Congenital Heart DefectsEarly Phase 1MEQCNCT01421030
Outcomes in Patients and Their Closest Relatives Treated for Congenital Heart Disease With Catheter Based or Surgical Techniques
A Early Phase 1 study testing Percutaneous pulmonary valve implantation or open heart surgery in people with Congenital Heart Defects, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 7 to 50 years
- Conditions the study is for
- Congenital Heart Defects
- What is being tested?
- Percutaneous pulmonary valve implantation or open heart surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2011to Sep 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- aggressive endocarditis
- not circumferential deposit of calcium
- < 20 kg
- not able to understand, speak or communicate well in Norwegian
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
The Interventional Centre, Rikshospitalet, Oslo University Hospital
Oslo, Sognsvannsvn 20, 0027
Erik Fosse, Professor/Head of Department, +4723070116, erik.fosse@oslo-universitetssykehus.no
Erik Fosse, Professor
About this study
Official title: 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
- 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?
- Conditions
- Congenital Heart Defects
- Being tested
- Percutaneous pulmonary valve implantation or open heart surgery
- Keywords
- quality of life, congenital heart disease, open heart surgery, percutaneous pulmonary valve implantation, costs
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous pulmonary valve implantation or open heart surgeryProcedure or surgery
Outcomes before percutaneous pulmonary valve implantation or open heart surgery before, 1, 3, 6 and 12 months after the treatment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Percutaneous pulmonary valve implantation or open heart surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 month's after treatment
Secondary outcomes (2)
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?
Measured: 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.
Measured: up to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2012 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DefectsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brith Andresen, Oslo University Hospital
- Investigators
- Erik Fosse, Professor/Head of Department, Principal investigator, The Interventional Centre, Rikshospitalet, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421030
- Sponsor's protocol ID
- 2011/210
- Acronym
- MEQC
- Status last verified
- Sep 2012
- First submitted
- 24 Jun 2011
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes in Patients and Their Closest Relatives Treated for Congenital Heart Disease With Catheter Based or Surgical Techniques.
- ClinicalTrials.gov ID
- NCT01421030
- Acronym / sponsor ID
- MEQC / 2011/210
- Conditions
- Congenital Heart Defects
- Keywords
- quality of life, congenital heart disease, open heart surgery, percutaneous pulmonary valve implantation, costs
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 22 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| quality of life, clinical outcomes and costs | Other | Procedure: Percutaneous pulmonary valve implantation or open heart surgeryQuality of life, clinical outcomes and costs after two different treatment options in patients and closest relatives |
Who may qualify
- Ages
- 7 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- aggressive endocarditis
- not circumferential deposit of calcium
- < 20 kg
- not able to understand, speak or communicate well in Norwegian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous pulmonary valve implantation or open heart surgeryOutcomes before percutaneous pulmonary valve implantation or open heart surgery before, 1, 3, 6 and 12 months after the treatment | Procedure or surgery | quality of life, clinical outcomes and costs |
Primary outcome
Quality of life
Time frame: up to 12 month's after treatment
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.
2 secondary outcomes
Clinical outcomes
Time frame: up to 12 months after treatment
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Fosse, Professor/Head of Department principal investigator
The Interventional Centre, Rikshospitalet, Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Percutaneous pulmonary valve implantation or open heart surgery in people with Congenital Heart Defects, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brith Andresen, Can san (+4723070162, brith.andresen@oslo-universitetssykehus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: up to 12 month's after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2012.