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.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 24, 2011

Last Updated Date

September 24, 2012

Start Date ^ICMJE

September 2011

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01421030 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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 percutanous 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.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 0

Study Design ^ICMJE

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

Condition ^ICMJE

Congenital Heart Defects

Intervention ^ICMJE

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

Study Arm (s)

quality of life, clinical outcomes and costs

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

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2014

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

7 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Brith Andresen, Can san	+4723070162	brith.andresen@oslo-universitetssykehus.no
Contact: Erik Fosse, Professor/Head of Department	+4723070116	erik.fosse@oslo-universitetssykehus.no

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT01421030

Other Study ID Numbers ^ICMJE

2011/210

Has Data Monitoring Committee

Yes

Responsible Party

Brith Andresen, Oslo University Hospital

Study Sponsor ^ICMJE

Oslo University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Erik Fosse, Professor/Head of Department

The Interventional Centre, Rikshospitalet, Oslo University Hospital

Information Provided By

Oslo University Hospital

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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