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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05315544
• Other study ID #: CLN-0015-P
• Status: Completed
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: March 16, 2022

Study information

• Verified date: December 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 16, 2022
• Est. primary completion date: March 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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.

Locations

Country	Name	City	State
Georgia	Tbilisi Heart & Vascular	Tbilisi

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural success	Delivery of the device to the correct anatomical position, successful operation and removal of the CSI pVAD system	Intraprocedural
Primary	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