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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05375110
• Other study ID #: NOYA-01
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: Hangzhou NOYA MedTech Co. Ltm.
• Contact: Wei Sun, MD
• Phone: +86 13815860536
• Email: weisun7919[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing
China	Fuwai Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	Xuanwu Hospital Capital Medical University	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Hainan General Hospital	Hainan	Hainan
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	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Ningbo First Hospital	Ningbo	Zhejiang
China	Shanghai 6th People's Hospital	Shanghai	Shanghai
China	Shanghai General Hospital	Shanghai	Shanghai
China	The Shanghai Ninth People's Hospital affiliated with the Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai
China	General Hospital of Northern Theater Command	Shenyang	Liaoning
China	Shijiazhuang People's Hospital	Shijiazhuang	Hebei
China	Tianjin First Central Hospital	Tianjin	Tianjin
China	Wuhan Asia Heart Hospital	Wuhan	Hubei
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Xiamen Cardiovascular Hospital Xiamen University	Xiamen	Fujian
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu
China	Yantai YuHuangDin Hospital	Yantai	Shandong
China	Henan Provincial Chest Hospital	Zhengzhou	Henan
China	The 7th People Hospital of Zhengzhou	Zhengzhou	Henan
China	Zhuhai People's Hospital	Zhuhai	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou NOYA MedTech Co. Ltm.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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