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

NCT ID: NCT04859036

Last Updated: 2021-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-01

Study Completion Date

2017-04-01

Brief Summary

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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

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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.

Conditions

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Ventricular Septal Defect Closure; Interventricular Septum Autonomic Nervous System Imbalance

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Transchateter VSD closure group

VSD cases treated with transcatheter closure method.

24 hours ambulatory Holter monitoring

Intervention Type DIAGNOSTIC_TEST

Control group

Healty children

24 hours ambulatory Holter monitoring

Intervention Type DIAGNOSTIC_TEST

Interventions

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24 hours ambulatory Holter monitoring

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

56 Months

Maximum Eligible Age

136 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kayseri City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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süleyman sunkak

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kazım Uzum, Prof.

Role: STUDY_CHAIR

TC Erciyes University

Locations

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Süleyman Sunkak

Kayseri, Kocasinan, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Narin N, Pamukcu O, Tuncay A, Baykan A, Sunkak S, Tasci O, Uzum K, Saltik L. Percutaneous Ventricular Septal Defect Closure in Patients Under 1 Year of Age. Pediatr Cardiol. 2018 Jun;39(5):1009-1015. doi: 10.1007/s00246-018-1852-5. Epub 2018 Mar 15.

Reference Type BACKGROUND
PMID: 29541816 (View on PubMed)

Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.

Reference Type BACKGROUND
PMID: 8598068 (View on PubMed)

Related Links

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http://pubmed.ncbi.nlm.nih.gov/8598068/

Standarts of heart rate variability parameters

Other Identifiers

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2014/39

Identifier Type: -

Identifier Source: org_study_id

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