Pacemaker Therapy in Adults With Congenital Heart Defects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wendy M. Book, Emory University
ClinicalTrials.gov Identifier:
NCT00303511
First received: March 16, 2006
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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


Condition
Congenital Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pacemaker Therapy in Adults With Congenital Heart Defects

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Feasibility of Pacemaker Implant With Total Thoracoscopic Approach to Epicardial Pacing Lead [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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


Enrollment: 10
Study Start Date: January 1996
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults with congenital heart disease requiring epicardial pacemaker leads

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303511

Locations
United States, Georgia
Emory University SOM Adult Cardiac Clinic
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Wendy M Book, MD Emory University SOM
  More Information

No publications provided

Responsible Party: Wendy M. Book, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00303511     History of Changes
Other Study ID Numbers: 0103-2006
Study First Received: March 16, 2006
Results First Received: November 8, 2013
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
adult
pacemaker
bradycardia
tachycardia
heart failure

Additional relevant MeSH terms:
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 28, 2014