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WithdrawnNCT02027350Updated Nov 4, 2016

New Methods to Diagnose Constrictive Pericarditis

An interventional study of CD Leycom/Millar Instruments conductance catheter in Constrictive Pericarditis, sponsored by Mayo Clinic. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-04.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic

Why this study was withdrawn
due lack of subjects
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

Until now, diagnosis of constriction was based on pressure changes of ventricle by conventional pressure-wide hemodynamic evaluation but not on ventricular volume change. This study will provide answers to persisting questions about volume changes during respiration in patients with constrictive pericarditis by directly measuring both right and left ventricular volume.

02

Conditions studied

  • Constrictive Pericarditis

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Subjects referred for right and left heart catheterization will be eligible.

04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Pressure-volume relationship

    Changes in pressure-volume relationships will be compared to changes in LV and RV systolic pressure during respiration.

    Device: CD Leycom/Millar Instruments conductance catheter

Interventions

  • DeviceCD Leycom/Millar Instruments conductance catheter

    Conductance catheter-Pressure volume relationship

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What researchers measure

Primary outcomes

  1. Presence of constrictive pericarditis

    Time frame: 1 hour

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Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
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Registry details

Key details

Study ID
NCT02027350
Lead sponsor
Mayo Clinic
Responsible party
Barry Borlaug (Associate Professor of Medicine, Mayo Clinic) — Principal investigator
First posted
Jan 6, 2014
Start date
Dec 2013
Primary completion
Nov 2015
Completion
Nov 2015
Last update
Nov 4, 2016

Study contacts

Barry Borlaug, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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