PULsecath mechanicaL Support Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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

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Coronary Artery Disease Heart Failure Cardiogenic Shock

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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iVAC2L pVAD

Clinically indicated ventricular support for high-risk PCI with Pulsecath iVAC2L.

Group Type EXPERIMENTAL

iVAC2L pVAD

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patient is ≥ 18 years;
2. Informed Consent must be signed by the patient, prior to HR-PCI;
3. The multidisciplinary heart team has reached consensus for high-risk PCI. Patients may present with left ventricular systolic dysfunction (ejection fraction ≤40%);
4. Anatomical criteria: Intervention to an unprotected left main coronary artery, left main equivalent or single remaining vessel; multivessel disease; intervention in a distal left main bifurcation.

Exclusion Criteria

1. No written informed consent;
2. Left ventricular thrombus;
3. Interventricular septal defect;
4. Significant peripheral arterial disease or arterial lumen size \< 6mm at the level of the common femoral artery;
5. Significant aortic valve disease (more than mild aortic stenosis/regurgitation);
6. Cardiogenic shock;
7. Previous stroke within the last 3 months;
8. Major bleeding event within last 3 months;
9. Chronic kidney disease with a GFR \< 25 mL/min;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No