Status:
UNKNOWN
Outcomes in Patients and Their Closest Relatives Treated for Congenital Heart Disease With Catheter Based or Surgical Techniques
Lead Sponsor:
Oslo University Hospital
Conditions:
Congenital Heart Defects
Eligibility:
All Genders
7-50 years
Phase:
EARLY_PHASE1
Brief Summary
This study compares clinical, self- reported and cost outcomes in children and adolescents treated with pulmonary valve implantation, percutaneous versus open surgical technique. Since cardiac surgery...
Eligibility Criteria
Inclusion
- secure indication of pulmonary valve dysfunction (stenosis and, or regurgitation)
- an indication of surgical correction
- body weight according to the recommendation from the producer of the device
- moderate to serious dilatation of right ventricle
- considerable leak in the tricuspidal valve
- information from former surgery; conduit size, gradient of the stenosis measured by EKKO/MR/ catheterization, X-ray.
- be able to speak and communicate well in Norwegian.
Exclusion
- aggressive endocarditis
- not circumferential deposit of calcium
- \< 20 kg
- not able to understand, speak or communicate well in Norwegian
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01421030
Start Date
September 1 2011
End Date
September 1 2014
Last Update
September 25 2012
Active Locations (1)
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1
The Interventional Centre, Rikshospitalet, Oslo University Hospital
Oslo, Sognsvannsvn 20, Norway, 0027