Accura Balloon dilatation catheter for Percutaneous Balloon Pulmonary Valvuloplasty among Adult Patients- Its protean use
Not Applicable
- Conditions
- Pulmonary valve Stenosis
- Registration Number
- JPRN-UMIN000051063
- Lead Sponsor
- PS Institute of Cardiology GSVM Kanpur
- Brief Summary
Successful BPV was done in all 43 patients among which 5 patients had dysplastic valve. The mean diameter of the annulus was 18.5 mm. Immediate hemodynamic improvement was observed in 38 patients as peak systolic gradient reduced from 84 to 22 mmHg while 5 patients had <50% reduction of resting gradient though it came down significantly at 6 months. Fluoroscopy and procedural time were 5.2 min and 22.6 min respectively.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
Not provided
Exclusion Criteria
associated infundibular stenosis supravalvular stenosis associated complex cyanotic disease requiring palliation more than Grade III pulmonary leak pulmonary annulus more than 15mm
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Major complications (death, cardiac perforation, tamponade, and bleeding). Minor complications (transient hypotension, ventricular premature contraction, and transient bradycardia)