Disorder of Cardiac Pacemaker SystemNCT04163770
Evaluation Of Pacemakers in Children
A study testing caliberation of pacemaker in people with Disorder of Cardiac Pacemaker System, run by Assiut University.
Trial summary
Pacemakers were introduced into clinical practice several decades ago and currently are used in a growing number of patients. Since insertion of the first cardiac Pacemaker in 1958, vast changes have occurred in both the technology of the devices and their indications. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorder of Cardiac Pacemaker System
- What is being tested?
- caliberation of pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2020to 15 Feb 2021
- Phase
- Interventional
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pediatric age group 0 month -18 years Indicated for permanent cardiac pacing
Who cannot join
- Cardiomyopathy unrelated to rhythm disturbance.
- Significant systemic disease apart from the cardiac one
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation Of Performance & Complications of Pacemakers in Children
Pacemakers were introduced into clinical practice several decades ago and currently are used in a growing number of patients. Since insertion of the first cardiac Pacemaker in 1958, vast changes have occurred in both the technology of the devices and their indications. Devices have evolved from single-lead and fixed-rate systems to multi chamber rate-responsive systems with increasingly sophisticated software .
Pediatric Pacemaker implants comprise less than 1 % of all implants. The indications for pacing in newborns and infants are divided predominantly into three groups: congenital abnormalities of the conduction system, acquired heart blocks after cardiac surgery for correction of congenital defects, and sinus node diseases
Read the detailed description
Although advances in device and lead technology have expanded the ability to implant pacemakers and defibrillators in children and patients with congenital heart disease , a number of challenges exist that can complicate long-term pacing success in this unique population . These include a long duration of pacing need, a more active lifestyle in young patients, somatic growth, congenital cardiac abnormalities, and relatively small patient and vessel size. Traditional stylet driven leads have limited maneuverability, making lead placement in smaller patients and those with structural abnormalities more challenging.
Additionally, the larger lead diameter needed to accommodate the stylet has been correlated with increased risk of venous complications in children . Furthermore, many congenital heart disease patients have structural abnormalities and cardiac scarring that require pacing leads to be placed in non-standard locations, and selective site pacing can be difficult to achieve with stylet-driven leads .
Pacing therapy in children must take into account several unique pediatric issues: (1) small physique; (2) somatic growth; (3) presence of intracardiac shunts; and (4) a complex anatomical heart structure. It is important to understand these features when deciding whether pacing is indicated, as well as when selecting the time to implant and how to implant.
The 2008 Guidelines of the American College of Cardiology /American Heart Association /Heart Rhythm Society summarize indications for pacing treatment in children. Atrioventricular block including congenital atrioventricular block associated with cardiac surgery or a natural history of complex congenital heart disease such as corrected transposition of the great arteries are the most important indications for pacemaker implantation in children 8-13. In pediatric patients, atrioventricular block that does not recover within 7-10 days after cardiac surgery is associated with a risk of sudden cardiac death in the future, so pacemaker implantation is recommended.
Dual-chamber pacemakers are often selected for adult patients with atrioventricular block. Dual-chamber pacemakers pacing requires two endocardial leads. In infants, this presents a problem because the venous diameter is small and may cause venous obstruction. A single chamber ventricular pacemaker instead of a dual-chamber pacemaker is a good alternative choice in children with complete atrioventricular block and normal sinus node function, because it requires only a single lead and may reduce the possibility of venous occlusion. The high heart rate of infants is another issue. The mean heart rate of an infant is 100 bpm or faster, increasing to 180-200 bpm or above when crying. In an infant with atrioventricular block, the atrial rate becomes so rapid that it may exceed the maximum programmable upper tracking rate, which is limited by the post-ventricular atrial refractory period and atrioventricular delay. Under the condition where the atrial heart rate exceeds the maximum programmable upper tracking rate, symptomatic 2:1 atrioventricular block may occur. Therefore, in infants with a small body size and a rapid ventricular rate, single chamber ventricular pacing or single-chamber ventricular pacing with rate response should be selected.
- Conditions
- Disorder of Cardiac Pacemaker System
- Being tested
- caliberation of pacemaker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caliberation of pacemakerDevice
evaluation of ventricular impedence, ventricular sensing, ventricular capture threshold
caliberation of pacemakerDevice
evaluation of ventricular impedence, ventricular sensing, ventricular capture threshold
| Study group | Role | What they receive |
|---|---|---|
| performance of pacemaker at time of implantation | Experimental | Not described Receives: Device: caliberation of pacemaker |
| performance of pacemaker 6 months after implantation | Experimental | Not described Receives: Device: caliberation of pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of pacemakers in children
the performance will be assessed by Ventricular impedence in ohms
Measured: 1 year
Performance of pacemakers in children
the performance will be assessed by ventricular capture threshold in volt
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start15 Jan 2020 (estimated)
- Primary completion15 Jan 2021 (estimated)
- Study completion15 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disorder of Cardiac Pacemaker SystemStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khaled mohammed allam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163770
- Sponsor's protocol ID
- EPCP
- Status last verified
- Nov 2019
- First submitted
- 28 Oct 2019
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garnreiter J, Whitaker P, Pilcher T, Etheridge S, Saarel E. Lumenless pacing leads: performance and extraction in pediatrics and congenital heart disease. Pacing Clin Electrophysiol. 2015 Jan;38(1):42-7. doi: 10.1111/pace.12508. Epub 2014 Sep 16.
