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

Congenital Heart Defects Clinical Trial

— MEQC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01421030
• Other study ID #: 2011/210
• Status: Recruiting
• Phase: Phase 0
• First received: June 24, 2011
• Last updated: September 24, 2012
• Start date: September 2011
• Est. completion date: September 2014

Study information

• Verified date: September 2012
• Source: Oslo University Hospital
• Contact: Brith Andresen, Can san
• Phone: +4723070162
• Email: brith.andresen[@]oslo-universitetssykehus.no
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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. 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2014
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 50 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Congenital Heart Defects
• Heart Defects, Congenital
• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
Norway	The Interventional Centre, Rikshospitalet, Oslo University Hospital	Oslo	Sognsvannsvn 20

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes