A Prospective Study of Patients with Hypoplastic Left Heart Syndrome (HLHS) Following Stage II Surgical Palliation

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 12-002887
    NCT ID: NCT01708863
    Sponsor Protocol Number: 12-002887

About this study

The purpose of this study is to determine the change in health outcomes and cardiac structure and function of subjects with HLHS following successful separation from cardiopulmonary bypass and reversal of anticoagulation at the time of elective Stage II Glenn surgical palliation.

 

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Individuals with HLHS having undergone Stage I surgical palliation and undergoing planned Stage II palliative Glenn surgery.
  • Individuals up to 18 months of age are eligible if written informed consent can be obtained from both parents and/or legal guardians, unless one parent is not reasonably available.

Exclusion Criteria:

  • Parent(s)/child unwilling to participate.
  • Child with severe chronic diseases, extensive extra-cardiac syndromic features, or history of cancer.
  • Child has not completed or will not be completing all pre-procedure work-up within 10 days of the Stage II Glenn surgery as listed in section 5 of this protocol AND lack of pre-procedure work-up documented as a safety concern by a site investigator.
  • Child with the following complications of their congenital heart disease:
    • Any condition requiring urgent, or unplanned procedure within 15 days prior to Stage II surgical repair;
    • Severe pulmonary hypertension (reported in the medical record as >70% systemic pressure); and
    • Other clinical concerns as documented by a site investigator that would predict (more likely to happen than not to happen) a risk of severe complications or very poor outcome during or after Stage II surgical repair.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

M. Yasir Qureshi, M.B.B.S.

Open for enrollment

Contact information:

Karen Miller CCRP

(507)266-5510

Miller.Karen1@mayo.edu

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CLS-20119380

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