Congenital Disorder Clinical Trial
Official title:
Pacemaker Therapy in Adults With Congenital Heart Defects
Review the feasibility, safety and outcomes in adults with congenital heart disease who undergo pacemaker implantation for bradycardia, tachycardia or heart failure indications
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.
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Observational Model: Cohort, Time Perspective: Retrospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03262168 -
Supported Exercise Programme for Adults With Congenital Heart Disease
|
N/A |