Catheter-Oriented Unloading and Recovery With a Left Ventricular Assist Gear: Efficacy in Post Cardiotomy Cardiogenic Shock

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorForQaly Medical (Shanghai) Co., Ltd

About this trial

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.

Eligibility criteria

Qualifiers

18≤Age≤80, any sex.

Failure to wean from CPB or refractory cardiogenic shock after cardiac surgery.

Disqualifiers

Body surface area>2.5m2.

Presence of any cardiac assist device (other than an IABP).

Right ventricular failure.

Evidence of any vascular disease or anatomy precluding placement or deployment of the device (e.g. severely calcified vessel).

Trial design

Treatments tested in this trial

  • SynFlow Duro

Treatment groups

60 Participants
are divided into 1 treatment group