Clinical trials: Heart Failure New York Heart Association Class III
- Condition Heart Failure New York Heart Association Class III
- Funder type Industry (pharma, biotech, devices)
Heart Failure, Heart Failure, Systolic
Hemodynamic-GUIDEd Management of Heart Failure
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for…
- Conditions
- Heart Failure, Heart Failure, Systolic, Heart Failure, Diastolic, Heart Failure NYHA Class II
- Trial name
- GUIDE-HF (NCT03387813)
- Testing
- CardioMEMS™ HF System
- Where
- 129 sites in United States, Canada
- Volunteers
- 2,358 people
- Sponsor
- Abbott Medical Devices
Heart Failure NYHA Class III
PROACTIVE-HF IDE Trial Heart Failure NYHA Class III
This is a prospective, open- label, single arm, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients compared to a Performance Goal (PG).
- Trial name
- PROACTIVE-HF (NCT04089059)
- Testing
- Cordella™ Pulmonary Artery Sensor System
- Where
- 74 sites in United States, Belgium and 1 more
- Volunteers
- 738 people
- Sponsor
- Endotronix, Inc.
Heart Failure
TRI-V Heart Failure (HF) Implanted Cardioverter Defibrillator (ICD) Study
It's the aim of this study to investigate the impact of Right Ventricular (RV) lead position (RV-apex, His bundle area, RV-apex+His bundle area) in combination with individually optimized Left Ventricular (LV) lead placement and…
- Trial name
- TRI-V (NCT00746135)
- Testing
- Device Implantation
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Congestive Heart Failure
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and…
- Trial name
- NECTAR-HF (NCT01385176)
- Testing
- Implant of investigational device system, Titration during the randomization phase, Titration after the randomization phase
- Where
- 21 sites in Belgium, Czechia and 6 more
- Volunteers
- 118 people
- Sponsor
- Boston Scientific Corporation
NYHA Class III Heart Failure
Wireless, Intermittent Monitoring of Right Heart Pressures in HF
The purpose of the trial is to evaluate the wireless monitoring of pulmonary artery pressure using the CardioMEMS HF Pressure Measurement System in adult subjects with NYHA Class III Heart Failure.
- Trial name
- NCT01162707
- Testing
- CardioMEMS HF Pressure Measurement System
- Where
- 4 sites in United States
- Volunteers
- 17 people
- Sponsor
- CardioMEMS
Advanced Heart Failure, Ischemic Heart Failure
HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery
This clinical study will evaluate the safety and tolerability of HiCM-188, an investigational allogeneic induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy, in adults with advanced heart failure who are undergoing…
- Trial name
- NCT07646210
- Testing
- HiCM-188 Cells
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- HELP Therapeutics Co., Ltd.
NYHA Class III Heart Failure, NYHA Class IV Heart Failure
Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure: FIX-HF-5C
The objective of this investigation is to evaluate the safety and effectiveness of the OPTIMIZER® System in subjects with medically refractory moderate-to-severe heart failure.
- Trial name
- FIX-HF-5C (NCT01381172)
- Testing
- Optimizer System, No intervention: Optimal medical therapy
- Where
- 42 sites in United States, Czechia and 1 more
- Volunteers
- 160 people
- Sponsor
- Impulse Dynamics
Hyponatremia
THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation
The purpose of this study is to determine the safety and efficacy of lixivaptan in the treatment of hyponatremia in patients with congestive heart failure.
- Trial name
- NCT00578695
- Testing
- lixivaptan
- Where
- 287 sites in United States, Argentina and 13 more
- Volunteers
- 652 people
- Sponsor
- CardioKine Inc.
Heart Failure NYHA Class III
SIRONA 2 Trial Heart Failure NYHA Class III
This is a prospective, multi-center, open-label, single-arm CE-Mark trial to assess device safety and efficacy of the Cordella PA Sensor System in up to 75 New York Heart Association (NYHA) Class III Heart Failure patients who…
- Trial name
- NCT04012944
- Testing
- Cordella™ Pulmonary Artery Sensor System
- Where
- 7 sites in Belgium, Germany and 1 more
- Volunteers
- 81 people
- Sponsor
- Endotronix, Inc.
Heart Failure
QUantum Genomics Incremental Dosing in Heart Failure - QUID-HF
Heart Failure (HF) a common clinical condition characterized by either by a heart that does not pump sufficiently or becomes stiff. A variety of mechanisms contribute to progressive cardiac remodeling and dysfunction.
