Pulmonary valve Stenosis
Conditions
Interventions
Use of Accura Balloon dilatation catheter for Percutaneous Balloon Pulmonary Valvuloplasty among Adult patients
Sponsors
LPS Institute of Cardiology GSVM Kanpur
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: asymptomatic patients with echocardiographic evidence of suitable morphology and maximum instantaneous and mean gradient across the pulmonary valve of more than 60mmHg and 40 mmHg respectively and in symptomatic patients with a maximum instantaneous gradient of more than 50mmHg and mean gradient of more than 30 mmHg.
Exclusion criteria
Exclusion criteria: associated infundibular stenosis supravalvular stenosis associated complex cyanotic disease requiring palliation more than Grade III pulmonary leak pulmonary annulus more than 15mm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful Balloon Pulmonary Valvuloplasty, defined as residual gradient less than 35 mm Hg and absence of any major complication like death, cardiac perforation, tamponade, and bleeding. | — |
Secondary
| Measure | Time frame |
|---|---|
| Major complications (death, cardiac perforation, tamponade, and bleeding). Minor complications (transient hypotension, ventricular premature contraction, and transient bradycardia) | — |
Countries
Asia(except Japan)
Contacts
Public ContactNajeeb Sofi
LPS institute of Cardiology Department of Cardiology
Outcome results
None listed