Not Yet RecruitingNot Applicable

A Prospective, Multicenter,Single-arm Study of DuoCor 2 Ventricular Assist System for the Treatment of Advanced Biventricular Heart Failure

China64 participantsStarted 2026-10

Plain-language summary

The objective of this clinical investigation is to evaluate the safety and efficacy of the DuoCor 2 Ventricular Assist System (DuoCor 2 VAS) in subjects with advanced biventricular heart failure requiring circulatory support. Each subject receiving the DuoCor 2 VAS will be evaluated at 6 months (180 days) for primary and secondary endpoints with further follow-up assessments up to 2 years.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 1.18 years ≤ Age ≤ 75 years * 2.INTERMACS Class 1-2 * 3.Patient is inotrope dependent, OR has a Cardiac Index (CI) \< 2.2 L/min/m2, while not on inotropes * 4\. Patient has reduced exercise capacity due to cardiac factors with at least one of the following criteria: * Unable to exercise * 6-minute walking test (6MWT) \< 300 meters * 5.Patient has right heart failure related symptoms such as lower limbs edema, jugular vein distension * 6.Patient has advanced, irreversible biventricular heart failure and is deemed to be eligible for biventricular mechanical circulatory support by clinical expertise. * 6a: advanced left heart failure * Left ventricular ejection fraction (LVEF) ≤ 30%; * Pulmonary capillary wedge pressure (PCWP) \> 15mmHg. * 6b: severe right heart failure despite guideline-directed medical therapy. This includes at least one evaluation index of right ventricular function and at least one evaluation index of volume load or structural abnormality: * Evaluation index of right ventricular function: * Right ventricular ejection fraction (RVEF)≤ 30%; * Right ventricular stroke work index (RVSWI)≤ 0.25 mmHg\*L/m2; * Right ventricle fractional area change(RVFAC) \< 30%; * Evaluation index of volume load or structural abnormality: * Central venous pressure (CVP)\> 15 mmHg; * CVP to PCWP ratio\> 0.63; * Moderate to severe tricuspid regurgitation; * Right ventricular (RV) to left ventricular (LV) end-diastolic diameter ratio\> 0.72; * T…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Event-free survival rate at 6 months post-implantation

Timeframe: 6 months

Trial details

NCT IDNCT07757451

SponsorShenzhen Core Medical Technology CO.,LTD.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-07

Contact for this trial

Lily Shi

+86 1341860135 shixiaoli@coretechmed.com

View on ClinicalTrials.gov More Advanced Heart Failure trials