Ventricular Septal DefectNCT04859036
The Effect of Transcatheter Ventricular Septal Defect Closure on Heart Rate Variability Parameters
An observational study of Ventricular Septal Defect and Closure; Interventricular Septum, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 56 to 136 monthsHealthy volunteers can take part
- Conditions the study is for
- Ventricular Septal Defect, Closure; Interventricular Septum, Autonomic Nervous System Imbalance
- What is being tested?
- 24 hours ambulatory Holter monitoring
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2016to 1 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 56 to 136 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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)
Who cannot join
- Patients with arrhythmia after the procedure
- Young patients who may be inconsistent during Holter records
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Ventricular Septal Defect, Closure; Interventricular Septum, Autonomic Nervous System Imbalance
- Being tested
- 24 hours ambulatory Holter monitoring
- Keywords
- ventricular septal defect, heart rate variability, percutaneous VSD closure
- Medical subject headings
- Heart Septal Defects, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24 hours ambulatory Holter monitoringDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Transchateter VSD closure group | VSD cases treated with transcatheter closure method. Receives: Diagnostic Test: 24 hours ambulatory Holter monitoring | |
| Control group | Healty children Receives: Diagnostic Test: 24 hours ambulatory Holter monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability parameters
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Apr 2016
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventricular Septal DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, süleyman sunkak, Kayseri City Hospital
- Investigators
- Kazım Uzum, Prof., Study chair, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859036
- Sponsor's protocol ID
- 2014/39
- Status last verified
- Apr 2021
- First submitted
- 20 Apr 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29541816Heart 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.
PubMed 8598068
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcatheter Ventricular Septal Defect Closure on Heart Rate Variability Parameters
- ClinicalTrials.gov ID
- NCT04859036
- Acronym / sponsor ID
- 2014/39
- Conditions
- Ventricular Septal Defect, Closure; Interventricular Septum, Autonomic Nervous System Imbalance
- Keywords
- ventricular septal defect, heart rate variability, percutaneous VSD closure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transchateter VSD closure group | – | Diagnostic Test: 24 hours ambulatory Holter monitoringVSD cases treated with transcatheter closure method. |
| Control group | – | Diagnostic Test: 24 hours ambulatory Holter monitoringHealty children |
Who may qualify
- Ages
- 56 to 136 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Patients with arrhythmia after the procedure
- Young patients who may be inconsistent during Holter records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24 hours ambulatory Holter monitoring | Diagnostic test | Control group, Transchateter VSD closure group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Background: PubMed 29541816Narin 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.
- Background: PubMed 8598068Heart 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.
- VSD closure indicationsLink provided by the sponsor.
- Standarts of heart rate variability parametersLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazım Uzum, Prof. study chair
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Septal Defect and Closure; Interventricular Septum, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability parameters (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04859036, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.