Clinical trials: Ventricular Assist Device
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
End-stage Heart Failure, Cardiomyopathies
VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial
The purpose of this study is to evaluate the safety and effectiveness of VentrAssistTM LVAD in individuals who are awaiting heart transplants.
- Trial name
- NCT00483197
- Testing
- VentrAssistTM Left Ventricular Assist Device
- Where
- 29 sites in United States
- Volunteers
- 140 people
- Sponsor
- Ventracor
Heart-Assist Devices, Heart Failure
Individual Blood Pressure Optimization Based on Cerebral Autoregulation After Implantation of Continuous-flow LVAD
This study will collect retrospective and prospective clinical data regarding the Principal Investigator's patient population to allow for data analysis seeking basic trends and to prepare academic reports, including journal…
- Trial name
- NIRS (NCT03093012)
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- Baylor College of Medicine
Coagulation
Left Ventricular Assist Device (LVAD) Specialized Centers of Clinically Orientated Research (SCCOR) Coagulation - Acute Intrinsic Pathway Antagonist (IPA)
The purpose of this study is to determine if post-operative administration of intrinsic pathway antagonist (TTP889) in patients on Left Ventricular Assist Device (LVAD) support will result in a 50% reduction of thrombin…
- Trial name
- NCT00909298
- Testing
- TTP889
- Where
- 3 sites in United States
- Volunteers
- 2 people
- Sponsor
- vTv Therapeutics
Chronic Heart Failure, Heart Transplant Recipient
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
The goal of this study is to create a digital platform for managing patients with chronic heart failure, those with long-term ventricular assistance, or heart transplant recipients.
- Conditions
- Chronic Heart Failure, Heart Transplant Recipient, Left Ventricular Assist Device
- Trial name
- RETENTION (NCT07008729)
- Testing
- Heart monitoring tools (data revision), Control (Standard treatment)
- Where
- 6 sites in Germany, Greece and 2 more
- Volunteers
- 390 people
- Sponsor
- Puerta de Hierro University Hospital
Congestive Heart Failure
The Epidemiology of Bleeding and Clotting in Patients Undergoing Heart Transplantation, Coronary Artery Bypass Graft Surgery,or Implantation of Left Ventricular Assist Devices
The purpose of this study is to obtain data or information on how blood clotting factors are activated during open heart surgery.
- Trial name
- NCT01481012
- Where
- 13 sites in United States
- Volunteers
- 94 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
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
Chronic Heart Failure
A Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)
This is a prospective, randomized, controlled, unblinded, multi-center evaluation of safety and efficacy in patients implanted with a HeartWare® HVAD who receive improved blood pressure management.
- Trial name
- DT2 (NCT01966458)
- Testing
- HeartWare® VAS (HVAD), Control LVAD
- Where
- 47 sites in United States
- Volunteers
- 494 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Pulmonary Arterial Hypertension
Nitric Oxide, GeNO Nitrosyl Delivery System
The primary aim of the study is to evaluate the safety, tolerability and device performance of the GeNO nitrosyl delivery system during RHC.
- Trial name
- NCT01165047
- Testing
- Nitric Oxide
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Wake Forest University Health Sciences
Heart Failure
Right Ventricular (RV) Pacing in Early Post-operative Continuous Flow Left Ventricular Assist Device (LVAD)
Continuous right ventricular (RV) pacing demonstrates harm in patients with normal left ventricular (LV) function as well as in patients with cardiomyopathy and clinical heart failure.
- Trial name
- NCT01446796
- Testing
- Implantable Cardioverter-Defibrillator (subject's pre-existing ICD)
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Duke University
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
Bleeding, Clot Blood
Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device
Heart failure is a world epidemic. LVADs are increasingly used as they have demonstrated improved survival rates compared to optimal medical management.
- Trial name
- NCT06655376
- Testing
- Aspirin, Warfarin
- Where
- 3 sites in United States
- Volunteers
- 128 people
- Sponsor
- Columbia University
Gastrointestinal Bleeding, Complication of Internal Device
Occult Gastrointestinal Bleeding in Non-pulsatile Left Ventricular Assist Device(VAD)Patients
The purpose of this study is to estimate the proportion of Ventricular Assist Device (VAD) patients with abnormal gastrointestinal bleeding as assessed by HemoQuant fecal occult blood test.
- Trial name
- NCT01415869
- Where
- 2 sites in United States
- Volunteers
- 38 people
- Sponsor
- Mayo Clinic
Heart Failure
Sacubitril/Valsartan in Left Ventricular Assist Device Recipients
The primary objective of this prospective randomised study is to assess the safety and tolerability of sacubitril/valsartan compared with standard of care used for treating BP in patients that have been implanted with the Heart…
- Trial name
- ENVAD-HF (NCT04103554)
- Testing
- Sacubitril-Valsartan, Standard of care
- Where
- 6 sites in Croatia, Czechia and 2 more
- Volunteers
- 60 people
- Sponsor
- University of Zagreb
Myocardial Infarction, Remodeling, Ventricular
Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP
Patients with anterior wall AMI treated by PCI will undergo, after successful revascularization of the infarct artery, measurement of the left ventricular pressure, and femoral angiogram.
- Conditions
- Myocardial Infarction, Remodeling, Ventricular, Shock, Cardiogenic
- Trial name
- UNLOAD-AMI (NCT04562272)
- Testing
- LV mechanical unloading by Impella-CP
- Where
- Czechia
- Volunteers
- 80 people
- Sponsor
- Institute for Clinical and Experimental Medicine
Atrial Fibrillation, Left Ventricular Failure
Non-invasive Blood Pressure and Cardiac Output Measurement by Using Applanation Tonometry
To evaluate and to validate accuracy, precision and trending ability of blood pressure and cardiac output measurement by applanation tonometry in cardiological patients having: atrial fibrillation severe impaired leftventricular…
- Conditions
- Atrial Fibrillation, Left Ventricular Failure, Left Ventricular Impaired Function, Aortic Valve Stenosis
- Trial name
- NCT02444104
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Shock, Cardiogenic
Clinical Outcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock
Retrospectively and prospectively enrolled patients with cardiogenic shock in domestic manifolds and investigated the current state of treatment and clinical features of cardiogenic shock in Koreans and identified the factors…
- Trial name
- SMART-RESCUE (NCT02985008)
- Where
- South Korea
- Volunteers
- 1,000 people
- Sponsor
- Jeong Hoon Yang
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 Assist Device
A Safety and Effectiveness Study of the Supira System in Patients Undergoing HRPCI - CE Study
The objective of this study is to evaluate the safety and effectiveness of utilizing the Supira System to provide hemodynamic support during HRPCI.
- Trial name
- SUPPORT CE (NCT06565039)
- Testing
- Supira System
- Sponsor
- Supira Medical