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

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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: CSI pVAD system

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Georgia
  • Tbilisi, Georgia
    • Tbilisi Heart & Vascular

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CSI pVAD	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	Delivery of the device to the correct anatomical position, successful operation and removal of the CSI pVAD system	Intraprocedural
Intraprocedural Major Device-Related Adverse Events	Composite incidence of: Cardiovascular death; Clinically significant myocardial infarction (MI) defined as the composite of MI events per Society for Cardiovascular Angiography and Intervention (SCAI) periprocedural MI and Fourth Universal MI definitions; Any repeat revascularization (PCI or CABG); Stroke defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.	24-hours Post-Index Procedure

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Collaborators: Clinical Accelerator
• Investigators: Study Director: Jeff Chambers, MD, Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Actual): March 16, 2022
• Study Completion (Actual): March 16, 2022

Study Registration Dates

• First Submitted: March 26, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: pVAD; High risk PCI; Cardiovascular Systems, Inc.; Mechanical Circulatory Support (MCS)
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: CLN-0015-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes