Back to resultsNoYA RAISE Trial II (Radiofrequency Ablation-Based Interatrial Shunt for Heart Failure)
Primary Purpose
Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NoYA™ Radiofrequency Interatrial Shunt System
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Heart Failure with Preserved Ejection Fraction [HFpEF], Heart Failure with Reduced Ejection Fraction [HFrEF]
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- Bacterial endocarditis.
- 6-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.
Sites / Locations
- The First Affiliated Hospital of Bengbu Medical CollegeRecruiting
- Beijing Anzhen Hospital, Capital Medical UniversityRecruiting
- Fuwai HospitalRecruiting
- Peking University Third HospitalRecruiting
- Xuanwu Hospital Capital Medical UniversityRecruiting
- Fujian Medical University Union HospitalRecruiting
- The First Affiliated Hospital of Fujian Medical UniversityRecruiting
- The First Affiliated Hospital of Xiamen UniversityRecruiting
- Xiamen Cardiovascular Hospital Xiamen UniversityRecruiting
- Zhuhai People's HospitalRecruiting
- Hainan General HospitalRecruiting
- Shijiazhuang People's HospitalRecruiting
- Henan Provincial Chest HospitalRecruiting
- The 7th People Hospital of ZhengzhouRecruiting
- Wuhan Asia Heart HospitalRecruiting
- Hunan Provincial People's HospitalRecruiting
- The Second Xiangya Hospital of Central South UniversityRecruiting
- The First Affiliated Hospital of Nanjing Medical UniversityRecruiting
- Northern Jiangsu People's HospitalRecruiting
- The First Affiliated Hospital of Dalian Medical UniversityRecruiting
- General Hospital of Northern Theater CommandRecruiting
- Yantai YuHuangDin HospitalRecruiting
- Shanghai 6th People's HospitalRecruiting
- Shanghai General HospitalRecruiting
- The Shanghai Ninth People's Hospital affiliated with the Shanghai Jiao Tong University School of MedicineRecruiting
- Zhongshan Hospital, Fudan UniversityRecruiting
- West China Hospital of Sichuan UniversityRecruiting
- Tianjin First Central HospitalRecruiting
- Sir Run Run Shaw Hospital affiliated with the Zhejiang University School of MedicineRecruiting
- The Second Affiliated Hospital Zhejiang University School of MedicineRecruiting
- Ningbo First HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NoYA™ Radiofrequency Interatrial Shunt System
Arm Description
Eligible patients will be enrolled and undergo radiofrequency ablation of the interatrial procedure with the NoYA™ Radiofrequency Interatrial Shunt System (Noya Medtech).
Outcomes
Primary Outcome Measures
Rate of free from death and heart failure (HF) related hospitalizations at 12 months follow-up
Death: Cardiac death
Hospitalization：HF-related Hospitalizations
Secondary Outcome Measures
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.
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).
Change in 6-Minute Walk Test
The change of 6-minute walk test distance between baseline, 6 months, and 12 months follow-up.
Change in Nt-pro BNP
Change in Nt-pro BNP between preoperative, 1 month, 3 months, 6 months, and 12 months follow-up.
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.
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.
Change in NYHA Class
Preoperative, 1 month, 3 months, 6 months, and 12 months postoperative cardiac function class (NYHA class).
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.
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.
Full Information
NCT ID
NCT05375110
First Posted
May 10, 2022
Last Updated
May 10, 2022
Sponsor
Hangzhou NOYA MedTech Co. Ltm.
1. Study Identification
Unique Protocol Identification Number
NCT05375110
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou NOYA MedTech Co. Ltm.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Heart Failure with Preserved Ejection Fraction [HFpEF], Heart Failure with Reduced Ejection Fraction [HFrEF]
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NoYA™ Radiofrequency Interatrial Shunt System
Arm Type
Experimental
Arm Description
Eligible patients will be enrolled and undergo radiofrequency ablation of the interatrial procedure with the NoYA™ Radiofrequency Interatrial Shunt System (Noya Medtech).
Intervention Type
Device
Intervention Name(s)
NoYA™ Radiofrequency Interatrial Shunt System
Intervention Description
NoYA™ Radiofrequency Interatrial Shunt System include Adjustable Interatrial Shunt System and Radiofrequency Ablation Generator.
