Clinical trials: Refractory Heart Failure
Refractory Heart Failure
Levacor™ Ventricular Assist Device (VAD) Bridge to Transplant Study
The Levacor™ Ventricular Assist Device (VAD) has been designed for mechanical circulatory support in heart failure patients. The purpose of this clinical study is to determine its safety and efficacy as a bridge to transplant…
- Trial name
- NCT01001793
- Testing
- Levacor Ventricular Assist Device
- Where
- 6 sites in United States
- Volunteers
- 15 people
- Sponsor
- World Heart Corporation
Lymphoma
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)
To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter referred to as Revlimid) under actual conditions of use in patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter…
- Trial name
- NCT03098589
- Testing
- Revlimid
- Where
- Japan
- Volunteers
- 1,149 people
- Sponsor
- Celgene
Heart Failure, Congestive
Randomized Trial for Patients With Chronic Heart Failure With Acute Decompensation
The Company's proprietary products are based on Orqis Medical's hypothesis, supported by early clinical data, that increasing and maintaining continuous blood flow in the descending aorta, known as continuous aortic flow…
- Trial name
- NCT00357591
- Testing
- Continuous Aortic Flow Augmentation
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Orqis Medical Corporation
Cardiovascular Diseases, Heart Diseases
Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure
The goal of this study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3 Left Ventricular Assist System when used for the treatment of advanced, refractory, left…
- Conditions
- Cardiovascular Diseases, Heart Diseases, Heart Failure
- Trial name
- INNOVATE (NCT06310031)
- Testing
- BrioVAD System, HeartMate 3
- Where
- 47 sites in United States
- Volunteers
- 780 people
- Sponsor
- BrioHealth Solutions, Inc.
Heart Decompensation
Levosimendan Compassionate Use in Pediatric Patients With Advanced Decompensated Heart Failure
Open label study of levosimendan; planned comparison for effectiveness and safety to historic matched case controls from participating sites.
- Trial name
- NCT02973620
- Testing
- Levosimendan
- Sponsor
- Tenax Therapeutics, Inc.
Right Heart Failure
Safety and Feasibility of the CorVad Percutaneous Ventricular Assist System in Refractory Right Heart Failure
The goal of this clinical trial is to evaluate the safety and feasibility of the CorVad Percutaneous Ventricular Assist System (Device model: CorVad RS) in patients with right heart failure who continue to experience hemodynamic…
- Trial name
- NCT07704424
- Testing
- CorVad Percutaneous Ventricular Assist System
- Where
- 2 sites in China
- Volunteers
- 6 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
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
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
Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS
This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.
- Trial name
- NCT01639495
- Testing
- THERMOCOOL® SMARTTOUCH™ Catheter
- Where
- 20 sites in United States
- Volunteers
- 148 people
- Sponsor
- Biosense Webster, Inc.
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
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
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
Heart Failure, Congestive
Dose Escalation Study of KW-3902 on Diuresis in Subjects With Congestive Heart Failure (CHF).
The purpose of this study is to evaluate the safety of KW-3902IV compared to placebo and to determine the diuretic effect of KW-3902IV compared to placebo in patients hospitalized with volume overload due to CHF who are…
- Trial name
- NCT00159627
- Testing
- KW-3902IV
- Where
- 10 sites in United States
- Volunteers
- 52 people
- Sponsor
- NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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
Multiple Myeloma
A Safety and Efficacy Study of Revlimid® 5 mg Capsules in Patients With Relapsed or Refractory Multiple Myeloma Who Have Received Long-term Treatment With it Under the Actual Condition of Use
To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in patients with "relapsed or refractory multiple myeloma" (hereinafter referred to as "relapsed or refractory MM") who have…
- Trial name
- NCT02922543
- Where
- Japan
- Volunteers
- 361 people
- Sponsor
- Celgene
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
Heart Failure
Cardiac Contractility Modulation (CCM) Therapy in Subjects With Medically Refractory Heart Failure
The study is designed to substantiate the efficacy of Cardiac Contractility Modulation (CCM) in the heart failure population with ejection fraction ranging between 25 and 45%.
- Trial name
- IMPULSE-HF (NCT02857309)
- Testing
- OPTIMIZER, Optimal medical therapy
- Where
- 8 sites in Austria, Germany and 2 more
- Volunteers
- 50 people
- Sponsor
- Impulse Dynamics