Clinical trial NCT01421030: Outcomes in Patients and Their Closest Relatives Treated for Congenital Heart Disease With Catheter Based or Surgical Techniques
Official title: Outcomes in Patients and Their Closest Relatives Treated for Congenital Heart Disease With Catheter Based or Surgical Techniques.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Congenital Heart Defects
Keywords: quality of life
congenital heart disease
open heart surgery
percutaneous pulmonary valve implantation
costs
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-08-22
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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?


Eligibility criteria: 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

Primary outcomes:
measure: Quality of life
timeFrame: up to 12 month's after treatment
Secondary outcomes:
measure: Clinical outcomes
timeFrame: up to 12 months after treatment
measure: Are there savings in costs related to the individual and their family and society between the two techniques?
timeFrame: up to 12 months after surgery
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: The Interventional Centre, Rikshospitalet, Oslo University Hospital
state: Sognsvannsvn 20
Study officials:
affiliation: The Interventional Centre, Rikshospitalet, Oslo University Hospital
name: Erik Fosse, Professor/Head of Department
role: PRINCIPAL_INVESTIGATOR
References: