Single Ventricle Outcome

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-30

Study Completion Date

2005-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this research proposal is to perform an ongoing single institution prospective clinical trial examining the overall clinical outcome of children with single ventricle physiology.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Congenital disease is the most common cause for infant death from a birth defect. Approximately 30,000 infants are born each year with congenital heart defects.Over one-third of those babies will require cardiac surgery. A particularly lethal cardiac defect is one with single ventricle physiology. The objective of this research proposal is to perform an ongoing single institution prospective clinical trial examining the overall clinical outcome of children with single ventricle physiology.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Disease, Congenital Single Ventricle Hypoplastic Left Heart Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Heart Disease, Congenital Single Ventricle Hypoplastic Left Heart Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All patients with single ventricle physiology scheduled for ultimate Fontan surgical palliation at Children's Healthcare of Atlanta will be eligible.
* All subjects must sign informed consent prior to enrollment in study.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Robert Campbell, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert M Campbell, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, Emory University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0604-2005

Identifier Type: -

Identifier Source: org_study_id