PubMed 25224253
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Performance & Complications of Pacemakers in Children
- ClinicalTrials.gov ID
- NCT04163770
- Acronym / sponsor ID
- EPCP
- Conditions
- Disorder of Cardiac Pacemaker System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (estimated)
- Primary completion
- 15 Jan 2021 (estimated)
- Study completion
- 15 Feb 2021 (estimated)
- First posted
- 15 Nov 2019 (actual)
- 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.
Pacemakers were introduced into clinical practice several decades ago and currently are used in a growing number of patients. Since insertion of the first cardiac Pacemaker in 1958, vast changes have occurred in both the technology of the devices and their indications. Devices have evolved from single-lead and fixed-rate systems to multi chamber rate-responsive systems with increasingly sophisticated software .
Pediatric Pacemaker implants comprise less than 1 % of all implants. The indications for pacing in newborns and infants are divided predominantly into three groups: congenital abnormalities of the conduction system, acquired heart blocks after cardiac surgery for correction of congenital defects, and sinus node diseases
Detailed description
Although advances in device and lead technology have expanded the ability to implant pacemakers and defibrillators in children and patients with congenital heart disease , a number of challenges exist that can complicate long-term pacing success in this unique population . These include a long duration of pacing need, a more active lifestyle in young patients, somatic growth, congenital cardiac abnormalities, and relatively small patient and vessel size. Traditional stylet driven leads have limited maneuverability, making lead placement in smaller patients and those with structural abnormalities more challenging.
Additionally, the larger lead diameter needed to accommodate the stylet has been correlated with increased risk of venous complications in children . Furthermore, many congenital heart disease patients have structural abnormalities and cardiac scarring that require pacing leads to be placed in non-standard locations, and selective site pacing can be difficult to achieve with stylet-driven leads .
Pacing therapy in children must take into account several unique pediatric issues: (1) small physique; (2) somatic growth; (3) presence of intracardiac shunts; and (4) a complex anatomical heart structure. It is important to understand these features when deciding whether pacing is indicated, as well as when selecting the time to implant and how to implant.
The 2008 Guidelines of the American College of Cardiology /American Heart Association /Heart Rhythm Society summarize indications for pacing treatment in children. Atrioventricular block including congenital atrioventricular block associated with cardiac surgery or a natural history of complex congenital heart disease such as corrected transposition of the great arteries are the most important indications for pacemaker implantation in children 8-13. In pediatric patients, atrioventricular block that does not recover within 7-10 days after cardiac surgery is associated with a risk of sudden cardiac death in the future, so pacemaker implantation is recommended.
Dual-chamber pacemakers are often selected for adult patients with atrioventricular block. Dual-chamber pacemakers pacing requires two endocardial leads. In infants, this presents a problem because the venous diameter is small and may cause venous obstruction. A single chamber ventricular pacemaker instead of a dual-chamber pacemaker is a good alternative choice in children with complete atrioventricular block and normal sinus node function, because it requires only a single lead and may reduce the possibility of venous occlusion. The high heart rate of infants is another issue. The mean heart rate of an infant is 100 bpm or faster, increasing to 180-200 bpm or above when crying. In an infant with atrioventricular block, the atrial rate becomes so rapid that it may exceed the maximum programmable upper tracking rate, which is limited by the post-ventricular atrial refractory period and atrioventricular delay. Under the condition where the atrial heart rate exceeds the maximum programmable upper tracking rate, symptomatic 2:1 atrioventricular block may occur. Therefore, in infants with a small body size and a rapid ventricular rate, single chamber ventricular pacing or single-chamber ventricular pacing with rate response should be selected.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| performance of pacemaker at time of implantation | Experimental | Device: caliberation of pacemaker |
| performance of pacemaker 6 months after implantation | Experimental | Device: caliberation of pacemaker |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric age group 0 month -18 years Indicated for permanent cardiac pacing
Key exclusion criteria (2 listed)
- Cardiomyopathy unrelated to rhythm disturbance.
- Significant systemic disease apart from the cardiac one
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| caliberation of pacemakerevaluation of ventricular impedence, ventricular sensing, ventricular capture threshold | Device | performance of pacemaker at time of implantation |
| caliberation of pacemakerevaluation of ventricular impedence, ventricular sensing, ventricular capture threshold | Device | performance of pacemaker 6 months after implantation |
Primary outcome
Performance of pacemakers in children
Time frame: 1 year
the performance will be assessed by Ventricular impedence in ohms
Performance of pacemakers in children
Time frame: 1 year
the performance will be assessed by ventricular capture threshold in volt
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Background: PubMed 25224253Garnreiter J, Whitaker P, Pilcher T, Etheridge S, Saarel E. Lumenless pacing leads: performance and extraction in pediatrics and congenital heart disease. Pacing Clin Electrophysiol. 2015 Jan;38(1):42-7. doi: 10.1111/pace.12508. Epub 2014 Sep 16.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing caliberation of pacemaker in people with Disorder of Cardiac Pacemaker System, run by Assiut University.
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 2 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: status not confirmed, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact egypt assiut university (00201007478142, findinglemo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of pacemakers in children (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04163770, which also lists 1 linked publication.
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 15 Nov 2019.