Clinical trials: Ventricular Assist Device
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.
Cardiovascular Diseases, Heart Diseases
Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)
The Intermacs registry is a national quality improvement system designed to advance the understanding and application of mechanical circulatory support in order to improve the duration and quality of life in patients with…
- Conditions
- Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive
- Trial name
- NCT00119834
- Testing
- Mechanical Circulatory Support Device (MCSD)
- Where
- United States
- Volunteers
- 23,472 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
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
Heart Failure
Identifying and Facilitating Ventricular Recovery on Mechanical Support
Heart failure is a progressive disorder in which the weakened heart is not able to efficiently pump blood throughout the body. When the body's cells do not receive enough blood, this can result in fatigue, shortness of breath…
- Trial name
- RECOVER (NCT00687856)
- Testing
- Echocardiogram (echo)
- Where
- 5 sites in United States
- Volunteers
- 211 people
- Sponsor
- University of Pittsburgh
Heart Failure, Cardiogenic Shock
Registry for Cardiogenic Shock: Utility and Efficacy of Device Therapy
The purpose of this study is to gather information on patients who have heart failure and are eligible for one of the following two procedures: 1) mechanical support, i.e. ventricular assist device (VAD) or 2) heart transplant.
- Trial name
- RESCUE (NCT02790242)
- Where
- 7 sites in United States
- Volunteers
- 1,089 people
- Sponsor
- Columbia University
Heart Failure
Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity (VAFRACT)
After the implantation of a left ventricular assist device (LVAD), many patients continue to experience exercise intolerance. LVAD echo guided optimization (EO) determines a more favorable hemodynamic profile and could provide an…
- Trial name
- VAFRACT (NCT03937570)
- Testing
- echo-optimization
- Where
- Italy
- Volunteers
- 27 people
- Sponsor
- Universita di Verona
Chronic Heart Failure
Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure
The purpose of this study is to evaluate the safety and effectiveness of the HeartWare® LVAD System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.
- Trial name
- ADVANCE (NCT00751972)
- Testing
- HeartWare® VAS
- Where
- 35 sites in United States
- Volunteers
- 140 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
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
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
Thrombosis, Bleeding
Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device (LVAD)
Patients with severe heart failure supported by left ventricular assist device (LVAD) require adequate long-term anticoagulant therapy.
- Trial name
- NCT02872649
- Testing
- Dabigatran, Phenprocoumon
- Where
- Austria
- Volunteers
- 16 people
- Sponsor
- Daniel Zimpfer, MD
Gastrointestinal Bleeding
Safety Study of Octreotide Injection to Prevent GI Bleeding in Patients With Left Ventricular Assist Device (LVAD)
The investigators hypothesize that octreotide LAR (Long Acting Release) safely decreases GI bleeding in patients with a left ventricular assist device (LVAD).
- Trial name
- NCT01707225
- Testing
- Octreotide LAR Depot
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Virginia Commonwealth University
Systolic Heart Failure
Frailty: Prevalence and Response to Left Ventricular Assist Device Therapy in Older Heart Failure Patients
This is an observational study evaluating changes in frailty and associated impairments in older heart failure patients receiving left ventricular assist device therapy.
- Trial name
- NCT02156583
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Thomas Jefferson University
End-stage Heart Failure
Swedish Evaluation of Left Ventricular Assist Device as Permanent Treatment in End-stage Heart Failure
The study is a prospective, randomized, non-blinded, national, multi-center study. The study will consist of the assignment of eligible patients to treatment with either a HeartMate III (HM III) left ventricular assist device…
- Trial name
- SweVAD (NCT02592499)
- Testing
- HM III, OMM, optimal medical management
- Where
- 7 sites in Sweden
- Volunteers
- 74 people
- Sponsor
- Vastra Gotaland Region
Anticoagulation, Left Ventricular Assist Device
Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II Left Ventricular Assist System (LVAS) (TRACE)
The purpose of this observational study is to obtain multi-center data on HeartMate II (HMII) patients managed with reduced anticoagulation or anti-platelet regimes, and the incidence of thrombotic and bleeding adverse events…
- Trial name
- TRACE (NCT01477528)
- Where
- 18 sites in United States, Austria and 3 more
- Volunteers
- 201 people
- Sponsor
- Abbott Medical Devices
Type 2 Diabetes Mellitus, Hyperglycemia
A Study of Glycemic Control in Left Ventricular Assist
The study is being conducted to understand if the hemoglobin A1c, a measurement of control of blood sugars over a 3-month time, is valid in patients with Left Ventricular Assist Devices (LVADs) in place.
- Conditions
- Type 2 Diabetes Mellitus, Hyperglycemia, Hypoglycemia
- Trial name
- GLYCEM1C-LVAD (NCT05933161)
- Testing
- Freestyle Libre 3 Continuous Glucose Monitor (CGM)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Mayo Clinic
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
Heart Failure, Cardiomyopathies
Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device Under a Continued Access Protocol
The main purpose of this protocol is to provide a mechanism for continued access for patients that would have been enrolled into the primary cohorts of the IDE study.
- Trial name
- CAP (NCT01242891)
- Testing
- EXCOR® Pediatric Ventricular Assist Device
- Sponsor
- Berlin Heart, Inc
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, Acute Decompensated Heart Failure
Feasibility Study to Support Cardiorenal Function in Acute Decompensated Heart Failure With Diuretic Resistance
Evaluation of the safety and efficacy of the ModulHeart System in patients hospitalized with acute decompensated heart failure (ADHF) and diuretic resistance
- Conditions
- Heart Failure, Acute Decompensated Heart Failure, Cardiorenal Syndrome, Heart Failure, Congestive
- Trial name
- NCT06174623
- Testing
- ModulHeart Support
- Where
- 5 sites in Australia, Georgia
- Volunteers
- 5 people
- Sponsor
- Puzzle Medical Devices Inc.