MedTrace Logo

CSI Percutaneous Ventricular Assist Device (pVAD) Second in Human Study

NCT05695716 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-01-17

No results posted yet for this study

Summary

The purpose of this study is to collect data on safety and device performance on the CSI pVAD System used to support hemodynamic stability during HR-PCIs 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
2023-04-05
Primary Completion
2023-07-17
Completion
2023-07-17
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 NCT05695716 on ClinicalTrials.gov