HARMONY Trial : To Evaluate a Therapeutic and Monitoring Device(NOVAtria System) for Heart Failure Management
Recruiting
N/A
Interventional Study
Heart Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 330 (estimated)
- Sponsor
- United Innomed(Shanghai) Limited · Industry
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About This Trial
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 therapi…
Trial Locations
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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) funct…
Contacts