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Cardiovascular Systems Inc. (CSI) pVAD First in Human Study

NCT05315544 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-12-11

No results posted yet for this study

Summary

This study will collect initial clinical data on the CSI pVAD system to inform device design and finalization.

Conditions

Interventions

DEVICE

CSI pVAD system

The CSI percutaneous ventricular assist device (pVAD) is being investigated as a temporary left ventricular system intended to support and/or provide hemodynamic stability during high-risk percutaneous coronary interventions.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Jeff Chambers, MD · Abbott Medical Devices

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-14
Primary Completion
2022-03-16
Completion
2022-03-16
FDA Device
Yes

Countries

  • Georgia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05315544 on ClinicalTrials.gov