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

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

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?

Study Overview

• Status: Unknown
• Conditions: Congenital Heart Defects
• Intervention / Treatment: Procedure: Percutaneous pulmonary valve implantation or open heart surgery

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Brith Andresen, Can san; Phone Number: +4723070162; Email: brith.andresen@oslo-universitetssykehus.no
• Study Contact Backup: Name: Erik Fosse, Professor/Head of Department; Phone Number: +4723070116; Email: erik.fosse@oslo-universitetssykehus.no

Study Locations

• Norway
  • Sognsvannsvn 20
    • Oslo, Sognsvannsvn 20, Norway, 0027
      • Recruiting
      • The Interventional Centre, Rikshospitalet, Oslo University Hospital
      • Contact: Erik Fosse, Professor/Head of Department; Phone Number: +4723070116; Email: erik.fosse@oslo-universitetssykehus.no
      • Principal Investigator: Erik Fosse, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcomes	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?	up to 12 months after treatment
Are there savings in costs related to the individual and their family and society between the two techniques?	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.	up to 12 months after surgery

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Erik Fosse, Professor/Head of Department, The Interventional Centre, Rikshospitalet, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ANTICIPATED): September 1, 2012
• Study Completion (ANTICIPATED): September 1, 2014

Study Registration Dates

• First Submitted: June 24, 2011
• First Submitted That Met QC Criteria: August 19, 2011
• First Posted (ESTIMATE): August 22, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 25, 2012
• Last Update Submitted That Met QC Criteria: September 24, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: quality of life; costs; congenital heart disease; open heart surgery; percutaneous pulmonary valve implantation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 2011/210