Clinical trials: LVAD
Heart Failure, Mitral Regurgitation
Transcatheter Mitral Valve Repair as Bridge Therapy to Heart Transplantation
The aim of this study is to report medium-term outcomes after the use of transcatheter mitral valve repair (TMVR) with MitraClip as a bridge therapy to heart transplantation (HTx) in patients with mitral regurgitation (MR) and…
- Conditions
- Heart Failure, Mitral Regurgitation, End-stage Heart Failure
- Trial name
- MitraBridge (NCT04293575)
- Testing
- MitraClip
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Scientific Institute San Raffaele
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
Heart Failure
The ARIES HeartMate 3 Pump IDE Study
Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus…
- Trial name
- NCT04069156
- Testing
- LVAD Implant, Aspirin 100mg
- Where
- 51 sites in United States, Australia and 7 more
- Volunteers
- 628 people
- Sponsor
- Abbott Medical Devices
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
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
Left Ventricular Insufficiency
Safety Study of Chimeric Natriuretic Peptide(CD-NP) in Stable LVAD Patients
The most promising chimeric natriuretic peptide designed and studied by our group has been CD-NP which has anti-fibrotic and cardioprotective properties in vivo, vitro and in normal volunteers and human heart failure patients.
- Trial name
- NCT01750905
- Testing
- CD-NP
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Mayo Clinic
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
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
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
Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS
Specific Aims The aims of this trial are to evaluate the safety and effectiveness of the DuraHeart™ LVAS in patients with advanced heart failure who require LVAS support as a bridge to cardiac transplantation.
- Trial name
- NCT00710567
- Testing
- DuraHeart Left Ventricular Assist System (LVAS)
- Where
- 26 sites in United States, Canada
- Volunteers
- 66 people
- Sponsor
- Terumo Heart Inc.
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
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