NoYA RAISE Trial II (Radiofrequency Ablation-Based Interatrial Shunt for Heart Failure)

Study Overview
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Brief Summary
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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 Treatment of Chronic Heart Failure with Elevated Left Atrial Pressure.

Detailed Description
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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 heart failure with elevated left atrial pressure. Patients with chronic heart failure with elevated left atrial pressure who meet study eligibility criteria will be enrolled and undergo radiofrequency ablation of the interatrial procedure with NoYA™ Radiofrequency Interatrial Shunt System (Noya Medtech) after signing the informed consent. The follow-up will be conducted at discharge, 1 month, 3 months, 6 months, and 12 months after the operation.

Official Title
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A Prospective, Multi-center and Objective Performance Criteria Study to Evaluate the Effectiveness and Safety of NoYA™ Radiofrequency Interatrial Shunt System for the Treatment of Chronic Heart Failure With Elevated Left Atrial Pressure

Conditions
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Heart Failure

Intervention / Treatment
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* Device: NoYA™ Radiofrequency Interatrial Shunt System


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NoYA™ Radiofrequency Interatrial Shunt System<br>Eligible patients will be enrolled and undergo radiofrequency ablation of the interatrial procedure with the NoYA™ Radiofrequency Interatrial Shunt System (Noya Medtech). | Device: NoYA™ Radiofrequency Interatrial Shunt System<br>* NoYA™ Radiofrequency Interatrial Shunt System include Adjustable Interatrial Shunt System and Radiofrequency Ablation Generator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of free from death and heart failure (HF) related hospitalizations at 12 months follow-up | Death: Cardiac death Hospitalization：HF-related Hospitalizations | 12 months after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute device success | Acute device success is defined as the successful delivery and retraction of the device without immediate postoperative device-related technical failures or complications. | Immediately post-procedure | 
| Acute procedural success | Acute procedural success is defined as no operative death immediately after the operation, successful delivery and fully retraction of the device, no need for any emergency surgery or secondary intervention (including device-related or operative approach-related), and the presence of the left-to-right atrial blood shunt (means the shunt is patent). | Immediately post-procedure | 
| Change in 6-Minute Walk Test | The change of 6-minute walk test distance between baseline, 6 months, and 12 months follow-up. | Baseline, 6 months, 12 months after procedure | 
| Change in Nt-pro BNP | Change in Nt-pro BNP between preoperative, 1 month, 3 months, 6 months, and 12 months follow-up. | Preoperative, 1 month, 3 months, 6 months, 12 months after procedure | 
| Change in PCWP or Mean Left Atrial Pressure | Change in resting end-expiratory PCWP (pulmonary capillary wedge pressure) or mean left atrial pressure before and immediately after the procedure. | Before, immediately after procedure | 
| Left-to-right Atrial Blood Shunt Evaluation | Echocardiographic assessment of left-to-right atrial blood shunt at 6 months and 12 months postoperatively: peak shunt flow rate, maximum shunt orifice diameter. | 6 months, 12 months after procedure | 
| Change in NYHA Class | Preoperative, 1 month, 3 months, 6 months, and 12 months postoperative cardiac function class (NYHA class). | Preoperative, 1 month, 3 months, 6 months, 12 months after procedure | 
| Change in Minnesota Living with Heart Failure Questionnaire | Preoperative, 1 month, 3months, 6 months, and 12 months postoperative Quality of life assessment in Minnesota Living with Heart Failure Questionnaire. | Preoperative, 1 month, 3 months, 6 months, 12 months after procedure | 
| Rate of re-admission, re-operation/intervention for heart failure | The overall incidence of re-admission, re-operation/intervention for heart failure within 1 year. | 12 months after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Heart Failure with Preserved Ejection Fraction [HFpEF], Heart Failure with Reduced Ejection Fraction [HFrEF]