Devitalized Non-Valved Pulmonary Artery Allograft Implant for the Repair of Congenital Cardiac Abnormalities - Full Text View

Purpose

This study is being undertaken as a confirmatory study to evaluate the safety and efficacy of the LifeNet Devitalized Non-valved Pulmonary Artery Allograft. This implant will aid in the reconstruction or repair of congenital heart defects.

Study results with this implant will be compared to historical control data that is derived from pediatric patients who have received a cryopreserved non-valved pulmonary artery allograft, which is the current standard of care.

Patient follow-up will be conducted at 3 months, 6 months, and 12 months. At all three time points, patients will be given a physical examination. Chest x-rays, echocardiograms (ultrasound of the heart), and blood samples will be taken at each visit as well.

Condition	Intervention
Congenital Cardiac Abnormality	Device: Devitalized Non-valved Pulmonary Artery Allograft

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Clinical Evaluation of Devitalized Non-Valved Pulmonary Artery Allografts Used in the Repair of Congenital Cardiac Abnormalities

Further study details as provided by LifeNet Health:

Primary Outcome Measures:

Determination of stenosis
Determination of dilation towards aneurysm
Serious adverse events attributable to the graft
Determination of device structural integrity
Determination of calcification of the graft proper

Secondary Outcome Measures:

Determination of Panel Reactive Antibody (PRA) formation
Determination of thromboembolism
Determination of bleeding events handled medically
Determination of bleeding events handled operatively
Determination of infection

Estimated Enrollment:

50

Eligibility

Ages Eligible for Study:	up to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pulmonary atresia
Pulmonary artery stenosis
Tetrology of Fallot with pulmonary arterial abnormalities
Truncus arteriosus
Anomalous venous return
Norwood repair for Hypoplastic Left Heart Syndrome
Aortoplasty in neonates (≤ 30 days old)

Exclusion Criteria:

Patients actively participating in the study of another investigational drug or device
Patients with known sensitivities to any processing reagents
Intracranial bleeding
Respiratory Distress Syndrome
Renal dysfunction

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411658

Locations


United States, Missouri
	Children's Mercy Hospitals and Clinics	Not yet recruiting
	Kansas City, Missouri, United States, 64108
	Contact: Gary Lofland, MD 816-234-3580
	Principal Investigator: Gary Lofland, MD

United States, Tennessee
	LeBonheur Children's Medical Center	Not yet recruiting
	Memphis, Tennessee, United States, 38103
	Contact: Jeff Myers, MD 901-572-5958
	Principal Investigator: Jeff Myers, MD

United States, Texas
	University of Texas Southwestern Medical Center	Not yet recruiting
	Dallas, Texas, United States, 75235
	Contact: Joseph Forbess, MD 214-456-2696
	Principal Investigator: Joseph Forbess, MD

Sponsors and Collaborators

LifeNet Health

Investigators


Study Chair:	Richard Hopkins, MD	Brown School of Medicine and Rhode Island Hospital

More Information

Study ID Numbers:	CR06-002
First Received:	December 13, 2006
Last Updated:	December 13, 2006
ClinicalTrials.gov Identifier:	NCT00411658
Health Authority:	United States: Food and Drug Administration

Keywords provided by LifeNet Health:

congenital cardiac abnormality

congenital cardiac defect

hypoplastic left heart syndrome

HLHP

pulmonary atresia

pulmonary arterial stenosis

truncus arteriosus

tetrology of Fallot

right ventricular outflow tract repair

RVOT repair

pediatric heart surgery

Study placed in the following topic categories:

Pulmonary Atresia

Hypoplastic Left Heart Syndrome

Constriction, Pathologic

Congenital Abnormalities

Hypoplastic left heart syndrome

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	LifeNet Health
Information provided by:	LifeNet Health
ClinicalTrials.gov Identifier:	NCT00411658