Clinical trials: Advanced Refractory Left Ventricular 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
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
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
Advanced Refractory Left Ventricular Heart Failure
HeartMate 3™ CE Mark Clinical Investigation Plan
The purpose of this clinical investigation is to evaluate the performance and safety of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) To support obtaining CE Mark for the HM3 LVAS in Europe, a multi-center clinical…
- Trial name
- HM3 CE Mark (NCT02170363)
- Testing
- Left Ventricular Assist System (LVAS)
- Where
- 10 sites in Australia, Austria and 4 more
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Refractory Heart Failure
Corheart 6 LVAS Study
The primary objective of this study is to evaluate the safety and effectiveness of the Corheart 6 LVAS when used for the treatment of advanced left ventricular heart failure in a European population at 6 months post-implantation.
- Trial name
- NCT05876000
- Testing
- Corheart 6 Left Ventricular Assist System
- Where
- 11 sites in Austria, Germany and 1 more
- Volunteers
- 53 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
Advanced Refractory Left Ventricular Heart Failure
Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS
This is a prospective, post-market, multi-center, non-blinded, single arm study of the HeartMate 3 Left Ventricular Assist System (LVAS).
- Trial name
- SWIFT (NCT04548128)
- Testing
- HeartMate 3 Left Ventricular Assist System (HM3 LVAS)
- Where
- 32 sites in United States, Canada
- Volunteers
- 102 people
- Sponsor
- Abbott Medical Devices
Advanced Refractory Left Ventricular Heart Failure
MOMENTUM 3 IDE Clinical Study Protocol
The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
- Trial name
- HM3™ (NCT02224755)
- Testing
- HeartMate 3 LVAS, HeartMate II LVAS
- Where
- 69 sites in United States
- Volunteers
- 1,028 people
- Sponsor
- Abbott Medical Devices
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
Refractory Heart Failure, Cardiovascular Diseases (CVD)
European Study of the BrioVAD Heart Pump for Advanced Heart Failure
This clinical investigation evaluates the safety and clinical performance of the BrioVAD Left Ventricular Assist System in patients with advanced, refractory left ventricular heart failure who require mechanical circulatory…
- Trial name
- BRIOLIFE (NCT07252531)
- Testing
- LVAD implantation
- Where
- 2 sites in Netherlands
- Volunteers
- 60 people
- Sponsor
- BrioHealth BV