Shenzhen Core Medical opens 6-patient trial of percutaneous right-heart pump
The device-feasibility study will test whether CorVad can support patients in refractory right heart failure through explant, with survival as the primary measure.
Executive Summary
- A device maker opened a small feasibility study of a percutaneous right-heart pump in patients whose right heart failure has not responded to standard drug therapy after major cardiac procedures.
- The study is built around survival through device explant or transition to longer-term therapy, a hard clinical endpoint rather than a surrogate, in a population defined by strict hemodynamic and echocardiographic criteria.
- Percutaneous right-heart support has few direct device peers in current testing; the surrounding right heart failure field is dominated by pharmacologic programs testing different mechanisms entirely, and the trial's differentiation rests on delivery route rather than a novel drug target.
- The trial's operational footing looks unremarkable so far, and the real test is whether a handful of patients can produce a signal precise enough to support a larger, controlled follow-on study.
The trial
The study, registered as NCT07704424, opened for recruitment on June 2, 2026, and targets 6 patients across sites in China. It is classified as Not Applicable phase, the standard designation for device feasibility studies rather than a drug-development phase, and it is not registrational. The primary completion date is set for December 31, 2026, with full study completion anticipated by February 28, 2027. NCT07704424Safety and Feasibility of the CorVad Percutaneous Ventricular Assist System in Refractory Right Heart FailureNCT07704424
The endpoint bar
The primary outcome is survival rate, measured to 30 days after device explant or hospital discharge, whichever is longer, or through the start of a longer-term therapy such as heart transplant or a surgical right ventricular assist device. Secondary measures track changes in cardiac index and central venous pressure at 24 hours of support, along with major bleeding, hemolysis, pulmonary embolism, and valve dysfunction through 30 days post-explant. Entry requires a cardiac index under 2.2 L/min/m² despite high-dose inotropes or vasopressors, plus elevated central venous pressure or echocardiographic evidence of moderate-to-severe right ventricular dysfunction, criteria designed to isolate a population that has already failed standard drug therapy. NCT07704424Safety and Feasibility of the CorVad Percutaneous Ventricular Assist System in Refractory Right Heart FailureNCT07704424
The population
The study excludes the most unstable patients: those in INTERMACS Stage 1, defined by persistent hypotension and organ hypoperfusion despite inotropes or temporary mechanical support, are not eligible. That exclusion, combined with the inclusion bar, points to a target population that is failing medical therapy but has not yet progressed to the point where mechanical circulatory support becomes an emergency intervention, the window where a percutaneous device might add the most value. NCT07704424Safety and Feasibility of the CorVad Percutaneous Ventricular Assist System in Refractory Right Heart FailureNCT07704424
Competitive field
Right heart failure trials currently in the field are concentrated in pharmacology: Merck's vericiguat, AstraZeneca's baxdrostat, Bayer's finerenone, and Boehringer Ingelheim's vicadrostat are each testing distinct drug mechanisms in heart failure populations, none of them percutaneous right-heart devices. The nearest modality neighbors identified are cell-therapy programs for heart failure broadly, including HELP Therapeutics' HiCM-188 cardiomyocyte injection programs and Rohto Pharmaceutical's ADR-002K, but none share CorVad's percutaneous mechanical-support approach or its right heart failure population specifically. The molecular target underlying CorVad's mechanism is not characterized in the trial record, so this comparison rests on modality and indication rather than a specific target.
Sponsor track record
Shenzhen Core Medical Technology carries a broader pipeline of 9 trials across recruiting, completed, and not-yet-recruiting stages, and its 2 prior heart failure trials both completed. That is a small sample, but it is a clean one, with no terminations on record in the therapeutic areas covered by its portfolio. Protocol activity on this specific study has been limited to the initial registration, and the registry has logged no primary-completion-date slippage since the trial only opened for enrollment on June 2, 2026. NCT07704424Safety and Feasibility of the CorVad Percutaneous Ventricular Assist System in Refractory Right Heart FailureNCT07704424
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.