Pulmonary Valve InsufficiencyPhase 3NCT00259207
Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract
A Phase 3 study testing Pulmonary valve insertion and medical surgery hybride in people with Pulmonary Valve Insufficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to compare 2 techniques of pulmonary valve replacement in patients with a large right ventricular outflow tract: a standard surgical treatment using cardiopulmonary bypass versus a medico-surgical hybrid strategy without extracorporeal circulation. Read more about this study
- Who is it for?
- Ages 6 to 90 years
- Conditions the study is for
- Pulmonary Valve Insufficiency
- What is being tested?
- Pulmonary valve insertion and medical surgery hybride
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2005to May 2009
- Phase
- Phase 3
- 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 6 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with surgical indication of pulmonary valve replacement for significant pulmonary regurgitation
- Pulmonary trunk diameter > 22mm
- Age > 5 years old or weight > 20kg
- Acceptance of protocol
- Social regimen security
Who cannot join
- No indication of pulmonary valve replacement
- Age < 5 years old or weight < 20kg
- Extra-cardiac disease with a vital prognosis under 6 months
- Heparin and contrast allergy
- Clinical or biological signs of infection
- Pregnancy
- Patients in emergency state
- Patients included in an another research protocol during the last months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Valve Replacement : Study of Comparison Between a Standard Surgical Approach With Extracorporeal Circulation and an Off-pump Hybrid Strategy.
The purpose of this study is to compare 2 techniques of pulmonary valve replacement in patients with a large right ventricular outflow tract: a standard surgical treatment using cardiopulmonary bypass versus a medico-surgical hybrid strategy without extracorporeal circulation.
Read the detailed description
Pulmonary regurgitation is a common complication late after complete correction of a tetralogy of Fallot. It progressively leads to a right ventricular dilatation that has been strongly associated with ventricular arrhythmia, sudden death and right ventricular insufficiency. Pulmonary valve replacement reduces the rate of complications but the precise timing for this procedure remains unknown. Moreover, pulmonary valve replacement, even before the occurrence of symptoms, doesn't allow for a total recovery in all patients. Reasons are not known, but cardiopulmonary bypass as well as late referral to surgery have been incriminated to explain the persistence of right ventricular dysfunction after surgical valvular. Therefore, a strategy avoiding cardiopulmonary bypass could potentially preserve the right ventricular function and in the meantime reduce the hospitalisation length and morbid-mortality. For the last six years, we and others have developed a technique of percutaneous pulmonary valve implantation. Encouraging results were reported in the treatment of failing right ventricular to pulmonary artery conduit, but presents indications are limited and the innovative technique could not be offered to most of patients requiring pulmonary valve replacement. In particular, to date, conventional surgery is the only approach for patients with large pulmonary trunk over 22 mm in diameter. We had the idea of collaborating with the surgeons to try to improve the outcome of valvular in these patients. We would like to investigate a hybrid strategy in those patients with large right ventricular outflow tract inaccessible to solely transcatheter technique. The studied technique will associate a surgical pulmonary artery banding without cardiopulmonary bypass immediately followed by a transventricular or a transvenous pulmonary valve insertion using a conventional valved stent. The purpose of this randomized study is to evaluate benefits and risks of the medico-surgical hybrid strategy, and to compare both strategies hybrid approach and conventional surgery with extracorporeal circulation in term of right ventricular function recovery.
- Conditions
- Pulmonary Valve Insufficiency
- Being tested
- Pulmonary valve insertion, medical surgery hybride
- Keywords
- Pulmonary valve regurgitation, Valve replacement, Hybrid procedure
- Medical subject headings
- Pulmonary Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary valve insertionProcedure or surgery
Pulmonary valve insertion
medical surgery hybrideProcedure or surgery
medical surgery hybride
| Study group | Role | What they receive |
|---|---|---|
| classic surgery | Active comparator | classic surgery Receives: Procedure: Pulmonary valve insertion |
| medical surgery hybride | Experimental | medical surgery hybride Receives: Procedure: medical surgery hybride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular function
Measured: during the study
Secondary outcomes (2)
Morbidity and mortality
Measured: during the study
Length of stay
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startDec 2005
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Necker-Enfants Malades, European Georges Pompidou Hospital
- Investigators
- Younes BOUDJEMLINE, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259207
- Sponsor's protocol ID
- P040413
- Other IDs
- AOR04068
- Status last verified
- Mar 2007
- First submitted
- 28 Nov 2005
- Last updated
- 30 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boudjemline Y, Schievano S, Bonnet C, Coats L, Agnoletti G, Khambadkone S, Bonnet D, Deanfield J, Sidi D, Bonhoeffer P. Off-pump replacement of the pulmonary valve in large right ventricular outflow tracts: a hybrid approach. J Thorac Cardiovasc Surg. 2005 Apr;129(4):831-7. doi: 10.1016/j.jtcvs.2004.10.027.
