NoYA RAISE Trial II (Radiofrequency Ablation-Based Interatrial Shunt for Heart Failure) (NCT05375110) | Clinical Trial Compass
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NoYA RAISE Trial II (Radiofrequency Ablation-Based Interatrial Shunt for Heart Failure)
China120 participantsStarted 2021-03-10
Plain-language summary
A Prospective, Multiple Center, and Objective Performance Criteria Study to Evaluate the NoYAâ„¢ Radiofrequency Interatrial Shunt System manufactured by NoYA Medtech (Hangzhou) Co., Ltd. for the Treatment of Chronic Heart Failure with Elevated Left Atrial Pressure.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age≥18 years old.
✓. Chronic symptomatic Heart Failure (HF) documented by one or more of the following:
✓. New York Heart Association (NYHA) Class II/III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit; or signs (Any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months;
✓. One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify).
✓. Sustained and stable GDMT (guideline-directed medical therapy) for heart failure according to the 2017 ACC/AHA/HFSA guidelines management as well as potential complications of heart failure management, heart failure symptoms remain uncontrolled.
✓. LV ejection fraction (EF) ≥15% measured by echocardiography in the last 6 months.
✓. Invasive hemodynamic measurements showed mLAP or end-expiratory resting PCWP≥15mmHg, and mLAP or PCWP-RAP ≥5mmHg.
✓. Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, as approved by the IRB.
Exclusion criteria
✕. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
✕. Bacterial endocarditis.
What they're measuring
1
Rate of free from death and heart failure (HF) related hospitalizations at 12 months follow-up
✕. History of atrial septum implantation (e.g. atrial septum occlusion, patent foramen ovale occlusion) or inferior vena cava filter.
✕. History of myocardial infarction (MI), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG) within the past 3 months; Untreated severe coronary artery stenosis which requires revascularization.
✕. History of cardiac resynchronization therapy (CRT/CRT-D) or implantable cardioverter-defibrillator (ICD) implantation within the past 6 months.