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

May 10, 2022 updated by: Hangzhou NOYA MedTech Co. Ltm.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of free from death and heart failure (HF) related hospitalizations at 12 months follow-up
Time Frame: 12 months after the procedure
  1. Death: Cardiac death
  2. Hospitalization：HF-related Hospitalizations
12 months after the procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute device success
Time Frame: Immediately post-procedure
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
Time Frame: Immediately post-procedure
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
Time Frame: Baseline, 6 months, 12 months after procedure
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
Time Frame: Preoperative, 1 month, 3 months, 6 months, 12 months after procedure
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
Time Frame: Before, immediately after procedure
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
Time Frame: 6 months, 12 months after procedure
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
Time Frame: Preoperative, 1 month, 3 months, 6 months, 12 months after procedure
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
Time Frame: Preoperative, 1 month, 3 months, 6 months, 12 months after procedure
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
Time Frame: 12 months after procedure
The overall incidence of re-admission, re-operation/intervention for heart failure within 1 year.
12 months after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hangzhou NOYA MedTech Co. Ltm.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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