Clinical trials: NYHA Class III Heart Failure
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, NYHA Class III Heart Failure
NORM-HF Pivotal Study
This is an international, multi-center, prospective, randomized, open-label blinded endpoint study designed to demonstrate that use of the FIRE1 NORM™ System in the management of New York Heart Association Class II/III HF…
- Conditions
- Heart Failure, NYHA Class III Heart Failure, NYHA Class II Heart Failure
- Trial name
- NORM-HF (NCT07574593)
- Testing
- IVC Sensor
- Where
- 25 sites in United States
- Volunteers
- 800 people
- Sponsor
- Foundry Innovation & Research 1, Limited (FIRE1)
Heart Failure NYHA Class II, Heart Failure NYHA Class III
Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
The ALLEVIATE-HF study is a prospective, randomized, controlled, blinded, multi-site, interventional, investigational device exemption (IDE) pivotal study.
- Trial name
- ALLEVIATE-HF (NCT04452149)
- Testing
- Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download, Medication intervention, Not Randomized to Device or Medication Intervention
- Where
- 53 sites in United States
- Volunteers
- 826 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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 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 NYHA Class II, Heart Failure NYHA Class III
CardioMEMS HF System Real-World Evidence Post-Approval Study
The purpose of this post-approval study (PAS) is to evaluate the long-term safety and effectiveness of the CardioMEMS™ HF System using real-world evidence (RWE) methods.
- Trial name
- NCT06306573
- Testing
- CardioMEMS HF System
- Where
- United States
- Volunteers
- 2,500 people
- Sponsor
- Abbott Medical Devices
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.
Heart Failure NYHA Class II, Heart Failure NYHA Class III
Cardiac Neuromodulation for Heart Failure
This investigation will evaluate the ability of the Moderato® System to safely and effectively deliver CNT, to reduce sympathetic activity in heart failure patients
- Trial name
- NCT04573699
- Testing
- CNT-HF
- Where
- Poland
- Volunteers
- 34 people
- Sponsor
- BackBeat Medical Inc
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, 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 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 NYHA Class III, Heart Failure
Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure
This retrospective, non-randomized cohort study will evaluate how well the Cordella PA Sensor System works compared to standard medication treatment in people with chronic heart failure.
- Trial name
- LOWER-PAP (NCT06783335)
- Testing
- Cordella PA Sensor System, Standard of Care Pharmacologic Therapy
- Where
- United States
- Volunteers
- 2,150 people
- Sponsor
- Endotronix, Inc.
Heart Failure NYHA Class III
SIRONA Trial Heart Failure NYHA Class III
This is a prospective, multi-center, open-label, single-arm feasibility trial to assess device safety and efficacy of the Cordella™ Heart Failure System in 10 NYHA Class III heart failure patients who will receive the Cordella™…
- Trial name
- NCT03375710
- Testing
- Cordella™ Heart Failure System
- Where
- 2 sites in Belgium, Ireland
- Volunteers
- 15 people
- Sponsor
- Endotronix, Inc.
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
Hypertension (HTN), NYHA Class III Heart Failure
Evaluate the Efficacy and Safety of SPC1001 Low in Patients With Essential Hypertension
Objective: This study aims to evaluate the safety and efficacy of the fixed-dose triple combination therapy (SPC1001 Low) of candesartan, amlodipine, and indapamide in adult patients with essential hypertension compared to…
- Conditions
- Hypertension (HTN), NYHA Class III Heart Failure, NYHA Class IV Heart Failure, Diabete Mellitus
- Trial name
- NCT07064525
- Testing
- SPC1001 Low, SPC5002, SPC5003
- Where
- South Korea
- Volunteers
- 252 people
- Sponsor
- Shin Poong Pharmaceutical Co. Ltd.
Heart Failure, Left Bundle-Branch Block
Mid-Q Response Study
The Mid-Q Response study is a prospective, multi-center, randomized controlled, interventional, single-blinded, post-market study.
- Conditions
- Heart Failure, Left Bundle-Branch Block, Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure NYHA Class II
- Trial name
- NCT04180696
- Testing
- aCRT ON, aCRT OFF
- Where
- 61 sites in Brunei, China and 8 more
- Volunteers
- 177 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure NYHA Class II, Heart Failure NYHA Class III
Step and Walking Pattern From Cardiac Monitor Study
To understand the feasibility of characterizing walking patterns in heart failure subjects and subjects at risk for arrhythmias using an investigational wearable monitor called the SWAN study system.
- Conditions
- Heart Failure NYHA Class II, Heart Failure NYHA Class III, Insertable Cardiac Monitor
- Trial name
- SWAN (NCT04971993)
- Testing
- Wearable Cardiac Monitor
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Boston Scientific Corporation
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
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
Heart Failure, Heart Failure NYHA Class III
Clinical Study to Evaluate the Predictive Value of the Heart Failure Questionnaire (HF-Q) for the Occurrence of Μajor Αdverse Cardiovascular Events (MACE) in Patients With Symptomatic Heart Failure
Cardiac Heart Failure Questionnaire HF-Q) to assess the severity of the symptoms of Heart Failure. In this study, modified and translated, the "four-point" questionnaire by Severo and his associates - Heart Failure Questionnaire…
- Conditions
- Heart Failure, Heart Failure NYHA Class III, Heart Failure NYHA Class II, Heart Failure NYHA Class IV
- Trial name
- THETIS (NCT03947853)
- Sponsor
- Elpen Pharmaceutical Co. Inc.