Congenital DisordersNCT00267423
Biventricular Pacing in the Pediatric Population
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
Hypothesis 1 (H1): Epicardial biventricular pacing is a safe and feasible method of pacing in young patients. Over the last two years, physicians at Children's Healthcare of Atlanta have been implanting epicardial BiV pacing systems in children determined to have ventricular dyssynchrony caused by numerous cardiac… Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Congenital Disorders
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to not given
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- any pediatric patient who received an epicardial BiV pacing system at Children's Healthcare of Atlanta between January 2002 and May 2004.
Who cannot join
- those patients who do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: A Single Center, Retrospective Study of the Safety and Feasibility of Epicardial Biventricular Pacing in the Pediatric Population
Hypothesis 1 (H1): Epicardial biventricular pacing is a safe and feasible method of pacing in young patients.
Over the last two years, physicians at Children's Healthcare of Atlanta have been implanting epicardial BiV pacing systems in children determined to have ventricular dyssynchrony caused by numerous cardiac diagnoses. The decision to use these pacing systems was based on the knowledge gained by adult studies. Since the use of these pacing systems in the pediatric population has not been formally studied, we propose a study to retrospectively review the safety and feasibility of epicardial BiV pacing in pediatric patients. This study will involve the review of the medical records of children who received epicardial BiV systems at Children's Healthcare of Atlanta between January 2002 and May 2004.
Read the detailed description
Synchronous activation of the right and left ventricles requires a normally functioning sinoatrial (SA) node, atrioventricular (AV) node and ventricular conduction system. When AV conduction has been interrupted by congenital heart block or acquired damage to the AV node, impulses arising from the SA node do not reach the ventricular myocardium. Standard therapy involves the placement of a permanent pacing system. In young children, such a system consists of either placing a single epicardial pacing lead on the right ventricular (RV) surface or separate epicardial pacing leads placed on the right atrium (RA) and RV. The former is commonly referred to as single chamber pacing and the latter as dual chamber pacing [AV sequential, single-site (SS) ventricular pacing]. The decision regarding single versus dual chamber lead placement is heavily influenced by operator convenience in the setting of a limited sternotomy. The main functions of the pacing system are sensing spontaneous activity and delivering pacing stimuli when appropriate. The two major advantages of dual chamber pacing are maintenance of physiologic heart rates and restoration of AV synchrony. The disadvantage of this system, however, is that the intrinsic synchronous depolarization of the ventricles is interrupted by initial paced ventricular activation in the RV rather than via the specialized His-Purkinje system; thus desynchronizing ventricular electrical activation. In addition, recent studies have demonstrated that despite early institution of cardiac pacing, some infants and children with AV block (AVB) develop late-onset left ventricular (LV) dilated cardiomyopathy over a follow-up period of 10 years.(1) The underlying mechanisms for this cardiomyopathy are not clear. A novel method of pacing (biventricular pacing, BiV) has been used in adult patients with left bundle branch block (LBBB, which results in dysynchronous ventricular activation) and congestive heart failure (CHF). Biventricular pacing in adults involves transvenous endocardial pacing leads placed in the RA, RV apex and LV via the coronary sinus. This results in "resynchronization" of ventricular activation, presumably by restoring a "normal" ventricular activation sequence, and has been associated with decreased CHF symptoms and improved ventricular function.
Children with acquired or congenital AVB, on the other hand, typically have a narrow QRS; owing to a midline ventricular escape rhythm and synchronous ventricular activation. The typical modes of pacing (VVI or DDD, single-site ventricular) in these children result in interventricular dyssynchrony, as described above. Recent studies in adult populations (DAVID, AAIR vs. DDDR in SSS, and MOde Selection trials)(2-4) demonstrated the detrimental effects of standard single-site ventricular pacing. Unfortunately, children with acquired and/or congenital AVB do not have the option of pacing or no pacing, and are destined to potentially decades of being 100% ventricular paced. This further emphasizes the importance of optimizing pacing strategies in this young, vulnerable population.
Specific Aim 1 (SA1): To evaluate the safety and feasibility of biventricular epicardial pacing in children.
- Conditions
- Congenital Disorders
- Keywords
- pediatric, cardiac, electrophysiology, epicardial biventricular pacing
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2005 (estimated)
- Study startJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital DisordersStudies of the same condition, open and under way.
