PV Loop & Coarctation Study

NCT ID: NCT05362721

Last Updated: 2025-03-24

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

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-04

Study Completion Date

2026-12-31

Brief Summary

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Coarctation of the aorta accounts for 4-7% of all congenital heart disease. While stent therapy, when feasible, is the standard of care for coarctation, it may not completely improve the work (and afterload) of the heart due to its effects on the elasticity of the aorta. This study will provide the information needed to understand the effects of current management on the cardiac mechanics and work.

Detailed Description

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Conditions

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Coarctation of Aorta

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pressure-volume loop catheter

Pressure-volume loop catheter

Intervention Type DIAGNOSTIC_TEST

The cardiac catheterization procedure will be done according to standard protocol as part of the standard clinical care. This has become the standard of care in any patient in which it feasible and is performed with low risk.

Interventions

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Pressure-volume loop catheter

The cardiac catheterization procedure will be done according to standard protocol as part of the standard clinical care. This has become the standard of care in any patient in which it feasible and is performed with low risk.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Children 6 years of age and older and adults of all races and both sexes referred for elective cardiac catheterization and stent therapy for coarctation
* Those who provide informed consent for study participant.

Exclusion Criteria

* Children who undergo other interventions in addition to the coarctation
* Children with single ventricle physiology.
* Renal impairment
* Participant unwilling to sign a consent form.
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gurumurthy Hiremath

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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Children's Hospital of Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Children's Hospital of Boston

Boston, Massachusetts, United States

Site Status RECRUITING

Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States

Site Status RECRUITING

University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status RECRUITING

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Site Status RECRUITING

University of Texas-Southwestern

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Brittany Faanes

Role: CONTACT

612-625-5929

Facility Contacts

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Neil Patel

Role: primary

Nikhil Thatte, MD

Role: primary

Oliver Aregullin, MD

Role: primary

616-267-9150

Brittany Faanes

Role: primary

612-625-5929

Toby Rockefeller, MD

Role: primary

Sarosh (Shawn) Batlivala, MD

Role: primary

513-636-4432

Suren Reddy

Role: primary

Other Identifiers

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PEDS-2019-27404

Identifier Type: -

Identifier Source: org_study_id

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