NCT01421030

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

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 7 Years – 50 Years
• Healthy volunteers: Not accepted

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 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 1. Percutaneous pulmonary valve implantation or open heart surgery; what are the patients' and their closest relatives narrative experiences 2. 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? 3. What is the relationship between patient reported outcomes and clinical outcomes before, 1, 3, 6 and 12 months after the treatment? 4. Are there savings in costs related to the individual and their family and society between the two techniques?

Conditions

• Congenital Heart Defects

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-09-01
• Completion: 2014-09-01
• First posted: 2011-08-22
• Last updated: 2012-09-25

Locations

1 site across 1 country: Norway