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

Completed

• Conditions: Closure; Interventricular Septum; Autonomic Nervous System Imbalance; Ventricular Septal Defect
• Interventions: Diagnostic Test: 24 hours ambulatory Holter monitoring

• Registration Number: NCT04859036
• Lead Sponsor: Kayseri City Hospital

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-04-01
• Primary Completion: 2017-04-01
• Study Completion: 2017-04-01
• Status Verified: 2021-04
• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-21
• Last Update Submitted: 2021-04-21
• Study First Posted: 2021-04-26
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	24 hours ambulatory Holter monitoring	Healty children
Transchateter VSD closure group	24 hours ambulatory Holter monitoring	VSD cases treated with transcatheter closure method.

Primary Outcome Measures

Name	Time	Method
Heart rate variability parameters	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

Trial Locations

Locations (1)

Süleyman Sunkak; 🇹🇷 Kayseri, Kocasinan, Turkey