Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT07191093
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of RV Dysfunction After BPV
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Predictors of Right Ventricle Dysfunction After Pulmonary Balloon Valvuloplasty
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
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:
This aim focuses on :
Assessing how common RV dysfunction is post-procedure Evaluating RV function changes over time (e.g., TAPSE, FAC, RV strain if available) Identifying risk factors or predictors (e.g., high residual gradient, severe PR, age at intervention)
Assessing how common RV dysfunction is post-procedure Evaluating RV function changes over time (e.g., TAPSE, FAC, RV strain if available) Identifying risk factors or predictors (e.g., high residual gradient, severe PR, age at intervention)
Detailed Description:
Pulmonary stenosis (PS) is a congenital or acquired narrowing of the right ventricular outflow tract (RVOT) at the level of the pulmonary valve, leading to obstruction of blood flow from the right ventricle (RV) to the pulmonary artery. It accounts for approximately 8-10% of all congenital heart diseases and occurs most commonly as an isolated valvular lesion. Valvular PS is characterized by thickened, fused, or dysplastic pulmonary valve leaflets, resulting in increased right ventricular pressure and compensatory hypertrophy. Over time, if untreated, this can progress to right ventricular dilation, dysfunction, and right-sided heart failure.
Pulmonary balloon valvuloplasty (PBV) is the treatment of choice for moderate to severe valvular pulmonary stenosis. It is a minimally invasive, catheter-based intervention that involves dilation of the stenotic pulmonary valve using an appropriately sized balloon. The goal is to relieve obstruction, reduce right ventricular pressure, and prevent long-term complications such as RV hypertrophy, dysfunction, and arrhythmias. The procedure has shown excellent immediate and long-term outcomes, particularly in patients with a pliable, doming pulmonary valve and no significant regurgitation or associated congenital lesions.
Despite the effectiveness and safety of PBV, complications can occur, and among them, right ventricular dysfunction is a critical concern. RV dysfunction post-valvuloplasty may result from several mechanisms, including longstanding pre-procedural pressure overload, myocardial fibrosis, sudden afterload reduction, procedural trauma, or development of significant pulmonary regurgitation. This dysfunction can be subtle or overt and may impact the long-term clinical outcome, exercise tolerance, and quality of life of patients.
Therefore, understanding the predictors of right ventricular dysfunction after pulmonary balloon valvuloplasty is essential. Identifying high-risk patients pre-intervention and monitoring RV function post-procedure using echocardiographic parameters such as TAPSE, fractional area change (FAC), RV strain, and tricuspid annular tissue Doppler velocity (S') can guide better management strategies.
Pulmonary balloon valvuloplasty (PBV) is the treatment of choice for moderate to severe valvular pulmonary stenosis. It is a minimally invasive, catheter-based intervention that involves dilation of the stenotic pulmonary valve using an appropriately sized balloon. The goal is to relieve obstruction, reduce right ventricular pressure, and prevent long-term complications such as RV hypertrophy, dysfunction, and arrhythmias. The procedure has shown excellent immediate and long-term outcomes, particularly in patients with a pliable, doming pulmonary valve and no significant regurgitation or associated congenital lesions.
Despite the effectiveness and safety of PBV, complications can occur, and among them, right ventricular dysfunction is a critical concern. RV dysfunction post-valvuloplasty may result from several mechanisms, including longstanding pre-procedural pressure overload, myocardial fibrosis, sudden afterload reduction, procedural trauma, or development of significant pulmonary regurgitation. This dysfunction can be subtle or overt and may impact the long-term clinical outcome, exercise tolerance, and quality of life of patients.
Therefore, understanding the predictors of right ventricular dysfunction after pulmonary balloon valvuloplasty is essential. Identifying high-risk patients pre-intervention and monitoring RV function post-procedure using echocardiographic parameters such as TAPSE, fractional area change (FAC), RV strain, and tricuspid annular tissue Doppler velocity (S') can guide better management strategies.
Study Oversight
Has Oversight DMC:
True
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?: