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Completed

NCT Number: NCT05315544

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

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tbilisi Heart & Vascular

Tbilisi, Georgia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

CSI pVAD system

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.

Primary outcomes

  1. Procedural success

    Time frame: Intraprocedural

    Delivery of the device to the correct anatomical position, successful operation and removal of the CSI pVAD system

  2. Intraprocedural Major Device-Related Adverse Events

    Time frame: 24-hours Post-Index Procedure

    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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 7, 2022
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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