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PULsecath mechanicaL Support Evaluation

NCT03200990 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-03-29

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Nicolas v. Mieghem, MD, PhD · Erasmus Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • France
  • Netherlands
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03200990 on ClinicalTrials.gov