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

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Brief Title

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

Official Title

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

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 Type

Observational


Primary Outcome

Heart rate variability parameters


Condition

Ventricular Septal Defect

Intervention

24 hours ambulatory Holter monitoring

Study Arms / Comparison Groups

 Transchateter VSD closure group
Description:  VSD cases treated with transcatheter closure method.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

37

Start Date

April 1, 2016

Completion Date

April 1, 2017

Primary Completion Date

April 1, 2017

Eligibility Criteria

        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
      

Gender

All

Ages

56 Months - 136 Months

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Kazım Uzum, Prof., , 

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations


NCT ID

NCT04859036

Organization ID

2014/39


Responsible Party

Principal Investigator

Study Sponsor

Kayseri City Hospital


Study Sponsor

Kazım Uzum, Prof., Study Chair, TC Erciyes University


Verification Date

April 2021