Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00308217
Other study ID # 0604-2005
Secondary ID
Status Completed
Phase N/A
First received March 27, 2006
Last updated December 11, 2013
Start date June 2005
Est. completion date June 2005

Study information

Verified date December 2013
Source Emory University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Time Perspective: Prospective


Locations

Country Name City State
United States Children's Healthcare of Atlanta Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Emory University

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Completed NCT01215240 - Prophylactic Peritoneal Dialysis Decreases Time to Achieve a Negative Fluid Balance After the Norwood Procedure N/A
Completed NCT00513240 - Erythropoetin Neuroprotection for Neonatal Cardiac Surgery Phase 1/Phase 2
Withdrawn NCT00156455 - Sleep Disordered Breathing in Children With Single Ventricle Physiology N/A
Terminated NCT01445041 - Safety and Feasibility Study of Umbilical Cord Blood Cells for Infants With Hypoplastic Left Heart Syndrome Phase 1
Recruiting NCT04581668 - Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart Disease N/A
Completed NCT01708863 - A Prospective Study of Patients With Hypoplastic Left Heart Syndrome (HLHS) Following Stage II Surgical Palliation
Completed NCT01736956 - Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome N/A
Recruiting NCT03406884 - The CHILD Trial: Hypoplastic Left Heart Syndrome Study. Phase 1
Not yet recruiting NCT06461676 - Study of Intramyocardial Injection of Ventrix Bio Extracellular Matrix (VentriGel) to Assess the Safety and Feasibility in Pediatric Patients With Hypoplastic Left Heart Syndrome (HLHS) Phase 1
Active, not recruiting NCT03079401 - Mesoblast Stem Cell Therapy for Patients With Single Ventricle and Borderline Left Ventricle Phase 1/Phase 2
Completed NCT02306057 - Fluid Balance in Children Undergoing Fontan Surgery N/A
Terminated NCT01107990 - Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques
Completed NCT01883076 - Safety Study of Autologous Umbilical Cord Blood Cells for Treatment of Hypoplastic Left Heart Syndrome Phase 1
Completed NCT04056416 - Physical Activity Promotion in Children and Adolescents With Single Ventricle Physiology (MedBike) N/A
Completed NCT01656941 - Genetic Determinants of Congenital Heart Disease Outcomes
Completed NCT00464100 - Near-infrared Spectroscopy (NIRS) Neurodevelopmental Outcomes
Active, not recruiting NCT03779711 - Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome Phase 2
Recruiting NCT04925024 - Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS): A Phase IIb Clinical Trial. Phase 2
Recruiting NCT02781922 - Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial) Phase 3
Completed NCT01582529 - SVRII Family Factors Study