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

NCT01421030 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-09-25

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Erik Fosse, Professor/Head of Department · The Interventional Centre, Rikshospitalet, Oslo University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-09-30
Completion
2014-09-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01421030 on ClinicalTrials.gov