Actively Recruiting
HARMONY Trial : To Evaluate a Therapeutic and Monitoring Device(NOVAtria System) for Heart Failure Management
Led by United Innomed(Shanghai) Limited · Updated on 2026-05-08
330
Participants Needed
15
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
HARMONY Trial : To Evaluate a Therapeutic and Monitoring Device(NOVAtria System) for Heart Failure Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinically diagnosed with chronic heart failure
- Receiving guideline directed medical and device therapy for heart failure
- Left ventricular ejection fraction (LVEF) 40% or less assessed by echocardiography
- New York Heart Association (NYHA) functional class II or III
- For NYHA III, at least one hospitalization for heart failure within the past 12 months or elevated BNP/NT-proBNP levels within 3 months prior to enrollment
- Able to perform 6-minute walk test with a distance between 100 and 450 meters
You will not qualify if you...
- Acute decompensation of chronic heart failure or hospitalization within 2 weeks prior to enrollment
- Refractory end-stage heart failure or on waiting list for heart transplantation including LVAD
- Body mass index (BMI) greater than 40 or less than 18.5 kg/m2
- Systolic blood pressure less than 90 or greater than or equal to 160 mmHg
- Moderate or severe aortic or mitral stenosis or planned surgery for severe valve regurgitation
- Coronary artery disease requiring revascularization
- Hypertrophic cardiomyopathy, active myocarditis, cardiac tamponade, large pericardial effusion, congenital heart disease, or other causes of heart failure
- History of stroke, transient ischemic attack, deep vein thrombosis, or pulmonary embolism within past 3 months
- Severe chronic lung disease requiring oxygen or long-term corticosteroids
- Surgery involving atrial septal puncture within 3 months before enrollment
- Significant right ventricular dysfunction
- Estimated glomerular filtration rate (eGFR) less than 25 ml/min/1.73 m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Fuzhou University Affiliated Provincial Hospital
Fuzhou, Fujian, China
Not Yet Recruiting
2
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Not Yet Recruiting
3
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Not Yet Recruiting
4
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Not Yet Recruiting
5
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
6
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Not Yet Recruiting
7
Xiangya Hospital of Central South University
Changsha, Hunan, China
Not Yet Recruiting
8
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
9
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
10
Xijing Hospital
Xi’an, Shanxi, China
Not Yet Recruiting
11
West China Hospital
Chengdu, Sichuan, China
Not Yet Recruiting
12
The Second Affiliated Hospital Zhejiang University School of Medcine
Hangzhou, Zhejiang, China
Actively Recruiting
13
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Not Yet Recruiting
14
The First AFfiliated Hospital of MWU
Wenzhou, Zhejiang, China
Not Yet Recruiting
15
Sichuan Provincial People's Hospital
Chengdu, China
Not Yet Recruiting
Research Team
W
WANG Jian'an
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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