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

Hangzhou NOYA MedTech

Status: Unknown

Conditions: Heart Failure

Treatments: Device: NoYA™ Radiofrequency Interatrial Shunt System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05375110

NOYA-01

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age≥18 years old.

2. Chronic symptomatic Heart Failure (HF) documented by one or more of the following:

   1. 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;
   2. 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).

3. 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.

4. LV ejection fraction (EF) ≥15% measured by echocardiography in the last 6 months.

5. Invasive hemodynamic measurements showed mLAP or end-expiratory resting PCWP≥15mmHg, and mLAP or PCWP-RAP ≥5mmHg.

6. 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

1. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
2. Bacterial endocarditis.
3. 6-minute walk test distance <100m or > 450m.
4. History of atrial septum implantation (e.g. atrial septum occlusion, patent foramen ovale occlusion) or inferior vena cava filter.
5. 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.
6. History of cardiac resynchronization therapy (CRT/CRT-D) or implantable cardioverter-defibrillator (ICD) implantation within the past 6 months.
7. Right heart failure
8. Pulmonary arterial hypertension (TTE or cardiac catheterization shows pulmonary artery systolic pressure>70mmHg)
9. Life expectancy less than 12 months.
10. In the opinion of the investigator, the subject is not an appropriate candidate for the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

NoYA™ Radiofrequency Interatrial Shunt System

Experimental group

Description:

Eligible patients will be enrolled and undergo radiofrequency ablation of the interatrial procedure with the NoYA™ Radiofrequency Interatrial Shunt System (Noya Medtech).

Treatment:

Device: NoYA™ Radiofrequency Interatrial Shunt System