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Heart FailureNCT05375110

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

A study testing NoYA™ Radiofrequency Interatrial Shunt System in people with Heart Failure, run by Hangzhou NOYA MedTech Co. Ltm. at 31 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
NoYA™ Radiofrequency Interatrial Shunt System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
31 sitesChina
Study dates
10 Mar 2021to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

31 sites in 1 country.

Wei Sun, MD contact

+86 13815860536

weisun7919@njmu.edu.cn

31 sites in 1 country

China31 sites, 31 recruiting

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Yujie Zhou

    Recruiting

  • Fuwai Hospital

    Beijing, Beijing Municipality

    Yongjian Wu

    Recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality

    Yida Tang

    Jin Bai

    Recruiting

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality

    Chunlin Yin

    Recruiting

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui

    Bi Tang

    Recruiting

  • Hunan Provincial People's Hospital

    Changsha, Hunan

    Jin He

    Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

    Zhenfei Fang

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

    Mao Chen

    Recruiting

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

    Ran Guo

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

    Lianglong Chen

    Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian

    Dajun Chai

    Recruiting

  • Hainan General Hospital

    Hainan, Hainan

    Sheng Wang

    Recruiting

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

    Hangzhou, Zhejiang

    Guosheng Fu

    Recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Jianan Wang

    Recruiting

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu

    Xiangqing Kong

    Recruiting

  • Ningbo First Hospital

    Ningbo, Zhejiang

    Huimin Chu

    Recruiting

  • Shanghai 6th People's Hospital

    Shanghai, Shanghai Municipality

    Chengxing Shen

    Recruiting

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality

    Wenyi Yang

    Recruiting

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

    Shanghai, Shanghai Municipality

    Changqian Wang

    Recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality

    Daxin Zhou

    Recruiting

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning

    Yaling Han

    Recruiting

  • Shijiazhuang People's Hospital

    Shijiazhuang, Hebei

    Jie Mi

    Recruiting

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality

    Chengzhi Lu

    Recruiting

  • Wuhan Asia Heart Hospital

    Wuhan, Hubei

    Xi Su

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

    Qiang Xie

    Recruiting

  • Xiamen Cardiovascular Hospital Xiamen University

    Xiamen, Fujian

    Yan Wang

    Recruiting

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu

    Shenghu He

    Recruiting

  • Yantai YuHuangDin Hospital

    Yantai, Shandong

    FaTao Ren

    Recruiting

  • Henan Provincial Chest Hospital

    Zhengzhou, Henan

    Yiqiang Yuan

    Recruiting

  • The 7th People Hospital of Zhengzhou

    Zhengzhou, Henan

    Shenwei Zhang

    Recruiting

  • Zhuhai People's Hospital

    Zhuhai, Guangdong

    Xiaofei Jiang

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Heart Failure
Being tested
NoYA™ Radiofrequency Interatrial Shunt System
Keywords
Heart Failure, Heart Failure with Preserved Ejection Fraction [HFpEF], Heart Failure with Reduced Ejection Fraction [HFrEF]
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NoYA™ Radiofrequency Interatrial Shunt SystemDevice

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

Study groups in NCT05375110
Study groupRoleWhat they receive
NoYA™ Radiofrequency Interatrial Shunt SystemExperimentalEligible patients will be enrolled and undergo radiofrequency ablation of the interatrial procedure with the NoYA™ Radiofrequency Interatrial Shunt System (Noya Medtech).
Receives: Device: NoYA™ Radiofrequency Interatrial Shunt System

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months after the procedure

Secondary outcomes (9)

  1. 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.

    Measured: Immediately post-procedure

  2. 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).

    Measured: Immediately post-procedure

  3. Change in 6-Minute Walk Test

    The change of 6-minute walk test distance between baseline, 6 months, and 12 months follow-up.

    Measured: Baseline, 6 months, 12 months after procedure

  4. Change in Nt-pro BNP

    Change in Nt-pro BNP between preoperative, 1 month, 3 months, 6 months, and 12 months follow-up.

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

  5. 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.

    Measured: Before, immediately after procedure

  6. 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.

    Measured: 6 months, 12 months after procedure

  7. Change in NYHA Class

    Preoperative, 1 month, 3 months, 6 months, and 12 months postoperative cardiac function class (NYHA class).

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

  8. 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.

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

  9. 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.

    Measured: 12 months after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2022
  2. Study start10 Mar 2021
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05375110
Sponsor's protocol ID
NOYA-01
Status last verified
May 2022
First submitted
10 May 2022
Last updated
16 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing NoYA™ Radiofrequency Interatrial Shunt System in people with Heart Failure, run by Hangzhou NOYA MedTech Co. Ltm. at 31 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wei Sun, MD (+86 13815860536, weisun7919@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of free from death and heart failure (HF) related hospitalizations at 12 months follow-up (time frame: 12 months after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05375110.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.

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