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

NCT01421030 | Unknown Early Phase 1 DMC

• 1 other identifier: 2011/210
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.Percutaneous pulmonary valve implantation or open heart surgery; what are the patients' and their closest relatives narrative experiences
2. 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. 3.What is the relationship between patient reported outcomes and clinical outcomes before, 1, 3, 6 and 12 months after the treatment?
4. 4.Are there savings in costs related to the individual and their family and society between the two techniques?

Conditions

Congenital Heart Defects

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Quality of life

  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.

  up to 12 month's after treatment

Secondary Outcomes (2)

• Clinical outcomes

  up to 12 months after treatment

• Are there savings in costs related to the individual and their family and society between the two techniques?

  up to 12 months after surgery

Study Arms (1)

quality of life, clinical outcomes and costs

OTHER

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

Interventions

Percutaneous pulmonary valve implantation or open heart surgery PROCEDURE

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

quality of life, clinical outcomes and costs

Eligibility Criteria

• Age: 7 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• aggressive endocarditis
• not circumferential deposit of calcium
• \< 20 kg
• not able to understand, speak or communicate well in Norwegian

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

The Interventional Centre, Rikshospitalet, Oslo University Hospital

Oslo, Sognsvannsvn 20, 0027, Norway

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Erik Fosse, Professor/Head of Department

  The Interventional Centre, Rikshospitalet, Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brith Andresen, Can san

CONTACT

+4723070162; brith.andresen@oslo-universitetssykehus.no

Erik Fosse, Professor/Head of Department

CONTACT

+4723070116; erik.fosse@oslo-universitetssykehus.no

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CNS, MNSc

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: August 22, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2014
• Last Updated: September 25, 2012

Record last verified: 2012-09

Locations

NO (1)