Status:
COMPLETED
Cardiovascular Systems Inc. (CSI) pVAD First in Human Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will collect initial clinical data on the CSI pVAD system to inform device design and finalization.
Eligibility Criteria
Inclusion
- Male or non- pregnant female ≥ 18 years of age
- Life expectancy ≥ 1 year
- Ejection Fraction (EF) \>15% and ≤ 40%
- Scheduled for an elective high risk percutaneous coronary intervention
Exclusion
- 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
- Pre-Procedure cardiac arrest within 24 hours of enrollment requiring cardiopulmonary resuscitation
- Cardiogenic shock
- Left ventricular (LV) mural thrombus
- Presence of a prosthetic valve or a heart constrictive device
- Aortic stenosis
- Moderate or severe aortic regurgitation (≥ 2+ by echo)
- 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
- Severe aortic tortuosity
- Severe aortic calcification
- Vasculature will not tolerate a right heart catheterization
- Renal dysfunction (serum creatinine ≥ 2.5 mg/dl) or requirement for hemodialysis
- 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
- Uncorrectable abnormal coagulation parameters
- History of heparin induced thrombocytopenia
- Sustained ventricular tachycardia
- Stroke or transient ischemic attack (TIA) within 6 months or any permanent neurological deficit
- Chronic anemia (hemoglobin \< 8 g/dL)
- Subject may require long term support with a commercially available hemodynamic support device
- Active systemic infection requiring oral or intravenous antibiotics
- Allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or antiplatelet therapy drugs that cannot be adequately premedicated
- Allergy or intolerance to system components
- Participation in another investigational drug or device study
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05315544
Start Date
March 14 2022
End Date
March 16 2022
Last Update
December 11 2023
Active Locations (1)
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1
Tbilisi Heart & Vascular
Tbilisi, Georgia