WithdrawnNot Applicable

A Safety and Effectiveness Study of the Supira System in Patients Undergoing HRPCI - CE Study

Stopped: Study was never submitted to any Ethics Committee, Competant Authorities or any regulatory body. It was decided to cancel the study and not to proceed.

0Started 2024-01

Plain-language summary

The objective of this study is to evaluate the safety and effectiveness of utilizing the Supira System to provide hemodynamic support during HRPCI.

Who can participate

Age range18 Years – 90 Years

SexALL

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Inclusion criteria

✓. Age ≥18 years and ≤90 years
✓. Hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is deemed necessary as determined by the institutional Heart Team.
✓. Informed consent granted by the patient or legally authorized representative

Exclusion criteria

✕. Cardiogenic shock or acutely decompensated pre-existing chronic heart failure a. Note: Cardiogenic shock is defined as: systemic hypotension (systolic blood pressure \[BP\] \<90 mmHg or the need for inotropes/pressors to maintain a systolic BP \>90 mmHg) plus one of the following: any requirement for inotropes/pressors prior to arrival at the catheterization laboratory, clinical evidence of end-organ hypoperfusion or use of IABP or any other circulatory support device at time of screening.
✕. Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
✕. Evidence of left ventricular thrombus as assessed by Transthoracic Echocardiogram (TTE)
✕. Aortic valvular disease or regurgitation categorized as moderate or greater (≥ 2+ on a 4-grade scale as assessed on TTE)
✕. Aortic valve stenosis categorized as moderate or greater (gradient \>20 mmHg or valve area \<1.5 cm2 as assessed on TTE)
✕. Previous aortic valve replacement or repair
✕. Ascending or descending aortic dissection or aortic aneurysm \>4.5 cm
✕. Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the investigational device

What they're measuring

Successful initiation and maintenance of hemodynamic support

Timeframe: 90 days from procedure

Trial details

NCT IDNCT06565039

SponsorSupira Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09

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