The Effect of Transcatheter Ventricular Septal Defect Closure on Heart Rate Variability Parameters

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.

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Key information

Conditions

Ventricular Septal Defect Autonomic Nervous System Imbalance Cardiovascular Abnormalities Cardiovascular Diseases Closure; Interventricular Septum Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Ventricular

Age range

56 month–136 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Süleyman Sunkak

Kayseri, Kocasinan, 38080, Turkey (Türkiye)

About this study

Heart rate variability (HRV) is a sign of cardiac autonomic nervous system. Evaluation of HRV in pediatric ventricular septal defect (VSD) cases before and after transcatheter closure will enlighten us in terms of cardiac autonomic control.

Methods: 19 VSD cases treated with transcatheter closure method and 18 healthy children were enrolled in the study. 24 hours Holter rhythm monitorization was applied to all patients before closure of VSD and to the control group. In the patient group, Holter rhythm monitorization was repeated in the third months. HRV parameters were obtained from Cardio Scan Premier 12® program. Frequency domain (Total power, VLF, LF, HF, LF/HF ratio) and time domain analysis (SDNN, SDANN, SDNNi, pNN50, rMSSD) were applied.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

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

Treatment and study plan

24 hours ambulatory Holter monitoring

Diagnostic Test

Primary outcomes

Heart rate variability parameters

Time frame: 24 hours
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

Sponsors and collaborators

Lead sponsor

Kayseri City Hospital

Other Gov

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Apr 26, 2021
Registry last updated: Apr 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed