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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: NoYA™ Radiofrequency Interatrial Shunt System

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Sun, MD; Phone Number: +86 13815860536; Email: weisun7919@njmu.edu.cn

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China
      • Recruiting
      • The First Affiliated Hospital of Bengbu Medical College
      • Contact: Bi Tang
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Xuanwu Hospital Capital Medical University
      • Contact: Chunlin Yin
    • Beijing, Beijing, China
      • Recruiting
      • Fuwai Hospital
      • Contact: yongjian Wu
    • Beijing, Beijing, China
      • Recruiting
      • Peking University Third Hospital
      • Contact: Yida Tang
      • Contact: Jin Bai
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Anzhen Hospital, Capital Medical University
      • Contact: Yujie Zhou
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • The First Affiliated Hospital of Fujian Medical University
      • Contact: Dajun Chai
    • Fuzhou, Fujian, China
      • Recruiting
      • Fujian Medical University Union Hospital
      • Contact: lianglong chen
    • Xiamen, Fujian, China
      • Recruiting
      • The First Affiliated Hospital of Xiamen University
      • Contact: Qiang Xie
    • Xiamen, Fujian, China
      • Recruiting
      • Xiamen Cardiovascular Hospital Xiamen University
      • Contact: Yan Wang
  • Guangdong
    • Zhuhai, Guangdong, China
      • Recruiting
      • Zhuhai People'S Hospital
      • Contact: Xiaofei Jiang
  • Hainan
    • Hainan, Hainan, China
      • Recruiting
      • Hainan General Hospital
      • Contact: Sheng Wang
  • Hebei
    • Shijiazhuang, Hebei, China
      • Recruiting
      • Shijiazhuang People's Hospital
      • Contact: Jie Mi
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Provincial Chest Hospital
      • Contact: Yiqiang Yuan
    • Zhengzhou, Henan, China
      • Recruiting
      • The 7th People Hospital of Zhengzhou
      • Contact: Shenwei Zhang
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Wuhan Asia Heart Hospital
      • Contact: Xi Su
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Hunan Provincial People's Hospital
      • Contact: Jin He
    • Changsha, Hunan, China
      • Recruiting
      • The Second Xiangya Hospital of Central South University
      • Contact: Zhenfei Fang
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • The First Affiliated Hospital of Nanjing medical University
      • Contact: Xiangqing Kong
    • Yangzhou, Jiangsu, China
      • Recruiting
      • Northern Jiangsu People's Hospital
      • Contact: Shenghu He
  • Liaoning
    • Dalian, Liaoning, China
      • Recruiting
      • The First Affiliated Hospital of Dalian Medical University
      • Contact: Ran Guo
    • Shenyang, Liaoning, China
      • Recruiting
      • General Hospital of Northern Theater Command
      • Contact: Yaling Han
  • Shandong
    • Yantai, Shandong, China
      • Recruiting
      • Yantai YuHuangDin Hospital
      • Contact: FaTao Ren
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Daxin Zhou
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai 6th people's hospital
      • Contact: Chengxing Shen
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai General Hospital
      • Contact: Wenyi Yang
    • Shanghai, Shanghai, China
      • Recruiting
      • The Shanghai Ninth People's Hospital affiliated with the Shanghai Jiao Tong University School of Medicine
      • Contact: changqian wang
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital of Sichuan University
      • Contact: Mao Chen
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin First Central Hospital
      • Contact: Chengzhi Lu
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The Second Affiliated Hospital Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Sir Run Run Shaw Hospital affiliated with the Zhejiang University School of Medicine
      • Contact: guosheng Fu
    • Ningbo, Zhejiang, China
      • Recruiting
      • Ningbo First Hospital
      • Contact: Huimin Chu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: NoYA™ Radiofrequency Interatrial Shunt System; NoYA™ Radiofrequency Interatrial Shunt System include Adjustable Interatrial Shunt System and Radiofrequency Ablation Generator.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hangzhou NOYA MedTech Co. Ltm.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Heart Failure; Heart Failure with Preserved Ejection Fraction [HFpEF]; Heart Failure with Reduced Ejection Fraction [HFrEF]
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: NOYA-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No