Clinical trials: LVAD, open to volunteers
Advanced Heart Failure, Left Ventricular Assist Device Implantation
GDF-15 and Early Outcomes After LVAD Implantation
This observational study aims to investigate the association between preoperative GDF-15 levels and early postoperative outcomes in patients undergoing left ventricular assist device (LVAD) implantation.
- Trial name
- LVAD-GDF15 (NCT07497308)
- Where
- Turkey (Türkiye)
- Volunteers
- 48 people
- Sponsor
- Akdeniz University
Ventricular Dysfunction, Right
dPmax for Predicting Right Ventricular Failure After Left Ventricular Assist Device Implantation
This single-center, prospective observational study aims to evaluate whether dPmax, a measure of the maximum rate of arterial pressure rise obtained through pulse contour analysis, can predict right ventricular failure after left…
- Trial name
- NCT07918690
- Testing
- Arterial Pulse Contour Analysis
- Where
- Turkey (Türkiye)
- Volunteers
- 89 people
- Sponsor
- Pınar Kırdemir
LVAD, Frailty
Human/Machine Interface: What the HeartMate 3 ® Device Tells Us About the Future
Durable left ventricular assist devices (dLVAD) have been increasingly utilized since the mid to late 1990s, with an uptick of utility starting in 2010 following expanded indications for therapy to not only include a bridge to…
- Conditions
- LVAD, Frailty, GI Bleed, Right Heart Failure
- Trial name
- NCT06039176
- Testing
- HeartMate 3 (R) left ventricular assist device
- Where
- 7 sites in United States
- Volunteers
- 150 people
- Sponsor
- International Consortium of Circulatory Assist Clinicians
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
Advanced Heart Failure, Mechanical Circulatory Support
Palliative Care Intervention to Improve Health Related Quality of Life for Patients on Long-Term LVAD Support
Background: While left ventricular assist device (LVAD) therapy improves survival in patients with advanced heart failure (AHF), unique LVAD-related burdens may impact health-related quality of life (HRQoL).
- Conditions
- Advanced Heart Failure, Mechanical Circulatory Support, Left Ventricular Assist Device, Palliative Care
- Trial name
- PALL-VAD (NCT07445932)
- Testing
- Palliative care intervention
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- Medstar Health Research Institute
End-stage Heart Failure
Long-Term Survival After LVAD Implantation in End-Stage Heart Failure
This is a prospective, observational, multi-center cohort study designed to evaluate long-term survival and clinical outcomes in patients with end-stage heart failure undergoing left ventricular assist device (LVAD) implantation.
- Trial name
- NCT07382284
- Testing
- Left Ventricular Assist Device (LVAD) implantation
- Where
- China
- Volunteers
- 300 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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
Tricuspid Regurgitation, Heart Failure NYHA Class III
Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients
The use of implantable left ventricular assist devices (LVAD) has increased over the last decade; partly because the newer continuous flow pumps feature a smaller design and better durability.
- Conditions
- Tricuspid Regurgitation, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
- Trial name
- NCT02537769
- Testing
- Left ventricular assist device (LVAD), Tricuspid Valve Repair (TVR)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Washington
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
- 70 sites in United States, Austria and 6 more
- Volunteers
- 850 people
- Sponsor
- Abbott Medical Devices
Heart Failure
3D Assessment of RV Function in Patients Undergoing LVAD Implantation
This goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during left ventricular assist device (LVAD) implantation.
- Trial name
- NCT05376254
- Where
- Canada
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Alberta
Heart Failure, Heart Failure At NYHA Stage III or IV
IPSC-CMs Combined with LVAD or CABG for the Treatment of Heart Failure
This clinical trial investigates the safety, feasibility, and therapeutic potential of a combined approach using HiCM-188 cardiomyocyte injection delivered intramyocardially alongside either LVAD implantation or CABG surgery in…
- Trial name
- NCT06866600
- Testing
- low dose CABG+iPSC-CMs, High dose CABG/LVAD+iPSC-CMs, CABG/LVAD+Saline
- Where
- China
- Volunteers
- 40 people
- Sponsor
- HELP Therapeutics Co., Ltd.
Heart Failure
CALM Study: Cardiomems Assisted Lvad Management
This prospective, open label, randomized, single-center pilot clinical trial will determine if the rate of heart failure related (HFR) hospitalizations is less in LVAD patients whose PAP is monitored with the CardioMEMS device vs…
- Trial name
- CALM (NCT07096544)
- Testing
- CardioMEMS Device
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Baylor Research Institute
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
Advanced Heart Failure, Left Ventricular Assist Devices
Trial of Low-intensity Anticoagulation to Reduce GI or Other Bleeding Complications With Equivalent Therapeutic Efficacy in HeartMate 3 LVAD Patients
The TARGET trial is a prospective, single-center, randomized, open-label, active-controlled inequality clinical trial designed to evaluate the safety and efficacy of low-intensity anticoagulation therapy (target INR 1.5-2.0)…
- Conditions
- Advanced Heart Failure, Left Ventricular Assist Devices, Anticoagulation Treatment, Bleeding Complications
- Trial name
- TARGET (NCT07081035)
- Testing
- Warfarin (low-intensity anticoagulation), Warfarin (standard anticoagulation)
- Where
- South Korea
- Volunteers
- 94 people
- Sponsor
- Asan Medical Center
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, Cardiomyopathy
Impella Reverse Remodeling in End-Stage Heart Failure
This observational study is being done to learn more about heart attack recovery in patients supported with the Impella 5.5 left ventricular assist device (LVAD) as part of their standard of care.
- Trial name
- NCT06800716
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Columbia University
Heart Failure, Gut Microbiome
Enhanced Nutritional Optimization in LVAD Trial
The goal of this clinical trial is to assess whether a peri-operative intervention with nutritional immune modulating intervention (Ensure Surgery Immunonutrition shake) has beneficial effects on the complex interplay between gut…
- Conditions
- Heart Failure, Gut Microbiome, Nutritional Deficiency
- Trial name
- ENOL (NCT05655910)
- Testing
- Ensure Surgery Immunonutrition shake
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
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
Heart Failure
Cardiac Hemodynamics During Left Ventricular Assist
The goal of this observational study is to exploratively investigate intracardiac geometry and hemodynamics in patients with ongoing HeartMate 3-therapy in the Swedish Southeast Healthcare region.
- Trial name
- FlowVAD (NCT06115096)
- Where
- Sweden
- Volunteers
- 35 people
- Sponsor
- Region Östergötland
LVAD (Left Ventricular Assist Device) Thrombosis, Heart Failure
SWITCH: Apixaban vs Vitamin K in HM3
This study is being done to learn the safety and efficacy of a new anticoagulant therapy with apixaban as compared to warfarin to prevent thrombotic events while protecting from bleeding complications in patients with advanced…
- Conditions
- LVAD (Left Ventricular Assist Device) Thrombosis, Heart Failure, Bleeding, Thrombosis; Artery
- Trial name
- NCT07471139
- Testing
- Warfarin, Apixaban
- Where
- United States
- Volunteers
- 460 people
- Sponsor
- Columbia University