Clinical trial NCT04859036: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Septal Defect
Closure; Interventricular Septum
Autonomic Nervous System Imbalance
Keywords: ventricular septal defect
heart rate variability
percutaneous VSD closure
Lead sponsor: Kayseri City Hospital
Sponsor class: OTHER_GOV
First posted: 2021-04-26
Enrollment: 37
Sex: ALL
Minimum age (years): 56
Maximum age (years): 136
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Heart rate variability parameters
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Süleyman Sunkak
state: Kocasinan
Study officials:
affiliation: TC Erciyes University
name: Kazım Uzum, Prof.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.