- 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
- Defined population
- Time perspective
- Retrospective
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Investigators
- Patrick A Frias, MD, Principal investigator, Sibley Heart Center Cardiology at Children't Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267423
- Sponsor's protocol ID
- 04-040
- Status last verified
- May 2007
- First submitted
- 19 Dec 2005
- Last updated
- 4 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Retrospective Study of the Safety and Feasibility of Epicardial Biventricular Pacing in the Pediatric Population
- ClinicalTrials.gov ID
- NCT00267423
- Acronym / sponsor ID
- 04-040
- Conditions
- Congenital Disorders
- Keywords
- pediatric, cardiac, electrophysiology, epicardial biventricular pacing
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 12 participants
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Jan 2002
- First posted
- 21 Dec 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.
Hypothesis 1 (H1): Epicardial biventricular pacing is a safe and feasible method of pacing in young patients.
Over the last two years, physicians at Children's Healthcare of Atlanta have been implanting epicardial BiV pacing systems in children determined to have ventricular dyssynchrony caused by numerous cardiac diagnoses. The decision to use these pacing systems was based on the knowledge gained by adult studies. Since the use of these pacing systems in the pediatric population has not been formally studied, we propose a study to retrospectively review the safety and feasibility of epicardial BiV pacing in pediatric patients. This study will involve the review of the medical records of children who received epicardial BiV systems at Children's Healthcare of Atlanta between January 2002 and May 2004.
Detailed description
Synchronous activation of the right and left ventricles requires a normally functioning sinoatrial (SA) node, atrioventricular (AV) node and ventricular conduction system. When AV conduction has been interrupted by congenital heart block or acquired damage to the AV node, impulses arising from the SA node do not reach the ventricular myocardium. Standard therapy involves the placement of a permanent pacing system. In young children, such a system consists of either placing a single epicardial pacing lead on the right ventricular (RV) surface or separate epicardial pacing leads placed on the right atrium (RA) and RV. The former is commonly referred to as single chamber pacing and the latter as dual chamber pacing [AV sequential, single-site (SS) ventricular pacing]. The decision regarding single versus dual chamber lead placement is heavily influenced by operator convenience in the setting of a limited sternotomy. The main functions of the pacing system are sensing spontaneous activity and delivering pacing stimuli when appropriate. The two major advantages of dual chamber pacing are maintenance of physiologic heart rates and restoration of AV synchrony. The disadvantage of this system, however, is that the intrinsic synchronous depolarization of the ventricles is interrupted by initial paced ventricular activation in the RV rather than via the specialized His-Purkinje system; thus desynchronizing ventricular electrical activation. In addition, recent studies have demonstrated that despite early institution of cardiac pacing, some infants and children with AV block (AVB) develop late-onset left ventricular (LV) dilated cardiomyopathy over a follow-up period of 10 years.(1) The underlying mechanisms for this cardiomyopathy are not clear. A novel method of pacing (biventricular pacing, BiV) has been used in adult patients with left bundle branch block (LBBB, which results in dysynchronous ventricular activation) and congestive heart failure (CHF). Biventricular pacing in adults involves transvenous endocardial pacing leads placed in the RA, RV apex and LV via the coronary sinus. This results in "resynchronization" of ventricular activation, presumably by restoring a "normal" ventricular activation sequence, and has been associated with decreased CHF symptoms and improved ventricular function.
Children with acquired or congenital AVB, on the other hand, typically have a narrow QRS; owing to a midline ventricular escape rhythm and synchronous ventricular activation. The typical modes of pacing (VVI or DDD, single-site ventricular) in these children result in interventricular dyssynchrony, as described above. Recent studies in adult populations (DAVID, AAIR vs. DDDR in SSS, and MOde Selection trials)(2-4) demonstrated the detrimental effects of standard single-site ventricular pacing. Unfortunately, children with acquired and/or congenital AVB do not have the option of pacing or no pacing, and are destined to potentially decades of being 100% ventricular paced. This further emphasizes the importance of optimizing pacing strategies in this young, vulnerable population.
Specific Aim 1 (SA1): To evaluate the safety and feasibility of biventricular epicardial pacing in children.
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- any pediatric patient who received an epicardial BiV pacing system at Children's Healthcare of Atlanta between January 2002 and May 2004.
Key exclusion criteria (1 listed)
- those patients 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
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 4 May 2007.
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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.
Patrick A Frias, MD principal investigator
Sibley Heart Center Cardiology at Children't Healthcare of Atlanta
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 Disorders, run by Children's Healthcare of Atlanta 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 4 May 2007. 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 4 May 2007.