Clinical trials: Left Ventricular Assist Device
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
Left Ventricular Assist Device, Percutaneous Lead Management
Thoratec's Reduce Driveline Trauma Through Stabilization and Exit Site Management Study
The purpose of this study is to evaluate the feasibility of a Percutaneous Lead Management Kit for HeartMate II driveline stabilization and exit site management.
- Trial name
- RESIST (NCT01485666)
- Testing
- Percutaneous Lead Management Kit
- Where
- 5 sites in United States
- Volunteers
- 50 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.
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.
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
High-risk Percutaneous Coronary Intervention
Magenta Elevate™ EFS in High-Risk PCI Patients
The Elevate™ EFS study is designed to evaluate the safety and feasibility of the Magenta Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary…
- Trial name
- NCT05727059
- Testing
- The Elevate™ System
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Magenta Medical Ltd.
Advanced Refractory Left Ventricular Heart Failure
HeartMate 3 CE Mark Study Long Term Follow-up
The purpose of this clinical investigation is to report the long term survival and incidence of adverse events in the patients who were implanted with HM3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS…
- Trial name
- HM3 CE LTFU (NCT03022461)
- Testing
- Long term follow-up
- Where
- 8 sites in Australia, Austria and 4 more
- Volunteers
- 25 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
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
High-Risk Percutaneous Coronary Intervention (High-risk PCI), Left Ventricular Assist Devices
Interventional Ventricular Assist System for PCI in CHIP Patients
In patients with complex coronary artery disease (CAD), determining the optimal revascularization strategy (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) remains a challenge.
- Trial name
- REC-CHIPMCS (NCT06373120)
- Testing
- Microaxial flow pump, VA-ECMO
- Where
- China
- Volunteers
- 262 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
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
Heart Failure
Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™
This observational post market study is intended to characterize hemodynamic-guided management of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional…
- Trial name
- INTELLECT 2-HF (NCT03247829)
- Testing
- Hemodynamic management using CardioMEMS HF System
- Where
- 23 sites in United States
- Volunteers
- 101 people
- Sponsor
- Abbott Medical Devices
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
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