Primary Outcome Measure Information:
Title
Rate of free from death and heart failure (HF) related hospitalizations at 12 months follow-up
Description
Death: Cardiac death
Hospitalization：HF-related Hospitalizations
Time Frame
12 months after the procedure
Secondary Outcome Measure Information:
Title
Acute device success
Description
Acute device success is defined as the successful delivery and retraction of the device without immediate postoperative device-related technical failures or complications.
Time Frame
Immediately post-procedure
Title
Acute procedural success
Description
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).
Time Frame
Immediately post-procedure
Title
Change in 6-Minute Walk Test
Description
The change of 6-minute walk test distance between baseline, 6 months, and 12 months follow-up.
Time Frame
Baseline, 6 months, 12 months after procedure
Title
Change in Nt-pro BNP
Description
Change in Nt-pro BNP between preoperative, 1 month, 3 months, 6 months, and 12 months follow-up.
Time Frame
Preoperative, 1 month, 3 months, 6 months, 12 months after procedure
Title
Change in PCWP or Mean Left Atrial Pressure
Description
Change in resting end-expiratory PCWP (pulmonary capillary wedge pressure) or mean left atrial pressure before and immediately after the procedure.
Time Frame
Before, immediately after procedure
Title
Left-to-right Atrial Blood Shunt Evaluation
Description
Echocardiographic assessment of left-to-right atrial blood shunt at 6 months and 12 months postoperatively: peak shunt flow rate, maximum shunt orifice diameter.
Time Frame
6 months, 12 months after procedure
Title
Change in NYHA Class
Description
Preoperative, 1 month, 3 months, 6 months, and 12 months postoperative cardiac function class (NYHA class).
Time Frame
Preoperative, 1 month, 3 months, 6 months, 12 months after procedure
Title
Change in Minnesota Living with Heart Failure Questionnaire
Description
Preoperative, 1 month, 3months, 6 months, and 12 months postoperative Quality of life assessment in Minnesota Living with Heart Failure Questionnaire.
Time Frame
Preoperative, 1 month, 3 months, 6 months, 12 months after procedure
Title
Rate of re-admission, re-operation/intervention for heart failure
Description
The overall incidence of re-admission, re-operation/intervention for heart failure within 1 year.
Time Frame
12 months after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
Bacterial endocarditis.
6-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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Sun, MD
Phone
+86 13815860536
Email
weisun7919@njmu.edu.cn
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bi Tang
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yujie Zhou
Facility Name
Fuwai Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongjian Wu
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yida Tang
First Name & Middle Initial & Last Name & Degree
Jin Bai
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunlin Yin
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lianglong Chen
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dajun Chai
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Xie
Facility Name
Xiamen Cardiovascular Hospital Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Wang
Facility Name
Zhuhai People's Hospital
City
Zhuhai
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofei Jiang
Facility Name
Hainan General Hospital
City
Hainan
State/Province
Hainan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng Wang
Facility Name
Shijiazhuang People's Hospital
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Mi
Facility Name
Henan Provincial Chest Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiqiang Yuan
Facility Name
The 7th People Hospital of Zhengzhou
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shenwei Zhang
Facility Name
Wuhan Asia Heart Hospital
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Su
Facility Name
Hunan Provincial People's Hospital
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin He
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenfei Fang
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangqing Kong
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shenghu He
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran Guo
Facility Name
General Hospital of Northern Theater Command
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaling Han
Facility Name
Yantai YuHuangDin Hospital
City
Yantai
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FaTao Ren
Facility Name
Shanghai 6th People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengxing Shen
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenyi Yang
Facility Name
The Shanghai Ninth People's Hospital affiliated with the Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changqian Wang
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daxin Zhou
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mao Chen
Facility Name
Tianjin First Central Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengzhi Lu
Facility Name
Sir Run Run Shaw Hospital affiliated with the Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guosheng Fu
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianan Wang
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huimin Chu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
NoYA RAISE Trial II (Radiofrequency Ablation-Based Interatrial Shunt for Heart Failure)
We'll reach out to this number within 24 hrs