Reproduction and Survival After Cardiac Defect Repair

February 17, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
To create a registry of all Oregon children undergoing surgical repair of congenital heart disease since 1958 in order to determine mortality, morbidity, and disability after surgery and to assess the safety of pregnancy in women with corrected congenital heart disease and the risk of prematurity and occurrence of congenital heart defects in offspring.

Study Overview

Status

Completed

Conditions

Detailed Description

BACKGROUND:

Since 1960, surgical advances have led to correction of congenital heart defects in children who otherwise may not have achieved maturity. Consequently, it became increasingly important to understand the long-term morbidity, mortality and functional status of these patients. Because of the tremendous outlay of time, money and personnel devoted to prolonging the lives of children with congenital heart defects, it was vital to examine the accomplishment of long-term goals: achievement of a normal lifespan as a functioning, effective member of society.

DESIGN NARRATIVE:

Preoperative, operative, and postoperative data for each patient were entered into the registry data base at chart review. Follow-up for each patient was gathered by mail questionnaire, telephone survey, and the National Death Index. Questionnaires assessed morbidity, functional status, and reproduction. Pregnancy and major events were confirmed from physicians' records. Follow-up for tetralogy of Fallot, ventricular septal defect, and atrial septal defect was conducted in years 1, 3, and 5, and for transposition of the great arteries, aortic stenosis, pulmonic stenosis, patent ductus arteriosus, and coarctation of the aorta in years 2 and 4. Chart review was completed in year 2 and cases were then identified prospectively. Actuarial analysis and Cox proportional hazards models determined mortality, major morbidity, and their risk factors. Reproductive data were analyzed per years of fertility for the cohort, and compared to Oregon population statistics. During 1988-1989, chart review and data abstraction were completed for children having surgical corrections from 1958-1987 for the eight defects under study. Also, during 1988-1989, children undergoing cardiac surgery for the eight defects were added to the registry.

The study was renewed in 1993 to sustain and expand the registry of all Oregon children 18 years of age or younger undergoing surgical repair from 1958 to the present of 14 major congenital heart defects: tetralogy of Fallot (TOF), ventricular septal defect (VSD), atrial septal defect (ASD), coarctation of the aorta, pulmonic stenosis (PS), aortic stenosis (AS), transposition of the great arteries, patent ductus arteriosus (PDA), tricuspid atresia (TA), total anomalous pulmonary venous return (TAPVR), pulmonary atresia with intact ventricular septum (PA), PA with VSD, partial atrioventricular canal (AVC), and complete AVC. The first eight defects were included in the registry: TOF (n =438). VSD (n =402), ASD (n =496), COA (n =479), AS (n = 175), PS (n = 200), TGA (n = 169), and PDA (n = 533). All cases of surgical treatment of TA, TAPVR, PA, PA with VSD, and partial and complete AVC from 1958 to the present were added to the registry. Preoperative, operative, and postoperative data for each patient were entered into the database from chart review. Each hospital was visited twice yearly to ascertain new cases. Individuals were followed every two years for intercurrent events by mailed questionnaire or phone interview. Questionnaires and interviews assessed major morbidity, functional status, and reproduction. Pregnancy, major events, and recurrent CHD were confirmed by medical records. Actuarial analysis and the Cox proportional hazards model determined mortality, morbidity, and their risk factors, and compared observed survival with expected population survival. Reproductive data were analyzed per years of fertility for cohort, and compared to Oregon population statistics.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1986

Study Completion (Actual)

December 1, 1998

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimate)

May 26, 2000

Study Record Updates

Last Update Posted (Estimate)

February 18, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

October 1, 2001

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1068
  • R01HL039052 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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