Evaluation Of Pacemakers in Children

Disorder of Cardiac Pacemaker System Clinical Trial

Official title:

Evaluation Of Performance & Complications of Pacemakers in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04163770
• Other study ID #: EPCP
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: November 2019
• Source: Assiut University
• Contact: egypt assiut university
• Phone: 00201007478142
• Email: findinglemo[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Pediatric age group 0 month -18 years Indicated for permanent cardiac pacing

Exclusion Criteria:

• Cardiomyopathy unrelated to rhythm disturbance.

• Significant systemic disease apart from the cardiac one

Related Conditions & MeSH terms

• Disorder of Cardiac Pacemaker System

Intervention

Device:
• caliberation of pacemaker
evaluation of ventricular impedence, ventricular sensing, ventricular capture threshold
• caliberation of pacemaker
evaluation of ventricular impedence, ventricular sensing, ventricular capture threshold

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of pacemakers in children	the performance will be assessed by Ventricular impedence in ohms	1 year
Primary	Performance of pacemakers in children	the performance will be assessed by ventricular capture threshold in volt	1 year