Clinical trials: Left Ventricular Assist Devices
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
Interval Versus Continuous Training in LVAD Patients
Patients with a left ventricular assist device (LVAD) will be randomized to either a moderate continuous (MCT, 50-60% of VO2peak) or interval training (IT, 80-90% of VO2peak) group for 6 weeks with 3 sessions per week, lasting…
- Trial name
- TrainLVAD (NCT05121077)
- Testing
- Training
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- University Hospital, Essen
Heart Failure With Reduced Ejection Fraction, Left Ventricular Assist Device
Influence of Right Ventricular Function on Changes in Exercise Capacity After LVAD
This is an exploratory project with the purpose to describe the responses of the right ventricle (RV) and gas exchange during exercise in patients scheduled to undergo left ventricular assist device (LVAD) implant.
- Trial name
- NCT05916612
- Sponsor
- Henry Ford Health System
Stage D Heart Failure
Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study
The purpose of the study is to evaluate how well tolerated and effective an angiotensin receptor-neprilysin inhibitor (sacubitril-valsartan) is in patients with contemporary durable continuous flow left ventricular assist device…
- Trial name
- SEAL-IT (NCT04191681)
- Testing
- Sacubitril-Valsartan, Usual care (standard-of-care) arm
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- The Cleveland Clinic
Chronic Myocardial Ischemia
Bone Marrow-derived Mesenchymal Stem Cells (MSC) Administration in Weaning From Left Ventricular Assist Device
Left Ventricular Assist Devices are commonly used to assist failing hearts as a bridge to transplantation or for long-term support.
- Trial name
- MESAD (NCT02460770)
- Testing
- Autologous mesenchymal stem cells
- Where
- France
- Sponsor
- University Hospital, Toulouse
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
Home-Based Exercise Program Using Mobile Technology After Left Ventricular Assist Device Implantation
The goal of this clinical trial is to evaluate the effects of a home-based exercise program using mobile technology on physical activity and capacity, frailty and muscle mass, and quality of life in patients with a newly…
- Trial name
- MOVE-LVAD II (NCT06291922)
- Testing
- Exercise Intervention, Usual Care
- Where
- 4 sites in United States
- Volunteers
- 100 people
- Sponsor
- University of Pennsylvania
Heart Failure, LVAD
The Left Ventricular Assist Device (LVAD) Off or On Pump Implantation Study
The purpose of this study is to compare adverse events after off-pump LVAD surgery or on-pump LVAD surgery.
- Trial name
- LVAD-ON-OFF (NCT04219618)
- Testing
- Off-Pump, On-Pump
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- The University of Texas Health Science Center, Houston
Shock, Cardiogenic, Myocardial Infarction
Efficacy Study of LV Assist Device to Treat Patients With Cardiogenic Shock (ISAR-SHOCK)
The purpose of this study is to evaluate the efficacy and safety of a left ventricular assist device in comparison to a standard treatment with an intraaortic balloon pump (IABP) in patients with cardiogenic shock due to left…
- Trial name
- NCT00417378
- Testing
- Left Ventricular Assist Device Impella LP 2.5, Intraaortic Balloon Pump
- Where
- 2 sites in Germany
- Volunteers
- 26 people
- Sponsor
- Deutsches Herzzentrum Muenchen
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.
Heart Failure
Influence of Individualized Training on Cardiopulmonary Exercise Capacity in LVAD Patients
The aim of this study is to examine the influence of an individualized, spiroergometry- guided training on cardiopulmonary fitness in patients with a left ventricular assist device (LVAD).
- Trial name
- NCT03984162
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Heart and Diabetes Center North-Rhine Westfalia
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
Advanced Heart Failure
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea
The Korea HM3 PMS is a prospective, single arm, open-label, multi-center, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure.
- Trial name
- NCT04915924
- Testing
- HeartMate 3™ left ventricular assist system (HM3 LVAS)
- Where
- 22 sites in South Korea
- Volunteers
- 358 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Massage Therapy for Self-efficacy in LVAD Recipients
This pilot study evaluates the role of massage therapy to improve self-efficacy in patients with advanced heart failure who have recently received a left-ventricular assist device.
- Trial name
- NCT04018508
- Testing
- Massage
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Medstar Health Research Institute
Heart Failure, Heart Diseases
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are…
- Conditions
- Heart Failure, Heart Diseases, Cardiovascular Diseases, Pulmonary Hypertension
- Trial name
- TEAM-HF (NCT06526195)
- Testing
- CardioMEMS HF System, HeartMate 3 Left Ventricular Assist System, Guideline Medical Directed Therapy
- Where
- 68 sites in United States, Austria and 6 more
- Volunteers
- 850 people
- Sponsor
- Abbott Medical Devices
Healthcare-Associated Infections
Understanding and Addressing Variations in HAIs After Durable Ventricular Assist Device Therapy
Substantial center variability exists in healthcare-associated infection (HAI) rates following durable ventricular assist device (VAD) implantation for patients with advanced heart failure.
- Trial name
- NCT03749434
- Where
- United States
- Volunteers
- 34,958 people
- Sponsor
- University of Michigan
Heart Failure
Biological Markers Predicting Exercise Capacity in CF-LVAD Patients.
Establishing the association between biological markers and exercise capacity in continuous-flow left ventricular assist device patients.
- Trial name
- NCT02303236
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
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
Heart Failure
Cardiac Resynchronization Therapy (CRT) and Left Ventricular Assist Devices (LVAD) Therapy
Cardiac resynchronization therapy (CRT) or biventricular pacing is a useful treatment for heart failure and those suffering from arrhythmias.
- Trial name
- NCT02083419
- Testing
- LVAD CRT
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Florida
Heart Failure
Role of Cytosorb in Left Ventricular Assist Device Implantation
Mechanical circulatory support, specifically implantable continuous flow left ventricular assist device (CF-LVAD) therapy has been established as a viable treatment for rapidly deteriorating patients suffering from end stage…
- Trial name
- CYCLONE-LVAD (NCT04596813)
- Testing
- CytoSorb 300 mL device
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- Imperial College London