Clinical trial NCT05375110: NoYA RAISE Trial II (Radiofrequency Ablation-Based Interatrial Shunt for Heart Failure)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Heart Failure with Preserved Ejection Fraction [HFpEF]
Heart Failure with Reduced Ejection Fraction [HFrEF]
Lead sponsor: Hangzhou NOYA MedTech Co. Ltm.
Sponsor class: INDUSTRY
First posted: 2022-05-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Treatment of Chronic Heart Failure with Elevated Left Atrial Pressure.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of free from death and heart failure (HF) related hospitalizations at 12 months follow-up
timeFrame: 12 months after the procedure
Secondary outcomes:
measure: Acute device success
timeFrame: Immediately post-procedure
measure: Acute procedural success
timeFrame: Immediately post-procedure
measure: Change in 6-Minute Walk Test
timeFrame: Baseline, 6 months, 12 months after procedure
measure: Change in Nt-pro BNP
timeFrame: Preoperative, 1 month, 3 months, 6 months, 12 months after procedure
measure: Change in PCWP or Mean Left Atrial Pressure
timeFrame: Before, immediately after procedure
measure: Left-to-right Atrial Blood Shunt Evaluation
timeFrame: 6 months, 12 months after procedure
measure: Change in NYHA Class
timeFrame: Preoperative, 1 month, 3 months, 6 months, 12 months after procedure
measure: Change in Minnesota Living with Heart Failure Questionnaire
timeFrame: Preoperative, 1 month, 3 months, 6 months, 12 months after procedure
measure: Rate of re-admission, re-operation/intervention for heart failure
timeFrame: 12 months after procedure
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Xiamen
country: China
facility: Xiamen Cardiovascular Hospital Xiamen University
state: Fujian
city: Zhuhai
country: China
facility: Zhuhai People's Hospital
state: Guangdong
city: Hainan
country: China
facility: Hainan General Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: Shijiazhuang People's Hospital
state: Hebei
city: Zhengzhou
country: China
facility: Henan Provincial Chest Hospital
state: Henan
city: Zhengzhou
country: China
facility: The 7th People Hospital of Zhengzhou
state: Henan
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: Yantai
country: China
facility: Yantai YuHuangDin Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai 6th People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Shanghai
country: China
facility: The Shanghai Ninth People's Hospital affiliated with the Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin First Central Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital affiliated with the Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
Study officials:
References: