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

K

Kayseri City Hospital

Status

Completed

Conditions

Autonomic Nervous System Imbalance
Closure; Interventricular Septum
Ventricular Septal Defect

Treatments

Diagnostic Test: 24 hours ambulatory Holter monitoring

Study type

Observational

Funder types

Other

Identifiers

NCT04859036
2014/39

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

All

Ages

56 to 136 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

37 participants in 2 patient groups

Transchateter VSD closure group
Description:
VSD cases treated with transcatheter closure method.
Treatment:
Diagnostic Test: 24 hours ambulatory Holter monitoring
Control group
Description:
Healty children
Treatment:
Diagnostic Test: 24 hours ambulatory Holter monitoring

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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