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

NCT05315544 | Completed FDA Device

• 1 other identifier: CLN-0015-P
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

CSI pVAD

EXPERIMENTAL

Device: CSI pVAD system

Interventions

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.

CSI pVAD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Tbilisi Heart & Vascular

Tbilisi, Georgia

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Jeff Chambers, MD

  Abbott Medical Devices

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2022
• First Posted: April 7, 2022
• Study Start: March 14, 2022
• Primary Completion: March 16, 2022
• Study Completion: March 16, 2022
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1)