Pacemaker Therapy in Adults With Congenital Heart Defects
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|ClinicalTrials.gov Identifier: NCT00303511|
Recruitment Status : Completed
First Posted : March 17, 2006
Results First Posted : August 8, 2014
Last Update Posted : August 8, 2014
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Pacemaker Therapy in Adults With Congenital Heart Defects|
|Study Start Date :||January 1996|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||August 2006|
- Feasibility of Pacemaker Implant With Total Thoracoscopic Approach to Epicardial Pacing Lead [ Time Frame: 30 days ]The ability to place a pacemaker with capture (have the pacemaker work properly) through totally thoracoscopic approach to epicardial pacing lead without requiring conversion to open procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00303511
|United States, Georgia|
|Emory University SOM Adult Cardiac Clinic|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Wendy M Book, MD||Emory University SOM|