HARMONY Trial : To Evaluate a Therapeutic and Monitoring Device(NOVAtria System) for Heart Failure Management

May 7, 2026 updated by: United Innomed(Shanghai) Limited

The Study of a tHerApeutic and monitoRing Device iMplanted at the Atrial Septum prOvides Heart Failure maNagement in sYmptomatic Patients (HARMONY Trial)

The objective of the HARMONY trial is to evaluate the safety and efficacy of implantable left atrial pressure sensor and interatrial shunt system for the treatment of chronic heart failure with reduced left ventricular ejection fraction (HFrEF, EF ≤ 40%) and New York Heart Association(NYHA) functional Class II or Class III who at baseline are treated with guideline-directed drug and device therapies.

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.

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 (Estimated)

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.
330

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
      • Chengdu, China
        • Not yet recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
          • ZENG Jie
    • Fujian
      • Fuzhou, Fujian, China
        • Not yet recruiting
        • Fuzhou University Affiliated Provincial Hospital
        • Contact:
          • GUO Yansong
    • Gansu
      • Lanzhou, Gansu, China
        • Not yet recruiting
        • The First Hospital of Lanzhou University
        • Contact:
          • BAI Ming
    • Guangdong
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
          • JING Zhicheng
    • Guizhou
      • Guiyang, Guizhou, China
        • Not yet recruiting
        • Guizhou Provincial People's Hospital
        • Contact:
          • WU Qiang
    • Henan
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • Fuwai Central China Cardiovascular Hospital
        • Contact:
          • YUAN Yiqiang
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
          • FANG Zhenfei
      • Changsha, Hunan, China
        • Not yet recruiting
        • Xiangya Hospital of Central South University
        • Contact:
          • BAI Yongping
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
          • YANG Renqiang
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Not yet recruiting
        • Shanghai Chest Hospital
        • Contact:
          • LI Ruogu
    • Shanxi
      • Xi’an, Shanxi, China
        • Not yet recruiting
        • Xijing Hospital
        • Contact:
          • TAO Ling
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • West China Hospital
        • Contact:
          • CHEN Mao
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medcine
        • Contact:
          • WANG Jian'an
          • Phone Number: +86 0571 87783759
      • Ningbo, Zhejiang, China
        • Not yet recruiting
        • The First Affiliated Hospital of Ningbo University
        • Contact:
          • CHEN Xiaomin
      • Wenzhou, Zhejiang, China
        • Not yet recruiting
        • The First AFfiliated Hospital of MWU
        • Contact:
          • ZHOU Hao

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Main Inclusion Criteria：

  • Age ≥ 18 years old
  • Clinically diagnosed with chronic heart failure
  • Receiving guideline directed medical and device therapy (GDMT) for heart failure
  • Left ventricular ejection fraction (LVEF) ≤ 40% assessed by echocardiography

  • New York Heart Association (NYHA) functional class II or III, with NYHA II criteria met simultaneously; for NYHA III, at least one of the following must be satisfied:

    1. At least one hospitalization for heart failure within the past 12 months;
    2. Elevated BNP or NT-proBNP within 3 months prior to enrollment (under normal sinus rhythm, NT-proBNP > 900 pg/mL; under atrial fibrillation, NT-proBNP > 1500 pg/mL; under normal sinus rhythm, BNP > 300 pg/mL; under atrial fibrillation, BNP > 500 pg/mL; BNP not applicable if the patient is using ARNI);
  • Able to perform 6-minute walk test (6MWT), with a distance between 100 meters and 450 meters

Main Exclusion Criteria

  • Currently in an acute decompensation of chronic heart failure (hospitalization within 2 weeks prior to enrollment), refractory end-stage heart failure, or on the waiting list for heart transplantation (including LVAD indication);
  • BMI > 40 kg/m² or < 18.5 kg/m²;
  • Systolic blood pressure <90 or ≥160 mmHg
  • Moderate or severe aortic or mitral stenosis, or planned during the trial intervention for severe regurgitation of the aortic, mitral, tricuspid, or pulmonary valves;
  • Coronary artery disease requiring revascularization;
  • Hypertrophic cardiomyopathy, active myocarditis, cardiac tamponade or large pericardial effusion, congenital heart disease, or other causes of heart failure
  • History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 3 months
  • Severe chronic lung disease requiring oxygen therapy or long-term corticosteroids;
  • Surgery involving atrial septal puncture within 3 months before enrollment (e.g., mitral repair, atrial fibrillation ablation, LAA closure);
  • Significant RV dysfunction - TAPSE <12mm or RVFAC ≤25%
  • eGFR <25 ml/min/1.73 m^2

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: Randomized
  • Interventional Model: Parallel 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: Treatment
Treatment arm patients will undergo a right heart catheterization and invasive echocardiography to determine study eligibility and TEE guided trans-septal puncture and NOVAtria® system procedure
Device: NOVAtria System
The NOVAtria System, therapeutic and monitoring device will be implanted at interatrial septum with minimally invasive cardiac catheterization procedure
Other: Control
Control arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility, but will not have transseptal catheterization or device implantation
Other: Control
Right heart catheterization and TEE
Experimental: Roll in
Roll in arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and NOVAtria® system procedure
Device: NOVAtria System
The NOVAtria System, therapeutic and monitoring device will be implanted at interatrial septum with minimally invasive cardiac catheterization procedure

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
Primary Safety endpoint
Time Frame: 30-days after randomization
Safety-Percentage of Treatment patients experiencing major device-related adverse events.Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 30-days after randomization, compared to a pre-specified Performance Goal
30-days after randomization
Composite Primary Effective endpoint
Time Frame: Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months
Effectiveness-Hierarchical composite of death, heart transplant or left ventricular assist device (LVAD) implantation, HF hospitalizations, worsening HF events treated as an outpatient, and change in 6WMT
Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months

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.
United Innomed(Shanghai) Limited

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 16, 2026

Primary Completion (Estimated)

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.
June 1, 2028

Study Completion (Estimated)

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.
June 1, 2028

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).
January 29, 2026

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.
February 6, 2026

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.
February 11, 2026

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 8, 2026

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 7, 2026

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.
April 1, 2026

More Information

Terms related to this study

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.
  • SHF101-004A

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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