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

University of Oslo (UIO)

Status and phase: Unknown; Early Phase 1

Conditions: Congenital Heart Defects

Treatments: Procedure: Percutaneous pulmonary valve implantation or open heart surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01421030

2011/210

Details and patient eligibility

About

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?

Enrollment: 40 estimated patients

Sex: All

Ages: 7 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 1 patient group

quality of life, clinical outcomes and costs

Other group

Description:

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

Treatment:

Procedure: Percutaneous pulmonary valve implantation or open heart surgery