Follow Up on Freestyle Valves in Children

NCT00385112 | Completed

• 2 other identifiers: IRB0000012406-138
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the Medtronic Freestyle porcine valve is effective over a long period of time when it is used to replace the valve that normally allows blood to flow from the right lower pumping chamber of the heart to the lungs.

Conditions

Right Ventricle; Pulmonary Valve Stenosis; Pulmonary Valve Atresia

Keywords

Cardiology; Echocardiograms; Surgery; Valve Disease; Heart Valve Disease

Outcome Measures

Primary Outcomes (1)

• We hypothesize that this Medtronic Freestyle® porcine aortic root valve has good long term hemodynamic performance and longevity.

  Retrospective Chart Review

  Retrospective Chart Review

Interventions

Echocardiogram PROCEDURE

2D echocardiogram with Doppler flow

Eligibility Criteria

• Age: 8 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients that have received the Medtronic Freestyle® porcine aortic root for right ventricular outflow tract reconstruction that have not had a standard of care echocardiogram performed in the last 12 months.

You may qualify if:

• Patients that have received the Medtronic Freestyle® porcine aortic root for right ventricular outflow tract reconstruction that have not had a standard of care echocardiogram performed in the last 12 months.
• Patients that have received the Medtronic Freestyle® porcine aortic root for right ventricular outflow tract reconstruction whose most recent echocardiogram is not useful for evaluating the study points despite the fact that it may have been performed within the last 12 months.
• Informed consent obtained from the legal guardian or patient if \> 18 years of age.

You may not qualify if:

• Patients that have not received the Medtronic Freestyle® porcine aortic root for right ventricular outflow tract reconstruction.
• Patients that are eligible to participate based on the previous criteria for whom informed consent is not obtained from the patient or legal guardian.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Kanter KR, Fyfe DA, Mahle WT, Forbess JM, Kirshbom PM. Results with the freestyle porcine aortic root for right ventricular outflow tract reconstruction in children. Ann Thorac Surg. 2003 Dec;76(6):1889-94; discussion 1894-5. doi: 10.1016/s0003-4975(03)01304-3.

  PMID: 14667606 RESULT

MeSH Terms

Conditions

Pulmonary Valve Stenosis; Pulmonary Atresia; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Kirk R Kanter, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Pediatric Cardiac Surgery

Study Record Dates

• First Submitted: October 3, 2006
• First Posted: October 6, 2006
• Study Start: November 1, 2006
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

US (1)