NCT04859036

Brief Summary

In this study; we evaluated the heart rate variability parameters of pediatric patients whose VSDs were closed with the transcatheter method before and after, and compared with the control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

April 20, 2021

Last Update Submit

April 21, 2021

Conditions

Ventricular Septal DefectClosure; Interventricular SeptumAutonomic Nervous System Imbalance

Keywords

ventricular septal defectheart rate variabilitypercutaneous VSD closure

Outcome Measures

Primary Outcomes (1)

  • Heart rate variability parameters

    Time Domain analysis: After ectopic beats and artifacts were excluded, the following indices were calculated for time domian analysis in the whole Holter recording. * SDNN: Standard deviation of all filtered RR intervals * SDANN: Standard deviation of 5-minute averages of RR intervals * SDNNindex: Mean of the standard deviation of all RR intervals for all the 5-minute segments * rMSSD: Square root of the mean of the sum of square differences between adjacent filtered RR interval * PNN50: Percentage of the difference between adjacent RR intervals greater than 50 milliseconds Frequency domain analysis: We determined spectral power over three frequency. * Very low frequency (VLF) index (0.003-0.04 Hz) * Low frequency (LF) index (0.04 - 0.15 Hz) * High frequency (HF) index (0.15 - 0.40 Hz) * Total power: Variance of all NN intervals approximately \<0.4 Hz

    24 hours

Study Arms (2)

Transchateter VSD closure group

VSD cases treated with transcatheter closure method.

Diagnostic Test: 24 hours ambulatory Holter monitoring

Control group

Healty children

Diagnostic Test: 24 hours ambulatory Holter monitoring

Interventions

24 hours ambulatory Holter monitoringDIAGNOSTIC_TEST
Control groupTranschateter VSD closure group

Eligibility Criteria

Age56 Months - 136 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The patient group consists of pediatric patients who underwent transcatheter VSD closure in our institute. The control group consists of children who admitted to our institute with the complaint of palpitations and had a normal Holter record.

You may qualify if:

  • VSD diameter \<6mm
  • Significant left-to-right shunt
  • Left atrial and ventricular enlargement detected by echocardiography or calculation of Qp/Qs ratio above 1.5 in the catheterization laboratory (Qp/Qs\>1.5)

You may not qualify if:

  • Patients with arrhythmia after the procedure
  • Young patients who may be inconsistent during Holter records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Süleyman Sunkak

Kayseri, Kocasinan, 38080, Turkey (Türkiye)

Location

Related Publications (2)

  • Narin N, Pamukcu O, Tuncay A, Baykan A, Sunkak S, Tasci O, Uzum K, Saltik L. Percutaneous Ventricular Septal Defect Closure in Patients Under 1 Year of Age. Pediatr Cardiol. 2018 Jun;39(5):1009-1015. doi: 10.1007/s00246-018-1852-5. Epub 2018 Mar 15.

    PMID: 29541816BACKGROUND

  • Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.

    PMID: 8598068BACKGROUND

Related Links

MeSH Terms

Conditions

Heart Septal Defects, Ventricular

Condition Hierarchy (Ancestors)

Heart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Kazım Uzum, Prof.

    TC Erciyes University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 26, 2021

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

April 26, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)