Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00303511
Status:
COMPLETED
Last Update Posted:
2014-08-08
First Post:
2006-03-16
Brief Title:
Pacemaker Therapy in Adults With Congenital Heart Defects
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Pacemaker Therapy in Adults With Congenital Heart Defects
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 sp 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 dysfunction5-8 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 etal 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
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 etal 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None