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

NCT07402239 | Recruiting

• 1 other identifier: SHF101-004A
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 15

Brief 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 Class III who at baseline are treated with guideline-directed drug and device therapies.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

  30-days after randomization

• 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

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

Study Arms (3)

Treatment

EXPERIMENTAL

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

Control

OTHER

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

Roll in

EXPERIMENTAL

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

Interventions

NOVAtria System DEVICE

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

Roll in; Treatment

Control OTHER

Right heart catheterization and TEE

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• At least one hospitalization for heart failure within the past 12 months;
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• United Innomed(Shanghai) Limited: lead

Study Sites (15)

Fuzhou University Affiliated Provincial Hospital

Fuzhou, Fujian, China

NOT YET RECRUITING

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

NOT YET RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

NOT YET RECRUITING

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

NOT YET RECRUITING

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

NOT YET RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

NOT YET RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, China

NOT YET RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

NOT YET RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Xijing Hospital

Xi’an, Shanxi, China

NOT YET RECRUITING

West China Hospital

Chengdu, Sichuan, China

NOT YET RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medcine

Hangzhou, Zhejiang, China

RECRUITING

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

NOT YET RECRUITING

The First AFfiliated Hospital of MWU

Wenzhou, Zhejiang, China

NOT YET RECRUITING

Sichuan Provincial People's Hospital

Chengdu, China

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

WANG Jian'an

CONTACT

+86 0571 87783759; jiangbo@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 11, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-04

Locations

CN (15)