Clinical trials: Advanced Heart Failure
Advanced Heart Failure
CorWave LVAS FIH Study
The study is a prospective, multi-center, non-randomized trial to evaluate the safety and effectiveness of the CorWave LVAS for the treatment of advanced heart failure patients.
- Trial name
- NCT06907017
- Testing
- LVAS
- Where
- 3 sites in Australia, Kazakhstan
- Volunteers
- 20 people
- Sponsor
- CorWave
Heart Failure
Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)
COMPASS-HF was a prospective, two-arm, randomized (1:1), multi-center, parallel controlled study. The purpose of the randomized study was to test the safety of an implantable hemodynamic monitor (IHM) and pressure sensor lead.
- Trial name
- NCT00643279
- Testing
- Chronicle Implantable Hemodynamic Monitor, Standard of Care
- Where
- 28 sites in United States
- Volunteers
- 277 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Chronic Heart Failure
Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure
The purpose of this study is to evaluate the safety and effectiveness of the HeartWare® LVAD System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.
- Trial name
- ADVANCE (NCT00751972)
- Testing
- HeartWare® VAS
- Where
- 35 sites in United States
- Volunteers
- 140 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Feasibility Study of the Intravascular Ventricular Assist System (iVAS)
The purpose of this feasibility study is to assess the preliminary safety and clinical performance of the intravascular ventricular assist system (iVAS).
- Trial name
- NCT02645539
- Testing
- intravascular ventricular assist system (iVAS)
- Where
- 18 sites in United States
- Volunteers
- 100 people
- Sponsor
- NuPulseCV
Heart Failure, Congestive
ACCLAIM - Advanced Chronic Heart Failure CLinical Assessment of Immune Modulation Therapy
The purpose of this study is to test the safety and efficacy of the Celacade™ system in reducing the risk of mortality and cardiovascular hospitalizations in patients with chronic systolic heart failure.
- Trial name
- NCT00111969
- Testing
- Celacade™ system
- Volunteers
- 2,016 people
- Sponsor
- Vasogen
Heart Failure, Congestive
ESSENTIAL-"The Studies of Oral Enoximone Therapy in Advanced Heart Failure"
To determine if low-dose enoximone therapy is an effective treatment for advanced chronic heart failure.
- Trial name
- NCT00051285
- Testing
- Enoximone
- Volunteers
- 1,800 people
- Sponsor
- Gilead Sciences
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
MDT-1118 Japan DT Study
To evaluate the safety and effectiveness of the MDT-1118 VAD in a patient population for destination therapy (long term support) of advanced heart failure.
- Trial name
- MDT-1118 Japan (NCT03884504)
- Testing
- Ventricular Assist Device System
- Where
- Japan
- Volunteers
- 10 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Advanced Heart Failure
Carmat Total Artificial Heart as a Bridge to Transplant in Patients With Advanced Heart Failure
The objective of this clinical investigation is to evaluate the efficacy and the safety of the Carmat Total Artificial Heart for the treatment of refractory advanced heart failure in transplant eligible patients.
- Trial name
- EFICAS (NCT04475393)
- Testing
- Carmat Total Artificial Heart, Standard therapy for heart failure
- Where
- 10 sites in France
- Volunteers
- 104 people
- Sponsor
- Carmat SAS
Advanced Refractory Left Ventricular Heart Failure
MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS
The study will be a prospective, multi-center, non-blinded, controlled study, intended to evaluate the extended use of the HM3 LVAS compared to the HMII LVAS in those patients that are ongoing at the 2-year follow-up in the…
- Trial name
- NCT03982979
- Testing
- HM3 LVAS
- Where
- United States
- Volunteers
- 295 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
Congestive Heart Failure
Relation of Non-invasively Measured Parameters to Clinical Outcomes in CHF Patients
Our aim is to assess whether changes in CO, CI and SVR as measured using the Biobeat wearable, wireless, non-invasive device during IV diuretic administration in an outpatient setting among CHF patients correlate with short-term…
- Trial name
- NCT04548024
- Testing
- Short term monitoring
- Where
- Israel
- Volunteers
- 50 people
- Sponsor
- Biobeat Technologies Ltd.
Heart Failure, Cardiomyopathy
Clinical Evaluation on Advanced Resynchronization
The aim of the study is to compare clinical benefits of the cardiac resynchronisation (CRT) achieved by the PEA optimised pacing configuration and a CRT optimised by standard clinical procedure.
- Trial name
- NCT00658203
- Testing
- New Living CHF
- Where
- 36 sites in France, Germany and 4 more
- Volunteers
- 310 people
- Sponsor
- LivaNova
Advanced Heart Failure, Heart Transplantation
TORCH-LATAM-002: Regional Pathway for Adult Heart Transplant Evaluation and Candidacy
TORCH-LATAM-002 is a pragmatic stepped-wedge cluster randomized trial evaluating an integrated regional pathway for adults with advanced heart failure who require specialized heart transplant evaluation and a documented candidacy…
- Conditions
- Advanced Heart Failure, Heart Transplantation, Acquired Heart Disease
- Trial name
- TORCH-002 (NCT07836803)
- Testing
- TORCH Adult Heart Transplant Evaluation and Candidacy Pathway
- Volunteers
- 360 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
Left Sided Heart Failure
HW006 LATERAL Thoracotomy
This is a prospective, multi-center,single-arm study that will evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD System and enrolled in the Interagency Registry for…
- Trial name
- HVAD (NCT02268942)
- Testing
- HeartWare HVAD, Thoracotomy
- Where
- 26 sites in United States, Canada
- Volunteers
- 144 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Ischemic Cardiomyopathy, Non-ischemic Cardiomyopathy
A Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure
The purpose of this trial is to assess whether MYDICAR can reduce the frequency and/or delay heart failure related hospitalizations in persons with advanced heart failure when added to their maximal and optimized therapy.
- Conditions
- Ischemic Cardiomyopathy, Non-ischemic Cardiomyopathy, Heart Failure, Cardiomyopathies
- Trial name
- CUPID-2b (NCT01643330)
- Testing
- AAV1/SERCA2a (MYDICAR)
- Where
- 54 sites in United States, Belgium and 8 more
- Volunteers
- 250 people
- Sponsor
- Celladon Corporation
Chronic Heart Failure
The HeartWare™ Ventricular Assist System as Destination Therapy of Advanced Heart Failure: the ENDURANCE Trial
The purpose of this study is to determine the safety and effectiveness of the HeartWare Ventricular Assist System in patients with chronic Stage D/ New York Heart Association (NYHA) Class IIIB/IV left ventricular failure who have…
- Trial name
- ENDURANCE (NCT01166347)
- Testing
- HeartWare® VAS, Control LVAD
- Where
- 48 sites in United States
- Volunteers
- 451 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Advanced Refractory Left Ventricular Heart Failure
MOMENTUM 3 Continued Access Protocol
The objective of the study is to continue to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the…
- Trial name
- MOMENTUM 3 CAP (NCT02892955)
- Testing
- HeartMate 3 LVAS
- Where
- 69 sites in United States
- Volunteers
- 1,685 people
- Sponsor
- Abbott Medical Devices