The Effect of Transcatheter Ventricular Septal Defect Closure on Heart Rate Variability Parameters
NCT ID: NCT04859036
Last Updated: 2021-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
37 participants
OBSERVATIONAL
2016-04-01
2017-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transcatheter Versus Surgical Closure of Ventricular Septal Defect: A Comparative Study
NCT05306483
Effect of Mechanical Ventilation on Cardiac RF Ablation
NCT06986577
Holter and ECG Changes After Transcatheter Closure Of ASD In Children
NCT05540769
Ventricular Asynchrony in Cardiac Surgery Patients
NCT00654199
Cardiac Function After Transcatheter VSD Closure
NCT03127748
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Transchateter VSD closure group
VSD cases treated with transcatheter closure method.
24 hours ambulatory Holter monitoring
Control group
Healty children
24 hours ambulatory Holter monitoring
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
24 hours ambulatory Holter monitoring
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Young patients who may be inconsistent during Holter records
56 Months
136 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kayseri City Hospital
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
süleyman sunkak
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kazım Uzum, Prof.
Role: STUDY_CHAIR
TC Erciyes University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Süleyman Sunkak
Kayseri, Kocasinan, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
VSD closure indications
Standarts of heart rate variability parameters
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014/39
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.