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

April 21, 2021 updated by: süleyman sunkak, Kayseri City Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kocasinan
      • Kayseri, Kocasinan, Turkey, 38080
        • Süleyman Sunkak

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kayseri City Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

April 21, 2021

First Posted (Actual)

April 26, 2021

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 21, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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