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

NCT ID: NCT01421030

Last Updated: 2012-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-09-30

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

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?

Detailed Description

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Conditions

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Congenital Heart Defects

Keywords

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quality of life congenital heart disease open heart surgery percutaneous pulmonary valve implantation costs

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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quality of life, clinical outcomes and costs

Quality of life, clinical outcomes and costs after two different treatment options in patients and closest relatives

Group Type OTHER

Percutaneous pulmonary valve implantation or open heart surgery

Intervention Type PROCEDURE

Outcomes before percutaneous pulmonary valve implantation or open heart surgery before, 1, 3, 6 and 12 months after the treatment

Interventions

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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

Intervention Type PROCEDURE

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
Minimum Eligible Age

7 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Brith Andresen

CNS, MNSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erik Fosse, Professor/Head of Department

Role: PRINCIPAL_INVESTIGATOR

The Interventional Centre, Rikshospitalet, Oslo University Hospital

Locations

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The Interventional Centre, Rikshospitalet, Oslo University Hospital

Oslo, Sognsvannsvn 20, Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Brith Andresen, Can san

Role: CONTACT

Phone: +4723070162

Email: [email protected]

Erik Fosse, Professor/Head of Department

Role: CONTACT

Phone: +4723070116

Email: [email protected]

Facility Contacts

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Erik Fosse, Professor/Head of Department

Role: primary

Other Identifiers

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2011/210

Identifier Type: -

Identifier Source: org_study_id