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New treatment option for Heart Failure
Official title HARMONY Trial : To Evaluate a Therapeutic and Monitoring Device(NOVAtria System) for Heart Failure Management
ClinicalTrials.gov ID: NCT07402239
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Main ：
- 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
You likely can't join if
- Currently in an acute decompensation of chronic heart failure (hospitalization within 2 weeks prior to enrollment), refractory end-stage heart...
- 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...
- Coronary artery disease requiring revascularization;
- Hypertrophic cardiomyopathy, active myocarditis, cardiac tamponade or large pericardial effusion, congenital heart disease, or other causes of heart...
See the full eligibility criteria
- Main ：
- 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...
- Able to perform 6-minute walk test (6MWT), with a distance between 100 meters and 450 meters Main
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Guiyang, Guizhou, China
- Zhengzhou, Henan, China
- Changsha, Hunan, China
- Nanchang, Jiangxi, China
- Shanghai, Shanghai Municipality, China
- Xi’an, Shanxi, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
- Ningbo, Zhejiang, China
- Wenzhou, Zhejiang, China
- Chengdu, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Lanzhou, Gansu, China; Guangzhou, Guangdong, China; Guiyang, Guizhou, China; Zhengzhou, Henan, China; Changsha, Hunan, China and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.