A Prospective Study of Patients With Hypoplastic Left Heart Syndrome (HLHS) Following Stage II Surgical Palliation
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|ClinicalTrials.gov Identifier: NCT01708863|
Recruitment Status : Unknown
Verified March 2016 by Timothy J. Nelson, Mayo Clinic.
Recruitment status was: Recruiting
First Posted : October 17, 2012
Last Update Posted : March 15, 2016
Hypoplastic left heart syndrome (HLHS) is a severe form of congenital heart disease that consists of multiple obstructions to flow through the left heart and aorta, as well as hypoplasia of the left ventricle. Most patients require a three-stage surgical protocol starting within days of birth. Stage I of this process is the Norwood reconstruction (within the first few days of life), Stage II (usually required within 3-8 months) involves creation of a direct connection between the patient's superior vena cava and the pulmonary arterial confluence (bidirectional Glenn anastomosis), and the last stage is creation of a Fontan circulation (typically within the first 2-4 years). This "single ventricle" approach requires the right ventricle to perform as the only circulatory pump for the entire body.
Our long-term goal is to develop regenerative strategies to strengthen and augment the right ventricular muscle of the single-ventricle heart following surgical palliation in HLHS patients. To determine the safety and feasibility of a cell-based therapeutic intervention at the Stage II surgery, we aim to document the natural history of post-surgical care in HLHS patients having undergone standard of care with protocol specific follow-up over the course of a 6-month period.
This prospective study will document the natural history in patients with HLHS after planned Stage II surgical palliation with a focus on cardiovascular parameters within 6 months following surgery in 10-20 patients.
|Condition or disease|
|Hypoplastic Left Heart Syndrome|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||A PROSPECTIVE STUDY OF PATIENTS WITH HYPOPLASTIC LEFT HEART SYNDROME FOLLOWING STAGE II SURGICAL PALLIATION|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||January 2017|
Children with Hypoplastic Left Heart Syndrome (HLHS)
HLHS patients requiring Stage II Glenn surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708863
|Contact: Karen S Millerfirstname.lastname@example.org|
|Contact: Karen M Cavanaughemail@example.com|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55901|
|Contact: Karen S Miller 507-266-5510 firstname.lastname@example.org|
|Contact: Karen M Cavanaugh 507-538-8425 email@example.com|
|Principal Investigator: Muhammad Y Qureshi, MBBS|
|United States, Oklahoma|
|Oklahoma University Children's Hospital||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Stephanie Mitchell 405-271-2128 firstname.lastname@example.org|
|Contact: Nicholas Farley 405-271-4411 ext 44403 email@example.com|
|Principal Investigator: Harold M Burkhart, M.D.|
|Study Director:||Timothy J Nelson, MD, PhD||Mayo Clinic|
|Principal Investigator:||Muhammad Y Qureshi, MBBS||Mayo Clinic|