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

NCT ID: NCT05315544

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-14

Study Completion Date

2022-03-16

Brief Summary

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

Detailed Description

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Conditions

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Coronary Artery Disease

Keywords

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pVAD High risk PCI Cardiovascular Systems, Inc. Mechanical Circulatory Support (MCS)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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CSI pVAD

Group Type EXPERIMENTAL

CSI pVAD system

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Male or non- pregnant female ≥ 18 years of age
2. Life expectancy ≥ 1 year
3. Ejection Fraction (EF) \>15% and ≤ 40%
4. Scheduled for an elective high risk percutaneous coronary intervention

Exclusion Criteria

1. Hemodynamically unstable MI with elevated cardiac biomarker and no evidence of at least 1 consecutive CK-MB or troponin value trending downward from a previous value OR ST-Elevation Myocardial Infarction (STEMI) within 14 days of Index Procedure
2. Pre-Procedure cardiac arrest within 24 hours of enrollment requiring cardiopulmonary resuscitation
3. Cardiogenic shock
4. Left ventricular (LV) mural thrombus
5. Presence of a prosthetic valve or a heart constrictive device
6. Aortic stenosis
7. Moderate or severe aortic regurgitation (≥ 2+ by echo)
8. Severe peripheral vascular disease that will preclude the use of a 12F access sheath, which is required for the insertion of the CSI pVAD catheter
9. Severe aortic tortuosity
10. Severe aortic calcification
11. Vasculature will not tolerate a right heart catheterization
12. Renal dysfunction (serum creatinine ≥ 2.5 mg/dl) or requirement for hemodialysis
13. Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3X upper lab normal (ULN) or Internationalized Normalized Ratio (INR) ≥ 2 or lactate dehydrogenase (LDH) \> 2.5X ULN
14. Uncorrectable abnormal coagulation parameters
15. History of heparin induced thrombocytopenia
16. Sustained ventricular tachycardia
17. Stroke or transient ischemic attack (TIA) within 6 months or any permanent neurological deficit
18. Chronic anemia (hemoglobin \< 8 g/dL)
19. Subject may require long term support with a commercially available hemodynamic support device
20. Active systemic infection requiring oral or intravenous antibiotics
21. Allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or antiplatelet therapy drugs that cannot be adequately premedicated
22. Allergy or intolerance to system components
23. Participation in another investigational drug or device study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeff Chambers, MD

Role: STUDY_DIRECTOR

Abbott Medical Devices

Locations

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Tbilisi Heart & Vascular

Tbilisi, , Georgia

Site Status

Countries

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Georgia

Other Identifiers

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CLN-0015-P

Identifier Type: -

Identifier Source: org_study_id