Clinical trials: Heart Failure NYHA Class III
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 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.
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
Chronic Heart Failure
Study of the Effect of Serelaxin on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure
This was a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II clinical study that evaluated the effect of serelaxin versus placebo (both in addition to SoC) on the release of hs-cTnI, in patients with…
- Trial name
- RELAX-Cardio (NCT02625922)
- Testing
- Serelaxin
- Where
- 9 sites in Germany, Switzerland and 1 more
- Volunteers
- 26 people
- Sponsor
- Novartis Pharmaceuticals
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
Diastolic Heart Failure NYHA Class III-IV, Diastolic Dysfunction Secondary to Aortic Stenosis
CORolla™ TAA for Heart Failure and Preserved Ejection Fraction and Diastolic Dysfunction
The study purpose is to evaluate the safety and feasibility of the CORolla™ TAA in two treatment groups, "CORolla™ Stand-alone group" and " AVR \& CORolla™ Add on group".
- Trial name
- NCT01956526
- Testing
- CORolla™ TAA device
- Where
- 2 sites in Italy
- Volunteers
- 12 people
- Sponsor
- CorAssist Cadiovascular Ltd.
Heart Failure, Congestive
ZP120 Add-on to Furosemide in Treatment of Acute or Sub-Acute Decompensated Heart Failure
The main purpose of this study is to see if the experimental drug ZP120, when given with the approved drug furosemide to patients with acute or sub-acute heart failure, can reduce the amount of fluid in the patients' lungs and…
- Trial name
- NCT00283361
- Testing
- ZP120, I.v. catherization, 6-minutes walk performance
- Where
- 22 sites in United States
- Volunteers
- 130 people
- Sponsor
- Zealand Pharma
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
International Study to Determine if AdreView Heart Function Scan Can be Used to Identify Patients With Mild or Moderate Heart Failure (HF) That Benefit From Implanted Medical Device
This is an event-driven Phase IIIb, multicentre, randomised, clinical study to demonstrate the efficacy of AdreView™ imaging for appropriately guiding the decision of implantable cardioverter defibrillator (ICD) implantation, in…
- Trial name
- ADMIRE-ICD (NCT02656329)
- Testing
- Iobenguane I -123 Injection, Implantable Cardioverter Defibrillator, Thyroid blocking
- Where
- 94 sites in United States, Canada and 8 more
- Volunteers
- 395 people
- Sponsor
- GE Healthcare
NYHA Class III Heart Failure
Bioimpedance Spectroscopy Compared to CardioMEMS™
Comparison of changes in diastolic pulmonary artery pressure as measured by CardioMEMS™ to impedance parameters as measured by ImpediMed's BIS technology.
- Trial name
- NCT02857231
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- ImpediMed Limited
HFrEF - Heart Failure With Reduced Ejection Fraction, HFpEF - Heart Failure With Preserved Ejection Fraction
Study of JK07 in Patients With Heart Failure and WHO Group 2 Combined Post- and Pre-Capillary Pulmonary Hypertension
This is a Phase 2a, open-label, multiple-dose study to assess the safety, tolerability, and efficacy of JK07 in participants 18 to 85 years of age with diagnosed HF and cpcPH.
- Conditions
- HFrEF - Heart Failure With Reduced Ejection Fraction, HFpEF - Heart Failure With Preserved Ejection Fraction, Group 2 Pulmonary Hypertension
- Trial name
- RENEU-PH (NCT07221513)
- Testing
- JK07
- Where
- United States
- Sponsor
- Salubris Biotherapeutics 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 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.
Congestive Heart Failure, Heart Failure
AB-1002 in Patients With Class III Heart Failure
This is a Phase 1, prospective, multi-center, open-label, sequential dose escalation study to explore the safety, feasibility, and efficacy of a single intracoronary infusion of AB-1002 in patients with NYHA Class III heart…
- Conditions
- Congestive Heart Failure, Heart Failure, Heart Disease, Ischemic, Cardiovascular Diseases
- Trial name
- NAN-CS101 (NCT04179643)
- Testing
- 3 x 10e13vg AB-1002
- Where
- 4 sites in United States
- Volunteers
- 11 people
- Sponsor
- AskBio Inc
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