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

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: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: NOVAtria System; Other: Control

• Study Type: Interventional
• Enrollment (Estimated): 330
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: WANG Jian'an; Phone Number: +86 0571 87783759; Email: jiangbo@zju.edu.cn

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: United Innomed(Shanghai) Limited

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID 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