Catheter-Oriented Unloading and Recovery With a Left Ventricular Assist Gear: Efficacy in Post Cardiotomy Cardiogenic Shock
NCT07560085 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-05-11
Summary
This study is a prospective, multicenter, single-arm clinical trial conducted in China to evaluate the efficacy and safety of a novel left ventricular assist device, SynFlow Duro system, manufactured by ForQaly Medical in the treatment of post cardiotomy cardiogenic shock.
Conditions
- Cardiogenic Shock
Interventions
- DEVICE
-
SynFlow Duro
a novel micro-axial flow pump for temporary left ventricular assistance
Sponsors & Collaborators
-
ForQaly Medical (Shanghai) Co., Ltd
lead INDUSTRY
Principal Investigators
-
Liangwan Chen · Fujian Medical University Union Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-31
- Primary Completion
- 2027-06-30
- Completion
- 2027-06-30
Countries
- China
Study Locations
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