NoYA RAISE Trial II (Radiofrequency Ablation-Based Interatrial Shunt for Heart Failure)
NCT ID: NCT05375110
Last Updated: 2022-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2021-03-10
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NoYA™ Radiofrequency Interatrial Shunt System
Eligible patients will be enrolled and undergo radiofrequency ablation of the interatrial procedure with the NoYA™ Radiofrequency Interatrial Shunt System (Noya Medtech).
NoYA™ Radiofrequency Interatrial Shunt System
NoYA™ Radiofrequency Interatrial Shunt System include Adjustable Interatrial Shunt System and Radiofrequency Ablation Generator.
Interventions
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NoYA™ Radiofrequency Interatrial Shunt System
NoYA™ Radiofrequency Interatrial Shunt System include Adjustable Interatrial Shunt System and Radiofrequency Ablation Generator.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Hangzhou NOYA MedTech Co. Ltm.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Fuwai Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, China
Zhuhai People's Hospital
Zhuhai, Guangdong, China
Hainan General Hospital
Hainan, Hainan, China
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, China
Henan Provincial Chest Hospital
Zhengzhou, Henan, China
The 7th People Hospital of Zhengzhou
Zhengzhou, Henan, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
General Hospital of Northern Theater Command
Shenyang, Liaoning, China
Yantai YuHuangDin Hospital
Yantai, Shandong, China
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
The Shanghai Ninth People's Hospital affiliated with the Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China
Sir Run Run Shaw Hospital affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Ningbo First Hospital
Ningbo, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Bi Tang
Role: primary
Yujie Zhou
Role: primary
Yongjian Wu
Role: primary
Yida Tang
Role: primary
Jin Bai
Role: backup
Chunlin Yin
Role: primary
Lianglong Chen
Role: primary
Dajun Chai
Role: primary
Qiang Xie
Role: primary
Yan Wang
Role: primary
Xiaofei Jiang
Role: primary
Sheng Wang
Role: primary
Jie Mi
Role: primary
Yiqiang Yuan
Role: primary
Shenwei Zhang
Role: primary
Xi Su
Role: primary
Jin He
Role: primary
Zhenfei Fang
Role: primary
Xiangqing Kong
Role: primary
Shenghu He
Role: primary
Ran Guo
Role: primary
Yaling Han
Role: primary
FaTao Ren
Role: primary
Chengxing Shen
Role: primary
Wenyi Yang
Role: primary
Changqian Wang
Role: primary
Daxin Zhou
Role: primary
Mao Chen
Role: primary
Chengzhi Lu
Role: primary
Guosheng Fu
Role: primary
Jianan Wang
Role: primary
Huimin Chu
Role: primary
Other Identifiers
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NOYA-01
Identifier Type: -
Identifier Source: org_study_id
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