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Recruiting NCT07402239

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

No phase Interventional Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NOVAtria System, Control.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device NOVAtria System
    The NOVAtria System, therapeutic and monitoring device will be implanted at interatrial septum with minimally invasive cardiac catheterization procedure
  • Other Control
    Right heart catheterization and TEE

Primary outcome measures

  • Primary Safety endpoint [Time frame: 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]

Eligibility criteria

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:
  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 15 centers
  • Fuzhou University Affiliated Provincial Hospital — Fuzhou
  • The First Hospital of Lanzhou University — Lanzhou
  • Guangdong Provincial People's Hospital — Guangzhou
  • Guizhou Provincial People's Hospital — Guiyang
  • Fuwai Central China Cardiovascular Hospital — Zhengzhou
  • The Second Xiangya Hospital of Central South University — Changsha
  • Xiangya Hospital of Central South University — Changsha
  • The Second Affiliated Hospital of Nanchang University — Nanchang
  • … and 7 more centers

Identifiers

NCT: NCT07402239 · SHF101-004A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