Heart Block After SurgeryNCT00208624
Rhythm Disturbances After Ventricular Septal Defects
An observational study of Heart Block After Surgery, run by Emory University at 1 site in United States.
Trial summary
We would like to conduct a retrospective chart review examining the incidence of surgical heart block in children treated in the Cardiac Service Line at Children's Healthcare of Atlanta. We would like to look at the last 30 surgical heart block cases seen at Children's Healthcare of Atlanta. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Block After Surgery
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to May 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with heart block after surgery -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
About this study
We would like to conduct a retrospective chart review examining the incidence of surgical heart block in children treated in the Cardiac Service Line at Children's Healthcare of Atlanta. We would like to look at the last 30 surgical heart block cases seen at Children's Healthcare of Atlanta. We will collect the following information on each patient:
Patient Date of Birth Date of the surgical procedure
Read more
Weight of the patient at the time of surgery Concomitant Diagnoses Need for permanent pacemaker Outcome of pacing (i.e. pacing successful)
We hope to look at each data element in order to determine potential risks factors for surgical heart block. By identifying the risk factors, the investigator hopes to establish a training program regarding surgical avoidance of certain areas of the heart (if possible) and education regarding pacemaker follow-up.
Each patient will be given a unique study number. The patient's name, social security number, medical record number or initials will not be used in our research database.
- Conditions
- Heart Block After Surgery
- Keywords
- arrhythmia, pediatrics, cardiac
- Medical subject headings
- Arrhythmias, Cardiac
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Block After SurgeryStudies 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
- Time perspective
- Retrospective
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin O. Maher, MD, Emory University
- Investigators
- Kevin Maher, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208624
- Sponsor's protocol ID
- 04-118
- Status last verified
- May 2014
- First submitted
- 13 Sep 2005
- Last updated
- 5 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhythm Disturbances After Ventricular Septal Defects
- ClinicalTrials.gov ID
- NCT00208624
- Acronym / sponsor ID
- 04-118
- Conditions
- Heart Block After Surgery
- Keywords
- arrhythmia, pediatrics, cardiac
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 30 participants
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Dec 2004
- Study completion
- May 2005
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We would like to conduct a retrospective chart review examining the incidence of surgical heart block in children treated in the Cardiac Service Line at Children's Healthcare of Atlanta. We would like to look at the last 30 surgical heart block cases seen at Children's Healthcare of Atlanta. We will collect the following information on each patient:
Patient Date of Birth Date of the surgical procedure
Weight of the patient at the time of surgery Concomitant Diagnoses Need for permanent pacemaker Outcome of pacing (i.e. pacing successful)
We hope to look at each data element in order to determine potential risks factors for surgical heart block. By identifying the risk factors, the investigator hopes to establish a training program regarding surgical avoidance of certain areas of the heart (if possible) and education regarding pacemaker follow-up.
Each patient will be given a unique study number. The patient's name, social security number, medical record number or initials will not be used in our research database.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with heart block after surgery -
Key exclusion criteria (1 listed)
- -
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
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
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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.
Kevin Maher, MD principal investigator
Emory University
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 Heart Block After Surgery, 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 1 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: stopped early, as of the sponsor's last update on 5 May 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?
The study was stopped early. Results are not available in the source record.
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.
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 5 May 2014.