- Trial name
- QUID-HF (NCT02780180)
- Testing
- QGC001
- Where
- 23 sites in Czechia, France and 6 more
- Volunteers
- 23 people
- Sponsor
- Quantum Genomics SA
Heart Failure, Heart Failure NYHA Class II
Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure
The purpose of BENEFIT-HF is to demonstrate the safety and effectiveness of Baroreflex Activation Therapy (BAT) with the Barostim System in participants with heart failure, defined as NYHA Functional Class II or III, LVEF < 50%…
- Conditions
- Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III
- Trial name
- BENEFIT-HF (NCT07232030)
- Testing
- Barostim System, Usual care medical management
- Where
- 20 sites in United States
- Volunteers
- 2,500 people
- Sponsor
- CVRx, Inc.
Heart Failure and Reduced Ejection Fraction, NYHA Class III Heart Failure
Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure
The purpose of this prospective, multi-center, propensity-matched coverage with evidence development (CED) study is to assess the impact of cardiac contractility modulation (CCM) on mortality and heart failure hospitalizations in…
- Trial name
- BRIGHTEN-HF (NCT07209098)
- Testing
- Cardiac Contractility Modulation (CCM)
- Where
- United States
- Volunteers
- 4,200 people
- Sponsor
- Impulse Dynamics
Heart Failure, Heart Failure NYHA Class III
An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
The purpose of this early feasibility study is to evaluate the safety and feasibility of the device for percutaneous shunting of the interatrial septum and improvement of heart failure related symptoms.
- Conditions
- Heart Failure, Heart Failure NYHA Class III, Heart Failure With Reduced Ejection Fraction, Ambulatory Heart Failure, NYHA Class IV
- Trial name
- EASE HF2 (NCT06859970)
- Testing
- PAS-C System
- Where
- 6 sites in United States
- Volunteers
- 20 people
- Sponsor
- InterShunt Technologies, Inc.
Heart Failure
C-Pulse® System European Multicenter Study
The study is designed to observe the clinical outcomes of heart failure patients treated with C-Pulse® System in the usual manner and according to the approved indications and contraindications.
- Trial name
- OPTIONS-HF (NCT01872949)
- Where
- 8 sites in Austria, Germany
- Volunteers
- 15 people
- Sponsor
- Nuwellis, Inc.
Heart Failure, Heart Failure NYHA Class II
Implementation and Cost-evaluation of a Smartphone-based Telemonitoring and Digital Support in Patients With HF
The BEDICARE-HF study aims to go further in the research on digital support. The objectives of this study are to demonstrate the feasibility, acceptability, adoption, sustainability and safety of a of a smartphone-based digital…
- Conditions
- Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
- Trial name
- BEDICARE-HF (NCT05487365)
- Testing
- Comunicare Solutions Smartphone Application, Completing a quality of life (QOL)-questionnaire
- Where
- Belgium
- Volunteers
- 330 people
- Sponsor
- Comunicare Solutions SA
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
Heart Failure NYHA Class III and Ambulatory IV
Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D
The objective of this study is to assess the safety and effectiveness of the automatic atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in the PARADYM RF SONR Cardiac Resynchronization…
- Trial name
- RESPOND-CRT (NCT01534234)
- Testing
- PARADYM RF SONR
- Where
- 125 sites in United States, Australia and 10 more
- Volunteers
- 1,039 people
- Sponsor
- MicroPort CRM
Heart Failure NYHA Class III
PRODIGY Registry in NYHA Class III Heart Failure Patients
This is an observational, prospective, single arm, multi-center registry to evaluate the Cordella™ Heart Failure System (CHFS) in up to 250 NYHA Class III HF patients .
- Trial name
- NCT03623165
- Testing
- Cordella™ Heart Failure System
- Where
- 4 sites in United States
- Volunteers
- 7 people
- Sponsor
- Endotronix, Inc.
Heart Failure, Heart Failure NYHA Class II
Heart Failure Management for Patient With CIED Remotely Monitored
This randomized, controlled, open-label, parallel, multicenter clinical study evaluates the efficacy of SmartSignalHF compared with heart failure (HF) remote monitoring (RM) standard of care in implanted patients with heart…
- Conditions
- Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure With Reduced Ejection Fraction (HFrEF)
- Trial name
- PROACT-HF (NCT07247032)
- Testing
- SmartSignalHF, HF RM standard of care
- Where
- France
- Volunteers
- 1,132 people
- Sponsor
- Implicity
Heart Failure NYHA Class II, Heart Failure NYHA Class III
PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2…
- Conditions
- Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure
- Trial name
- NCT05934487
- Testing
- Cordella™ Pulmonary Artery Sensor System
- Where
- 48 sites in United States, Belgium and 1 more
- Volunteers
- 1,750 people
- Sponsor
- Endotronix, Inc.