Outcomes in Patients and Their Closest Relatives Treated for Congenital Heart Disease With Catheter Based or Surgical Techniques (MEQC)
This study is currently recruiting participants.
Verified September 2012 by Oslo University Hospital
Sponsor:
Oslo University Hospital
Information provided by (Responsible Party):
Brith Andresen, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01421030
First received: June 24, 2011
Last updated: September 24, 2012
Last verified: September 2012
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Purpose
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?
| Condition | Intervention | Phase |
|---|---|---|
|
Congenital Heart Defects |
Procedure: Percutaneous pulmonary valve implantation or open heart surgery |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Outcomes in Patients and Their Closest Relatives Treated for Congenital Heart Disease With Catheter Based or Surgical Techniques. |
Resource links provided by NLM:
Further study details as provided by Oslo University Hospital:
Primary Outcome Measures:
- Quality of life [ Time Frame: up to 12 month's after treatment ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- Clinical outcomes [ Time Frame: up to 12 months after treatment ] [ Designated as safety issue: Yes ]
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?
- Are there savings in costs related to the individual and their family and society between the two techniques? [ Time Frame: up to 12 months after surgery ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
quality of life, clinical outcomes and costs
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
|
Eligibility| Ages Eligible for Study: | 7 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421030
Contacts
| Contact: Brith Andresen, Can san | +4723070162 | brith.andresen@oslo-universitetssykehus.no |
| Contact: Erik Fosse, Professor/Head of Department | +4723070116 | erik.fosse@oslo-universitetssykehus.no |
Locations
| Norway | |
| The Interventional Centre, Rikshospitalet, Oslo University Hospital | Recruiting |
| Oslo, Sognsvannsvn 20, Norway, 0027 | |
| Contact: Erik Fosse, Professor/Head of Department +4723070116 erik.fosse@oslo-universitetssykehus.no | |
| Principal Investigator: Erik Fosse, Professor | |
Sponsors and Collaborators
Oslo University Hospital
Investigators
| Principal Investigator: | Erik Fosse, Professor/Head of Department | The Interventional Centre, Rikshospitalet, Oslo University Hospital |
More Information
No publications provided
| Responsible Party: | Brith Andresen, CNS, MNSc, Oslo University Hospital |
| ClinicalTrials.gov Identifier: | NCT01421030 History of Changes |
| Other Study ID Numbers: | 2011/210 |
| Study First Received: | June 24, 2011 |
| Last Updated: | September 24, 2012 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics |
Keywords provided by Oslo University Hospital:
|
quality of life congenital heart disease open heart surgery percutaneous pulmonary valve implantation costs |
Additional relevant MeSH terms:
|
Heart Defects, Congenital Heart Diseases Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities |
ClinicalTrials.gov processed this record on May 22, 2013