Status:
UNKNOWN
NoYA RAISE Trial II (Radiofrequency Ablation-Based Interatrial Shunt for Heart Failure)
Lead Sponsor:
Hangzhou NOYA MedTech Co. Ltm.
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A Prospective, Multiple Center, and Objective Performance Criteria Study to Evaluate the NoYA™ Radiofrequency Interatrial Shunt System manufactured by NoYA Medtech (Hangzhou) Co., Ltd. for the Treatme...
Detailed Description
This is a prospective, multi-center and objective performance criteria study to evaluate the effectiveness and safety of the NoYA™ Radiofrequency Interatrial Shunt System for the treatment of chronic ...
Eligibility Criteria
Inclusion
- 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
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- Bacterial endocarditis.
- 6-minute walk test distance \<100m or \> 450m.
- 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.
- Right heart failure
- Pulmonary arterial hypertension (TTE or cardiac catheterization shows pulmonary artery systolic pressure\>70mmHg)
- Life expectancy less than 12 months.
- In the opinion of the investigator, the subject is not an appropriate candidate for the study.
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05375110
Start Date
March 10 2021
End Date
December 31 2023
Last Update
May 16 2022
Active Locations (31)
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1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
2
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
3
Fuwai Hospital
Beijing, Beijing Municipality, China
4
Peking University Third Hospital
Beijing, Beijing Municipality, China