Heart Failure
Conditions
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.
Interventions
DEVICENOVAtria System
The NOVAtria System, therapeutic and monitoring device will be implanted at interatrial septum with minimally invasive cardiac catheterization procedure
OTHERControl
Right heart catheterization and TEE
Sponsors
United Innomed(Shanghai) Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety endpoint | 30-days after randomization | 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 |
| Composite Primary Effective endpoint | Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months | 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 |
Countries
China
Contacts
CONTACTWANG Jian'an
Outcome results
None listed