HARMONY Trial : To Evaluate a Therapeutic and Monitoring... | NCT07402239

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
NOVAtria System	Device	The NOVAtria System, therapeutic and monitoring device will be implanted at interatrial septum with minimally invasive cardiac catheterization procedure	Roll in

Outcomes Module

Primary Outcomes

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

Eligibility Module

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:
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

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases