Congenital DisorderNCT00303511
Pacemaker Therapy in Adults With Congenital Heart Defects
An observational study of Congenital Disorder, run by Emory University at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Congenital Disorder
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1996to Aug 2006
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with congenital heart disease requiring epicardial pacemaker leads
Who may be able to join
- Congenital heart disease diagnosis
- Pacemaker implantation completed during the period of Jan. 1, 1996 to Dec. 1, 2005
- Age 18 to 80, inclusive
Who cannot join
- Those who do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University SOM Adult Cardiac Clinic
Atlanta, Georgia, 30322
About this study
Review the feasibility, safety and outcomes in adults with congenital heart disease who undergo pacemaker implantation for bradycardia, tachycardia or heart failure indications
Read the 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.
- Conditions
- Congenital Disorder
- Keywords
- adult, pacemaker, bradycardia, tachycardia, heart failure
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Bradycardia, Tachycardia, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2006 (estimated)
- Study startJan 1996
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congenital DisorderStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy M. Book, Emory University
- Investigators
- Wendy M Book, MD, Principal investigator, Emory University SOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00303511
- Sponsor's protocol ID
- 0103-2006
- Status last verified
- Jul 2014
- First submitted
- 16 Mar 2006
- Last updated
- 8 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pacemaker Therapy in Adults With Congenital Heart Defects
- ClinicalTrials.gov ID
- NCT00303511
- Acronym / sponsor ID
- 0103-2006
- Conditions
- Congenital Disorder
- Keywords
- adult, pacemaker, bradycardia, tachycardia, heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jan 1996
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 17 Mar 2006 (estimated)
- Results
- Posted 8 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with congenital heart disease requiring epicardial pacemaker leads
Key inclusion criteria (3 listed)
- Congenital heart disease diagnosis
- Pacemaker implantation completed during the period of Jan. 1, 1996 to Dec. 1, 2005
- Age 18 to 80, inclusive
Key exclusion criteria (1 listed)
- Those who do not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy M Book, MD principal investigator
Emory University SOM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Disorder, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Pacemaker Implant With Total Thoracoscopic Approach to Epicardial Pacing Lead (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2014.