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. (see Contacts and Locations)
Verified September 2012 by Oslo University Hospital
Sponsor:
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
  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

  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?

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014