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NCT01708863 · ClinicalTrials.gov registry record
A Prospective Study of Patients With Hypoplastic Left Heart Syndrome (HLHS) Following Stage II Surgical Palliation
A clinical trial, sponsored by Timothy J Nelson, MD, PhD.
- Completed
- Registry status
- 4
- Enrollment target
NCT01708863 is a clinical trial that has completed, run by Timothy J Nelson, MD, PhD. The registered enrollment target is 4 participants.
The verdict
NCT01708863 has completed, sponsored by Timothy J Nelson, MD, PhD.
- COMPLETED
- Registry status
- 4 participants
- Enrollment target
Study Summary
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 patients.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2012-10 |
| Est. Completion | 2020-05-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01708863
The ClinicalTrials.gov registry entry for NCT01708863 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Timothy J Nelson, MD, PhD, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01708863 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01708863 about?
NCT01708863 is a clinical study titled "A Prospective Study of Patients With Hypoplastic Left Heart Syndrome (HLHS) Following Stage II Surgical Palliation". 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...
What is the current status of trial NCT01708863?
This trial is currently completed. The enrollment target is 4 participants. The study started on 2012-10. Estimated completion is 2020-05-15.
Who is sponsoring clinical trial NCT01708863?
This trial is sponsored by Timothy J Nelson, MD, PhD, which has 5 total clinical trials registered on ClinicalTrials.gov.
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