Pacemaker Therapy in Adults With Congenital Heart Defects

Congenital Disorder Clinical Trial

Official title:

Pacemaker Therapy in Adults With Congenital Heart Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00303511
• Other study ID #: 0103-2006
• Status: Completed
• Phase: N/A
• First received: March 16, 2006
• Last updated: July 16, 2014
• Start date: January 1996
• Est. completion date: August 2006

Study information

• Verified date: July 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Congenital Disorder
• Heart Defects, Congenital

Locations

Country	Name	City	State
United States	Emory University SOM Adult Cardiac Clinic	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Pacemaker Implant With Total Thoracoscopic Approach to Epicardial Pacing Lead	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	30 days	No