PubMed 15821651
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Valve Replacement : Study of Comparison Between a Standard Surgical Approach With Extracorporeal Circulation and an Off-pump Hybrid Strategy.
- ClinicalTrials.gov ID
- NCT00259207
- Acronym / sponsor ID
- P040413
- Conditions
- Pulmonary Valve Insufficiency
- Keywords
- Pulmonary valve regurgitation, Valve replacement, Hybrid procedure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Hôpital Necker-Enfants Malades, European Georges Pompidou Hospital
- Study start
- Dec 2005
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 29 Nov 2005 (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.
The purpose of this study is to compare 2 techniques of pulmonary valve replacement in patients with a large right ventricular outflow tract: a standard surgical treatment using cardiopulmonary bypass versus a medico-surgical hybrid strategy without extracorporeal circulation.
Detailed description
Pulmonary regurgitation is a common complication late after complete correction of a tetralogy of Fallot. It progressively leads to a right ventricular dilatation that has been strongly associated with ventricular arrhythmia, sudden death and right ventricular insufficiency. Pulmonary valve replacement reduces the rate of complications but the precise timing for this procedure remains unknown. Moreover, pulmonary valve replacement, even before the occurrence of symptoms, doesn't allow for a total recovery in all patients. Reasons are not known, but cardiopulmonary bypass as well as late referral to surgery have been incriminated to explain the persistence of right ventricular dysfunction after surgical valvular. Therefore, a strategy avoiding cardiopulmonary bypass could potentially preserve the right ventricular function and in the meantime reduce the hospitalisation length and morbid-mortality. For the last six years, we and others have developed a technique of percutaneous pulmonary valve implantation. Encouraging results were reported in the treatment of failing right ventricular to pulmonary artery conduit, but presents indications are limited and the innovative technique could not be offered to most of patients requiring pulmonary valve replacement. In particular, to date, conventional surgery is the only approach for patients with large pulmonary trunk over 22 mm in diameter. We had the idea of collaborating with the surgeons to try to improve the outcome of valvular in these patients. We would like to investigate a hybrid strategy in those patients with large right ventricular outflow tract inaccessible to solely transcatheter technique. The studied technique will associate a surgical pulmonary artery banding without cardiopulmonary bypass immediately followed by a transventricular or a transvenous pulmonary valve insertion using a conventional valved stent. The purpose of this randomized study is to evaluate benefits and risks of the medico-surgical hybrid strategy, and to compare both strategies hybrid approach and conventional surgery with extracorporeal circulation in term of right ventricular function recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| classic surgery | Active comparator | Procedure: Pulmonary valve insertionclassic surgery |
| medical surgery hybride | Experimental | Procedure: medical surgery hybridemedical surgery hybride |
Who may qualify
- Ages
- 6 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with surgical indication of pulmonary valve replacement for significant pulmonary regurgitation
- Pulmonary trunk diameter > 22mm
- Age > 5 years old or weight > 20kg
- Acceptance of protocol
- Social regimen security
Key exclusion criteria (8 listed)
- No indication of pulmonary valve replacement
- Age < 5 years old or weight < 20kg
- Extra-cardiac disease with a vital prognosis under 6 months
- Heparin and contrast allergy
- Clinical or biological signs of infection
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 |
|---|---|---|
| Pulmonary valve insertionPulmonary valve insertion | Procedure or surgery | classic surgery |
| medical surgery hybridemedical surgery hybride | Procedure or surgery | medical surgery hybride |
Primary outcome
Right ventricular function
Time frame: during the study
2 secondary outcomes
Morbidity and mortality
Time frame: during the study
Length of stay
Time frame: during the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2009.
- Background: PubMed 15821651Boudjemline Y, Schievano S, Bonnet C, Coats L, Agnoletti G, Khambadkone S, Bonnet D, Deanfield J, Sidi D, Bonhoeffer P. Off-pump replacement of the pulmonary valve in large right ventricular outflow tracts: a hybrid approach. J Thorac Cardiovasc Surg. 2005 Apr;129(4):831-7. doi: 10.1016/j.jtcvs.2004.10.027.
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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.
Younes BOUDJEMLINE, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pulmonary valve insertion and medical surgery hybride in people with Pulmonary Valve Insufficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 30 Sep 2009. 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 France. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricular function (time frame: during the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00259207, which also lists 1 linked publication.
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 30 Sep 2009; AzTrials last refreshed its copy on 31 Oct 2026.