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

NCT05375110 | Unknown

• 1 other identifier: NOYA-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 31

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.

Conditions

Heart Failure

Keywords

Heart Failure; Heart Failure with Preserved Ejection Fraction [HFpEF]; Heart Failure with Reduced Ejection Fraction [HFrEF]

Outcome Measures

Primary Outcomes (1)

• Rate of free from death and heart failure (HF) related hospitalizations at 12 months follow-up

  1. Death: Cardiac death 2. Hospitalization：HF-related Hospitalizations

  12 months after the procedure

Secondary Outcomes (9)

• Acute device success

  Immediately post-procedure

• Acute procedural success

  Immediately post-procedure

• Change in 6-Minute Walk Test

  Baseline, 6 months, 12 months after procedure

• Change in Nt-pro BNP

  Preoperative, 1 month, 3 months, 6 months, 12 months after procedure

• Change in PCWP or Mean Left Atrial Pressure

  Before, immediately after procedure

Study Arms (1)

NoYA™ Radiofrequency Interatrial Shunt System

EXPERIMENTAL

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

Interventions

NoYA™ Radiofrequency Interatrial Shunt System DEVICE

NoYA™ Radiofrequency Interatrial Shunt System include Adjustable Interatrial Shunt System and Radiofrequency Ablation Generator.

NoYA™ Radiofrequency Interatrial Shunt System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
• Bacterial endocarditis.
• 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.

Sponsors & Collaborators

• Hangzhou NOYA MedTech Co. Ltm.: lead

Study Sites (31)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

RECRUITING

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Fuwai Hospital

Beijing, Beijing Municipality, China

RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, China

RECRUITING

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

RECRUITING

Xiamen Cardiovascular Hospital Xiamen University

Xiamen, Fujian, China

RECRUITING

Zhuhai People's Hospital

Zhuhai, Guangdong, China

RECRUITING

Hainan General Hospital

Hainan, Hainan, China

RECRUITING

Shijiazhuang People's Hospital

Shijiazhuang, Hebei, China

RECRUITING

Henan Provincial Chest Hospital

Zhengzhou, Henan, China

RECRUITING

The 7th People Hospital of Zhengzhou

Zhengzhou, Henan, China

RECRUITING

Wuhan Asia Heart Hospital

Wuhan, Hubei, China

RECRUITING

Hunan Provincial People's Hospital

Changsha, Hunan, China

RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

RECRUITING

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

RECRUITING

Yantai YuHuangDin Hospital

Yantai, Shandong, China

RECRUITING

Shanghai 6th People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

The Shanghai Ninth People's Hospital affiliated with the Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Sir Run Run Shaw Hospital affiliated with the Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Ningbo First Hospital

Ningbo, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Wei Sun, MD

CONTACT

+86 13815860536; weisun7919@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 16, 2022
• Study Start: March 10, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (31)