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Heart FailureNCT07402239

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

A study testing NOVAtria System in people with Heart Failure, run by United Innomed(Shanghai) Limited at 15 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… 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?
NOVAtria System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
15 sitesChina
Study dates
16 Mar 2026to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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

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

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

WANG Jian'an contact

+86 0571 87783759

jiangbo@zju.edu.cn

15 sites in 1 country

China15 sites, 15 recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

    FANG Zhenfei

    Not yet recruiting

  • Xiangya Hospital of Central South University

    Changsha, Hunan

    BAI Yongping

    Not yet recruiting

  • West China Hospital

    Chengdu, Sichuan

    CHEN Mao

    Not yet recruiting

  • Sichuan Provincial People's Hospital

    Chengdu

    ZENG Jie

    Not yet recruiting

  • Fuzhou University Affiliated Provincial Hospital

    Fuzhou, Fujian

    GUO Yansong

    Not yet recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

    JING Zhicheng

    Not yet recruiting

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou

    WU Qiang

    Not yet recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medcine

    Hangzhou, Zhejiang

    WANG Jian'an, +86 0571 87783759

    Recruiting

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu

    BAI Ming

    Not yet recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    YANG Renqiang

    Not yet recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang

    CHEN Xiaomin

    Not yet recruiting

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality

    LI Ruogu

    Not yet recruiting

  • The First AFfiliated Hospital of MWU

    Wenzhou, Zhejiang

    ZHOU Hao

    Not yet recruiting

  • Xijing Hospital

    Xi’an, Shanxi

    TAO Ling

    Not yet recruiting

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou, Henan

    YUAN Yiqiang

    Not yet recruiting

Other trials in China

About this study

Official title: 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.

Conditions
Heart Failure
Being tested
NOVAtria System, Control
Medical subject headings
Heart Failure

What participants receive

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

  • NOVAtria SystemDevice

    The NOVAtria System, therapeutic and monitoring device will be implanted at interatrial septum with minimally invasive cardiac catheterization procedure

  • ControlOther

    Right heart catheterization and TEE

Study groups in NCT07402239
Study groupRoleWhat they receive
TreatmentExperimentalTreatment 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
Receives: Device: NOVAtria System
ControlOtherControl 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
Receives: Other: Control
Roll inExperimentalRoll 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
Receives: Device: NOVAtria System

What is being measured

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

  1. Primary Safety endpoint

    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

    Measured: 30-days after randomization

  2. Composite Primary Effective endpoint

    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

    Measured: Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months

Timeline

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

  1. First posted11 Feb 2026
  2. Study start16 Mar 2026
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07402239
Sponsor's protocol ID
SHF101-004A
Status last verified
Apr 2026
First submitted
29 Jan 2026
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing NOVAtria System in people with Heart Failure, run by United Innomed(Shanghai) Limited at 15 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?

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: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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?

This study is still under way. Results are not available in the source record yet.

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

Contact WANG Jian'an (+86 0571 87783759, jiangbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety endpoint (time frame: 30-days after randomization). The study lists 2 primary outcomes in all. 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 NCT07402239.

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 8 May 2026.

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