Evaluation Of Pacemakers in Children
Evaluation Of Performance & Complications of Pacemakers in Children
1 other identifier
interventional
40
0 countries
N/A
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2019
CompletedFirst Posted
Study publicly available on registry
November 15, 2019
CompletedStudy Start
First participant enrolled
January 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2021
CompletedNovember 15, 2019
November 1, 2019
1 year
October 28, 2019
November 14, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Performance of pacemakers in children
the performance will be assessed by Ventricular impedence in ohms
1 year
Performance of pacemakers in children
the performance will be assessed by ventricular capture threshold in volt
1 year
Study Arms (2)
performance of pacemaker at time of implantation
EXPERIMENTALperformance of pacemaker 6 months after implantation
EXPERIMENTALInterventions
evaluation of ventricular impedence, ventricular sensing, ventricular capture threshold
Eligibility Criteria
You may qualify if:
- Pediatric age group 0 month -18 years Indicated for permanent cardiac pacing
You may not qualify if:
- Cardiomyopathy unrelated to rhythm disturbance.
- Significant systemic disease apart from the cardiac one
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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.
PMID: 25224253BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant lecturer of pediatric
Study Record Dates
First Submitted
October 28, 2019
First Posted
November 15, 2019
Study Start
January 15, 2020
Primary Completion
January 15, 2021
Study Completion
February 15, 2021
Last Updated
November 15, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share