Outcomes in Patients and Their Closest Relatives Treated for Congenital Heart Disease With Catheter Based or Surgical Techniques

Study Overview
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Brief Summary
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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 Percutaneous pulmonary valve implantation or open heart surgery; what are the patients' and their closest relatives narrative experiences Is there a difference in patient and their closest relatives reported outcomes, measured as health related quality of life, in patients with congenital pulmonary disease before the event, 1, 3, 6 and 12 months after percutaneous intervention versus open heart surgery approach? What is the relationship between patient reported outcomes and clinical outcomes before, 1, 3, 6 and 12 months after the treatment? Are there savings in costs related to the individual and their family and society between the two techniques?

Official Title
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Outcomes in Patients and Their Closest Relatives Treated for Congenital Heart Disease With Catheter Based or Surgical Techniques.

Conditions
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Congenital Heart Defects

Intervention / Treatment
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* Procedure: Percutaneous pulmonary valve implantation or open heart surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: aggressive endocarditis not circumferential deposit of calcium < 20 kg not able to understand, speak or communicate well in Norwegian

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: quality of life, clinical outcomes and costs<br>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<br>* Outcomes before percutaneous pulmonary valve implantation or open heart surgery before, 1, 3, 6 and 12 months after the treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 12 month's after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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? | 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. | up to 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, congenital heart disease, open heart surgery, percutaneous pulmonary valve implantation, costs