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Holter and ECG Changes After Transcatheter Closure Of VSD In Children

Holter and ECG Changes After Transcatheter Closure Of VSD In Children

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05890651
Enrollment
70
Registered
2023-06-06
Start date
2023-05-01
Completion date
2024-05-01
Last updated
2023-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

VSD Children

Brief summary

Ventricular septal defect (VSD) is the most common congenital heart now affecting children, which makes up 20 % of isolated congenital heart condition. Although VSD can develop in any area of the inter ventricular septum, the perimembranous VSD and muscular VSD which can occur anteriorly, posteriorly, inlet, or outlet, are the most frequent morphological forms. The supracristal varity is less prevelant. While many VSDs close spontaneously, if they do not, large defects can lead to detrimental complications such as pulmonary arterial hypertension (PAH), ventricular dysfunction, and an increased risk of arrhythmias. Hemodynamic impairment may arise according to the size and flow of the VSD. Hemodynamically unstable patients particularly benefit from a successful closure. After conventional open surgery to treat VSDs, complications from cardiopulmonary bypass, are infection, postpericardiotomy syndrome, chylothorax, and a full atrioventricular block are still conceivable (e.g., myocardial, and pulmonary injury, electrolyte imbalance, coagulopathy, and acute renal failure). Furthermore, when compared to nonsurgical treatments, prolonged postoperative stays in the ICU or hospital are required . The requirements for transcatheter intervention are determined by the size and type of VSD. Transcatheter closure of a moderate-sized VSD with congestive heart failure, failure to thrive, substantially enlarged left atrium and LV, or increased pulmonary artery pressures is frequently recommended (or both). A pulmonary-to-systemic flow ratio larger than 2:1 is also required. Large VSDs with RV and pulmonary artery systolic pressures close to the left ventricular and aortic systolic pressures should be closed. Since the first case was reported in 1988 and had satisfactory results, catheter- based therapies have demonstrated promising results in comparison to surgery Arrhythmia, especially CAVB, is one of the most important complications after transcatheter occluder closure of pmVSD. The incident rate of arrhythmias in the early postoperative period ranges from 15.3% to 24.1% Bundle branch block was a common complication with the highest incident rate both in the early and long-term follow-up. During follow-up, nearly half of the conduction block could return to normal, some of which could be worse or even deteriorate into CAVB. Some of the reported late-onset CAVB cases have been observed with different degrees of conduction block in the early postoperative period. Previous studies indicated that inlet occlusion increased the risk of LBBB whereas outlet occlusion decreased the associated risks. the underlying mechanism of arrhythmias after transcatheter pmVSD closure is still unclear. The risk factors may include age, weight, operation duration time, operation technique, anatomy location of the pmVSD, size of the occluder, morphological characteristics of the occluder, and so on, but the conclusions about risk factor were different in various researches .

Interventions

DIAGNOSTIC_TESTECG

Describe the electrocardiography (ECG) changes 24 hours,1,6,12 months after VSD transcatheter device closure in a pediatric population.

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* All children under the age of 18 years diagnosed with VSD , that will undergo transcatheter VSD closure during the period of the study .

Exclusion criteria

* Failure to obtain informed consent .

Design outcomes

Primary

MeasureTime frameDescription
ECG changes after VSD closure12 monthsthe study will focus to describe the arrhythemia that occur after VSD closure also detect heart rate varibility a day before VSD closure and aday after closure detect long run arrythemia after VSD closure within one year

Countries

Egypt

Contacts

Primary ContactRasha H Mahmoud, Resident
rashahassan@med.sohag.edu.eg01025664643
Backup ContactSafaa H Ali, Professor
01025664643

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026