentrAssistTM Left Ventricular Assist Device
- Where
- 27 sites in United States
- Volunteers
- 225 people
- Sponsor
- Ventracor
Kinesiophobia (Fear of Movement)
Kinesiophobia in Patients With Implanted Left Ventricular Assist Devices
The goal of this prospective and cross-sectional observational study is to learn if the presence and changes in kinesiofobia (fear of movement) affect functional capacity levels in heart failure patients who are transplant…
- Trial name
- NCT07394621
- Testing
- Physical Activity Recommandations
- Where
- Turkey (Türkiye)
- Volunteers
- 37 people
- Sponsor
- Marmara University
Heart Failure, Left Sided, Anemia, Iron Deficiency
ORal IrON Supplementation With Ferric Maltol in Patients With Heart Failure Carrying Left Ventricular Assist Devices
This is a open-label, uncontrolled, monocenter, phase IV study. The aim of this study is to detect AEs or SAEs with a relative frequency of at least 11.5% in LVAD patients with iron deficiency anemia treated with oral ferric…
- Trial name
- ORION-LVAD-1 (NCT03774615)
- Testing
- Ferric maltol 30 mg (Feraccru®)
- Where
- Germany
- Volunteers
- 11 people
- Sponsor
- Hannover Medical School
Chronic Heart Failure, Patients That Have Received a Left Ventricular Assist Device
Investigation of the Safety and Feasibility of AAV1/SERCA2a Gene Transfer in Patients With Chronic Heart Failure
The aim of the study is to determine the safety and feasibility of giving an adeno-associated viral vector expressing the sarcoplasmic reticulum calcium ATPase (SERCA2a), driven by the CMV promoter (AAV1-CMV-SERCA2a), to heart…
- Trial name
- SERCA-LVAD (NCT00534703)
- Testing
- AAV1/SERCA2a
- Where
- 2 sites in United Kingdom
- Volunteers
- 5 people
- Sponsor
- Imperial College London
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
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
Heart Failure
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
This study is a prospective, multi-center, randomized, double-blind placebo-controlled study of subjects receiving the HM II LVAD as per the current FDA approved indications for use.
- Trial name
- PREVENT II (NCT02836652)
- Testing
- HeartMate II (HMII), Warfarin, acetylsalicylic acid (ASA) therapy
- Where
- 35 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Cardiac Rehab for Advanced Heart Failure-LVAD Candidates
This study is a pilot study evaluating the feasibility and early efficacy of cardiac rehabilitation to improve frailty and symptoms in patients with advanced heart failure (NYHA class III-IV), who are being considered for LVAD…
- Trial name
- NCT03132441
- Testing
- Strength Training for Frailty
- Where
- United States
- Sponsor
- Mayo Clinic