Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05890651
Status:
RECRUITING
Last Update Posted:
2023-06-06
First Post:
2023-05-24
Brief Title:
Holter and ECG Changes After Transcatheter Closure Of VSD In Children
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Holter and ECG Changes After Transcatheter Closure Of VSD In Children
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 21 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 153 to 241 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
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 eg 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 21 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 153 to 241 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None