NCT03200990

PULsecath mechanicaL Support Evaluation

PULsecath mechanicaL Support Evaluation (PULSE) - Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine ventricular loading conditions during and after PulseCath® iVAC2L support, and assess its impact on specific load dependent humoral factors and cardiac enzymes. These specific patterns are so far unknown and will be evaluated invasively.

Detailed description

This is a mechanistic exploratory study. The objective is to determine the effects of the new PFLVAD PulseCath® iVAC2L on ventricular loading using left ventricular pressure-volume loops, in association with systemic and pulmonary hemodynamic parameters obtained from right and left catheterization. Additionally, assessments of specific load and flow-dependent humoral factors and cardiac enzymes will be made during and after the use of mechanical circulatory support. These specific patterns are so far unknown. Knowledge of optimal patterns may help in determining the ideal circulatory device platform.

Conditions

• Coronary Artery Disease
• Heart Failure
• Cardiogenic Shock

Interventions

Type	Name	Description
DEVICE	iVAC2L pVAD	To determine the effects of the new PFLVAD PulseCath® iVAC2L on ventricular loading using left ventricular pressure-volume loops, in association with systemic and pulmonary hemodynamic parameters obtained from right and left catheterization. Additionally, assessments of specific load and flow-dependent humoral factors, and cardiac enzymes, will be made during and after the use of mechanical circulatory support.

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2017-06-28
• Last updated: 2021-03-29

Locations

3 sites across 3 countries: France, Netherlands, United Kingdom