NCT00303511

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 1996

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1996

Completed
10.2 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
8 years until next milestone

Results Posted

Study results publicly available

August 8, 2014

Completed
Last Updated

August 8, 2014

Status Verified

July 1, 2014

Enrollment Period

10.6 years

First QC Date

March 16, 2006

Results QC Date

November 8, 2013

Last Update Submit

July 16, 2014

Conditions

Congenital Disorder

Keywords

adultpacemakerbradycardiatachycardiaheart failure

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with congenital heart disease requiring epicardial pacemaker leads

You may qualify if:

  • Congenital heart disease diagnosis
  • Pacemaker implantation completed during the period of Jan. 1, 1996 to Dec. 1, 2005
  • Age 18 to 80, inclusive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University SOM Adult Cardiac Clinic

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesBradycardiaTachycardiaHeart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCardiac Conduction System Disease

Results Point of Contact

Title
Dr. Wendy Book
Organization
Emory University
wbook@emory.edu
404-778-5545

Study Officials

  • Wendy M Book, MD

    Emory University SOM

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 16, 2006

First Posted

March 17, 2006

Study Start

January 1, 1996

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

August 8, 2014

Results First Posted

August 8, 2014

Record last verified: 2014-07

Locations

US(1)