Clinical trials: Left Ventricular Assist Device
Severe Cardiac Insufficiency
Determination of Risk Factors of Ventricular Arrhythmias (VAs) After Implantation of Continuous Flow Left Ventricular Assist Device With Continuous Flow Left Ventricular Assist Device (CF-LVAD)
Determination of risk factors of ventricular arrhythmias (VAs) after implantation of continuous flow left ventricular assist device in order to characterize which patient requires ICD implantation in primary prevention.
- Trial name
- ASSIST-ICD (NCT02873169)
- Testing
- Implantable cardioverter-defibrillator
- Where
- 20 sites in France
- Volunteers
- 681 people
- Sponsor
- Rennes University Hospital
Cardiac Rehabilitation, Heart Failure
Cardiac REhabilitation COhort at the Medicine Campus DaVos to invEstigate Recovery
The RECOVER study, titled Cardiac Rehabilitation Cohort at the Medicine Campus Davos for Exploration of Recovery, is a prospective, non-interventional, monocentric cohort study conducted at the Hochgebirgsklinik Davos.
- Conditions
- Cardiac Rehabilitation, Heart Failure, Cardiac Arrest (CA), ACS (Acute Coronary Syndrome)
- Trial name
- RECOVER (NCT07096973)
- Where
- Switzerland
- Volunteers
- 10,000 people
- Sponsor
- Hochgebirgsklinik Davos
Congestive Heart Failure
Baroreflex Activation Therapy in Left Ventricular Assist Device Patients Study
This study will involve LVAD patients who have already received a clinically-indicated BAT (BAROSTIM) device. After recovery from LVAD implant, we will investigate the effects of BAT in a double-blind cross-over study design.
- Trial name
- BAT-VAD (NCT06195046)
- Testing
- Baroreflex Activation Therapy (BAT)
- Sponsor
- Medical University of South Carolina
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
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
LVAD (Left Ventricular Assist Device) Driveline Infection
A Silver Lining in the VAD Sky
The investigators propose to conduct a prospective randomized trail (RCT) of a driveline management protocol. The study will be initiated at UCSF from January 1st 2022 to December 31st 2022 as a pilot to be extended to other…
- Trial name
- LVAD-SilverD (NCT05163392)
- Testing
- Silverlon, Control
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Heart Failure, Gastrointestinal Bleeding
Efficacy of Omega-3 Fatty Acid Therapy in Preventing Gastrointestinal Bleeding in Patients With CF-LVAD
This study evaluates the efficacy of high-dose fish oil in decreasing rates of gastrointestinal bleeding in patients with continuous-flow left ventricular assist devices.
- Trial name
- NCT03784963
- Testing
- Omega 3 fatty acids
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Chicago
Heart Failure
Self-Management App for Patients With Left-Ventricular Assist Devices
The purpose of this study is to evaluate the use of VAD Care App in an out-patient mechanical circulatory support program. The specific aim for this pilot study is to obtain preliminary efficacy data of the VAD Care App as a…
- Trial name
- NCT03049748
- Testing
- Mobile phone app (VAD Care App), Usual LVAD Care
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- University of Michigan
Heart Failure, Cardiac Failure
Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation
The purpose of the study is to evaluate the safety and effectiveness of the ReliantHeart HeartAssist 5® VAD System in patients listed for heart transplantation and at risk of death from refractory end-stage heart failure.
- Conditions
- Heart Failure, Cardiac Failure, Congestive Heart Failure, Heart Failure, Left-sided
- Trial name
- NCT02205411
- Testing
- HeartAssist 5® VAD System, Control VAD
- Where
- 14 sites in United States
- Volunteers
- 17 people
- Sponsor
- ReliantHeart Inc.
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
Cardiovascular Diseases, Heart Diseases
Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure
The goal of this study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3 Left Ventricular Assist System when used for the treatment of advanced, refractory, left…
- Conditions
- Cardiovascular Diseases, Heart Diseases, Heart Failure
- Trial name
- INNOVATE (NCT06310031)
- Testing
- BrioVAD System, HeartMate 3
- Where
- 47 sites in United States
- Volunteers
- 780 people
- Sponsor
- BrioHealth Solutions, Inc.
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
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
Coronary Artery Bypass Grafting, Left Ventricular Dysfonction
Preoperative Levosimendan in CABG Patients With Poor LV Function
The investigators want to test the hypothesis that an infusion of levosimendan started prior to CABG surgery can reduce incidence and severity of low cardiac output syndrome in patients with poor LV function (EF 40% or less).
- Trial name
- LICORN (NCT02184819)
- Testing
- levosimendan
- Where
- France
- Volunteers
- 335 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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.
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
Prospective Randomized Evaluation of an Ultra Conservative Approach to Implantable Defibrillator (ICD) Programming in Patients With a Left Ventricular Assist Device (LVAD).
We propose to study a strategy empirically applied for the past 6 months at a high volume LVAD center (Vanderbilt Heart and Vascular Institute).
- Trial name
- NCT01977703
- Testing
- Ultra Conservative ICD Programming, Traditional ICD Programming
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Vanderbilt University Medical Center
LVAD Caregivers, LVAD (Left Ventricular Assist Device)
Compassion Strikes Back
Research has shown that LVAD patients and their caregivers typically experience increased mental health concerns and decreased quality of life following LVAD implantation and hospital discharge.
- Conditions
- LVAD Caregivers, LVAD (Left Ventricular Assist Device), Quality of Life (QOL), Self-Compassion
- Trial name
- NCT06988995
- Testing
- Information, Meeting
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Florida
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
Heart Failure, Arrhythmia, Ventricular
Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure
CASTLE-VT is a randomized evaluation of prophylactic ablative treatment of arrhythmogenic ventricular scar in patients referred for HTx evaluation and diagnosed with ICM.
- Conditions
- Heart Failure, Arrhythmia, Ventricular, Cardiomyopathy Ischemic, Catheter Ablation
- Trial name
- CASTLE-VT (NCT06556485)
- Testing
- Catheter ablation, Medical therapy
- Where
- Germany
- Volunteers
- 160 people
- Sponsor
- Heart and Diabetes Center North-Rhine Westfalia