An Early Phase 1 interventional study of Percutaneous pulmonary valve implantation or open heart surgery in Congenital Heart Defects, sponsored by Oslo University Hospital. Status unknown at 1 site in Norway. Open to participants aged 7 Years to 50 Years. Per ClinicalTrials.gov, last updated 2012-09-25.
Sponsored by Oslo University Hospital · Early Phase 1, Interventional, and Health services research
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 in children and adolescents affect the whole family, the experience of the patients and their closest relatives are recorded and analysed separately. Cost may be an important factor in the choice of technology (1). Hence, the present study also aims to compare savings in costs, percutaneous versus open technique, related to the individual, their family and society.
1.2 Research questions
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This study's planned enrollment of 40 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
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Exclusion Criteria:
Quality of life, clinical outcomes and costs after two different treatment options in patients and closest relatives
Procedure: Percutaneous pulmonary valve implantation or open heart surgery
Outcomes before percutaneous pulmonary valve implantation or open heart surgery before, 1, 3, 6 and 12 months after the treatment
Quality of life
Percutaneous pulmonary valve implantation or open heart surgery; what are the patients and their closest relatives narrative experiences. Measured before the event, 1, 3, 6, and 12 month's after treatment.
Time frame: up to 12 month's after treatment
Clinical outcomes
What is the relationship between patient reported outcomes and clinical outcomes before, 1, 3, 6 and 12 months after the treatment Is there a difference in the effect of percutaneous versus open surgical technique on operative time, complication rate and reoperations in the peri- and postoperative period?
Time frame: up to 12 months after treatment
Are there savings in costs related to the individual and their family and society between the two techniques?
In order to describe and compare the differences in costs with patients outcomes and quality-adjusted life years, this study aim to calculate both in-hospital care and out-patient clinical costs between percutaneous pulmonary valve implantation and conventional open heart surgery. Measured Before the event, 1, 3, 6 and 12 months after surgery.
Time frame: up to 12 months after surgery
This study is status unknown, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Oslo University Hospital