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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

egypt assiut university contact

00201007478142

findinglemo@hotmail.com

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.

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 groups in NCT04163770
Study groupRoleWhat they receive
performance of pacemaker at time of implantationExperimentalNot described
Receives: Device: caliberation of pacemaker
performance of pacemaker 6 months after implantationExperimentalNot described
Receives: Device: caliberation of pacemaker

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Performance of pacemakers in children

    the performance will be assessed by Ventricular impedence in ohms

    Measured: 1 year

  2. 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.

  1. First posted15 Nov 2019
  2. Study start15 Jan 2020 (estimated)
  3. Primary completion15 Jan 2021 (estimated)
  4. Study completion15 Feb 2021 (estimated)

Resources

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)
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

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.

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