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Clinical trial

A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial to Assess the Efficacy and Safety of the OmniHeart 4.0 Percutaneous Ventricular Assist Device for Hemodynamic Support in Patients Undergoing High-risk Percutaneous Coronary Intervention (PCI).

NCT07622446 is registered in ClinicalTrials.gov with Shanghai Dynaheart Medtech Co., Ltd. as lead sponsor.

NCT NCT07622446
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Registry record

As filed in ClinicalTrials.gov.

Title
A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial to Assess the Efficacy and Safety of the OmniHeart 4.0 Percutaneous Ventricular Assist Device for Hemodynamic Support in Patients Undergoing High-risk Percutaneous Coronary Intervention (PCI).
Lead sponsor
Shanghai Dynaheart Medtech Co., Ltd.
Phase
Not applicable
Overall status
Active, not recruiting
Start date
December 30, 2024
Completion date
December 31, 2026
Enrollment
254 (actual)
Sites
2

Conditions

As the registry lists them; a condition with its own page is linked.

high-risk pci