Clinical trials: LVAD (Left Ventricular Assist Device)
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
End-Stage Heart Failure, Cardiomyopathies
VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial
The purpose of this trial is to determine the safety and feasibility of the VentrAssist LVAD in providing circulatory support for patients who require an LVAD as a bridge to cardiac transplantation.
- Trial name
- NCT00490347
- Testing
- VentrAssist Left Ventricular Assist Device
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Ventracor
Driveline Heart-assisted Device Related Infection
Driveline Silicone Skin Interface Registry
The purpose of this observational registry is to determine the freedom from driveline (DL) infection events in subjects implanted with a HeartMate II LVAD in whom only the silicone portion of the DL is externalized resulting in a…
- Trial name
- SSI (NCT01577433)
- Where
- 15 sites in United States
- Volunteers
- 400 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Regurgitation, Aortic Valve Disease Mixed
JOURNEY LVAD: JOURNEY Left Ventricular Assist Device
The objective of this study is to assess the safety and effectiveness of the J-Valve Transfemoral Transcatheter Heart Valve System in patients on left ventricular assist device (LVAD) support with significant native aortic valve…
- Conditions
- Aortic Valve Regurgitation, Aortic Valve Disease Mixed, Aortic Insufficiency
- Trial name
- NCT07363473
- Testing
- J-Valve Transfemoral System
- Volunteers
- 50 people
- Sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Coronary Artery Disease, High-risk Percutaneous Coronary Intervention
Early Feasibility Study of the Supira System in Patients Undergoing HRPCI
The objective of this study is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.
- Conditions
- Coronary Artery Disease, High-risk Percutaneous Coronary Intervention, Interventional Cardiology
- Trial name
- NCT06087575
- Testing
- Supira System
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Supira Medical
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.
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
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
Heart Failure
BeneMACS Study:HeartMate 2 (HM2)Left Ventricular Assist Device (LVAD) Survival in Non Transplant Patients is Equal/Better Than Results in Medical Literature
Study Purpose The purpose of the BeneMACS Long-Term LVAD Study is to demonstrate that survival in non transplant patients implanted with the HeartMate II LVAD as destination therapy in Belgium and the Netherlands are equivalent…
- Trial name
- BeneMACs (NCT00983190)
- Testing
- Left Ventricular Assist Device (HeartMate II)
- Where
- 2 sites in Belgium
- Volunteers
- 10 people
- Sponsor
- Abbott Medical Devices
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
Heart Failure
Study of Anginera in Adults With a Left Ventricular Assist Device (LVAD) as Bridge to Transplant
The purpose of this study is to obtain human heart tissue after treatment with Anginera to determine its effect on a variety of things that might indicate improvement in heart function.
- Trial name
- NCT00364598
- Testing
- Anginera, a human tissue replacement therapy
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Theregen, 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, 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
Heart Failure, Cardiovascular Diseases
Novel INXN-4001 Triple Effector Plasmid in Heart Failure
To evaluate the safety of retrograde coronary sinus infusion (RCSI) of a novel triple-effector plasmid (INXN-4001) in outpatient LVAD recipients as assessed by incidence of all study intervention-related adverse events occurring…
- Conditions
- Heart Failure, Cardiovascular Diseases, Heart-Assist Device
- Trial name
- NCT03409627
- Testing
- INXN-4001
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Triple-Gene, LLC
Congestive Heart Failure
The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation
The purpose of this study is to assess the utility of nitric oxide for inhalation during left ventricular assist device (LVAD) implantation following cardiopulmonary bypass (CPB).
- Trial name
- NCT00060840
- Testing
- Nitric Oxide, Nitrogen
- Where
- 11 sites in United States, Germany and 1 more
- Volunteers
- 150 people
- Sponsor
- Mallinckrodt
Heart Failure, Cardiovascular Disease
HeartMate 3™ LIS Study
The purpose of this study is to evaluate a less invasive implantation technique of the HeartMate 3 Left Ventricular Assist System (HM 3 LVAS) in 10 patients.
- Trial name
- HM 3 LIS (NCT02475460)
- Testing
- Less Invasive Surgery (LIS), HeartMate 3™
- Where
- 3 sites in Czechia, Germany
- Volunteers
- 13 people
- Sponsor
- Abbott Medical Devices
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
Hypertension, Pulmonary, Ventricular Dysfunction, Left
Confirmatory Study of IK-3001 in Japanese Subjects With Peri-/Post-op Pulmonary Hypertension Assoc. With Cardiac Surgery
Sixteen Japanese subjects (6 adults/10 children) with peri- and post-operative pulmonary hypertension associated with cardiac surgery will be evaluated at approx. 6 sites for safety and efficacy of IK-3001.
- Trial name
- NCT01959828
- Testing
- IK-3001
- Where
- 7 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Mallinckrodt
Pulmonary Hypertension
Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
STUDY OBJECTIVES Primary objective To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD)…
- Trial name
- SOPRANO (NCT02554903)
- Testing
- Macitentan 10mg
- Where
- 50 sites in United States
- Volunteers
- 57 people
- Sponsor
- Actelion