Clinical trial NCT00303511: Pacemaker Therapy in Adults With Congenital Heart Defects
Official title: Pacemaker Therapy in Adults With Congenital Heart Defects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Disorder
Keywords: adult
pacemaker
bradycardia
tachycardia
heart failure
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2006-03-17
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with congenital heart disease requiring epicardial pacemaker leads

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.

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

Exclusion Criteria:

* Those who do not meet inclusion criteria

Primary outcomes:
measure: Feasibility of Pacemaker Implant With Total Thoracoscopic Approach to Epicardial Pacing Lead
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University SOM Adult Cardiac Clinic
state: Georgia
Study officials:
affiliation: Emory University SOM
name: Wendy M Book, MD
role: PRINCIPAL_INVESTIGATOR
References: