Predictors of RV Dysfunction After BPV

NCT07191093 | Active Not Recruiting DMC

• 1 other identifier: RV Dysfunction post BPV
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Conditions

RV Dysfunction; Pulmonary Valvuloplasty

Outcome Measures

Primary Outcomes (4)

• Change in peak transvalvular gradient after PBV

  Baseline, 72 hours post-procedure, and 6 months follow-up.

• Change in mean transvalvular gradient after pulmonary balloon valvuloplasty

  Baseline, 72 hours post-procedure, and 6 months follow-up.

• Change in estimated pulmonary artery systolic pressure PASP after PBV

  Baseline, 72 hours post-procedure, and 6 months follow-up.

• Change in TAPSE after PBV

  Baseline, 72 hours post-procedure, and 12 months follow-up

Secondary Outcomes (1)

• Procedural outcomes and complications

  one year

Interventions

pulmonary valvuloplasty PROCEDURE

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include patients with isolated valvular pulmonary stenosis undergoing pulmonary balloon valvuloplasty (PBV) at the Cardiovascular Department, Assiut University Hospitals over 3 years. All ages will be included. Exclusion criteria: patients with subvalvular/supravalvular PS, other major congenital heart disease, previous valve intervention, hemodynamic shock, or poor echo windows. A minimum of 60 patients will be recruited. Clinical data, ECG, echo (including speckle tracking), and procedural details will be collected. Patients will be followed at discharge, 1 month, and 6 months to assess RV function and outcomes.

You may qualify if:

• Any age group(no age restriction) Diagnosis of isolated valvular pulmonary stenosis confirmed by echocardiographic evaluation.
• Patients who have undergone or are scheduled to undergo successful pulmonary balloon valvuloplasty (PBV), defined as a post-procedural peak gradient \<40 mmHg with no significant residual obstruction.
• Normal or mildly dysplastic pulmonary valve morphology suitable for balloon valvuloplasty.
• No history of prior cardiac surgery or transcatheter pulmonary valve intervention.

You may not qualify if:

• Presence of other congenital heart diseases (e.g., TOF, VSD, ASD) Previous surgical or catheter-based intervention on the pulmonary valve. Dysplastic pulmonary valve morphology not suitable for PBV Subvalvular or supravalvular pulmonary stenosis. Development of significant procedural complications, such as severe pulmonary regurgitation requiring urgent surgical intervention.
• Patients in hemodynamic shock, with uncontrolled arrhythmias, or other unstable clinical conditions that may interfere with echocardiographic evaluation or follow-up.
• Presence of major systemic illnesses (e.g., advanced hepatic, renal, or pulmonary disease) that could independently affect right heart function or limit follow-up.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (5)

• Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.

  PMID: 25559473 BACKGROUND

• Kan JS, White RI Jr, Mitchell SE, Gardner TJ. Percutaneous balloon valvuloplasty: a new method for treating congenital pulmonary-valve stenosis. N Engl J Med. 1982 Aug 26;307(9):540-2. doi: 10.1056/NEJM198208263070907. No abstract available.

  PMID: 7099226 BACKGROUND

• Baumgartner H, De Backer J, Babu-Narayan SV, Budts W, Chessa M, Diller GP, Lung B, Kluin J, Lang IM, Meijboom F, Moons P, Mulder BJM, Oechslin E, Roos-Hesselink JW, Schwerzmann M, Sondergaard L, Zeppenfeld K; ESC Scientific Document Group. 2020 ESC Guidelines for the management of adult congenital heart disease. Eur Heart J. 2021 Feb 11;42(6):563-645. doi: 10.1093/eurheartj/ehaa554. No abstract available.

  PMID: 32860028 BACKGROUND

• Stout KK, Daniels CJ, Aboulhosn JA, Bozkurt B, Broberg CS, Colman JM, Crumb SR, Dearani JA, Fuller S, Gurvitz M, Khairy P, Landzberg MJ, Saidi A, Valente AM, Van Hare GF. 2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Apr 2;73(12):e81-e192. doi: 10.1016/j.jacc.2018.08.1029. Epub 2018 Aug 16. No abstract available.

  PMID: 30121239 BACKGROUND

• Nasir M, Dejene K, Bedru M, Markos S. Percutaneous balloon pulmonary valvuloplasty in children: a 10-Year retrospective follow-up study in resource-limited settings. BMC Cardiovasc Disord. 2025 May 26;25(1):402. doi: 10.1186/s12872-025-04881-8.

  PMID: 40419953 BACKGROUND

Study Officials

• salma mohamed taha, assistant professor

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 24, 2025
• Study Start: August 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-08

Locations

EG (1)