Pacemaker Therapy in Adults With Congenital Heart Defects

NCT ID: NCT00303511

Last Updated: 2014-08-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1996-01-31
• Study Completion Date: 2006-08-31

Brief Summary

Review the feasibility, safety and outcomes in adults with congenital heart disease who undergo pacemaker implantation for bradycardia, tachycardia or heart failure indications

Detailed Description

Survival to adulthood is now common for children born with congenital heart defects (CHD). This improved survival is in large part due to advances in cardiac surgery over the past 4 decades. However, few cardiac surgical repairs are curative. Many 'repaired' children with congenital heart defects later develop problems as adults. Arrhythmias, need for additional surgery, and heart failure are the more common late sequelae of congenital heart disease (1). In addition, many adults with CHD will need a pacemaker for sick sinus syndrome (inability of the inherent pacemaker of the heart to function properly resulting in bradycardia sometimes alternating with tachycardia), tachyarrhythmias or heart block (2, 3). Certain group of patients, such as those with congenital corrected transposition of the great arteries (CCTGA), d-transposition s/p atrial switch procedures and those with single ventricle physiology are at particular risk of developing heart failure (4). Attached figures show the anatomy of these congenital heart defect. Cardiac resynchronization therapy improves exercise tolerance, symptoms and reduces mortality in adults with heart failure due to acquired left ventricular dysfunction.(5-8). In addition, automatic internal cardioverter - defibrillators (ICD) have now been shown to decrease mortality in patients with low ejection fraction due to ischemic or non-ischemic etiologies (9, 10).

Patients with CHD pose a challenge to traditional transvenous pacemaker lead placement due to either complex venous anatomy that precludes conventional percutaneous approaches for pacemaker implantation or occlusions of central venous form multiple prior procedures (11, 12). As evident in the study by Janousek et.al, 7 out of 8 patients enrolled in this study required a thoracotomy for lead placement (4). While thoracoscopic epicardial lead placement has been described for placement of pacemaker leads in adults without congenital heart defects (13, 14), it has not been described for adult patients with congenital heart disease.

Conditions

Congenital Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Congenital heart disease diagnosis
• Pacemaker implantation completed during the period of Jan. 1, 1996 to Dec. 1, 2005
• Age 18 to 80, inclusive

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Wendy M. Book

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wendy M Book, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University SOM

Locations

Emory University SOM Adult Cardiac Clinic

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

0103-2006

Identifier Type: -

Identifier Source: org_study_id