- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00259207
Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract
September 29, 2009 updated by: Assistance Publique - Hôpitaux de Paris
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France, 75015
- NECKER HOSPITAL for Sick Children, 149 R. de SEVRES
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 90 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: classic surgery
|
Pulmonary valve insertion
|
Experimental: medical surgery hybride
|
medical surgery hybride
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Right ventricular function
Time Frame: during the study
|
during the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Morbidity and mortality
Time Frame: during the study
|
during the study
|
Length of stay
Time Frame: during the study
|
during the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Younes BOUDJEMLINE, MD,PhD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
November 28, 2005
First Submitted That Met QC Criteria
November 28, 2005
First Posted (Estimate)
November 29, 2005
Study Record Updates
Last Update Posted (Estimate)
September 30, 2009
Last Update Submitted That Met QC Criteria
September 29, 2009
Last Verified
March 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P040413
- AOR04068
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pulmonary Valve Insufficiency
-
Charite University, Berlin, GermanyRecruitingPulmonary Regurgitation | Tricuspid RegurgitationGermany
-
Edwards LifesciencesCompletedPulmonary Regurgitation | Pulmonary Insufficiency | Pulmonary StenosisGermany, Ireland, Belgium, Israel, United Kingdom, Italy, Poland, Saudi Arabia, Turkey
-
Taewoong Medical Co., Ltd.Active, not recruitingPulmonary Valve Stenosis | Congenital Heart Defect | Pulmonary Valve; Insufficiency, CongenitalKorea, Republic of
-
Venus MedTech (HangZhou) Inc.IQVIA Inc.; TheraGenesis; IntrialsActive, not recruiting
-
Edwards LifesciencesCompletedPulmonary Valve Insufficiency | Pulmonary Valve Degeneration | Congenital Pulmonary Valve AbnormalityUnited States
-
CryoLife, Inc.CompletedAortic Valve Stenosis | Aortic Valve Insufficiency | Pulmonary Valve Insufficiency | Pulmonary Valve StenosisUnited States
-
Venus MedTech (HangZhou) Inc.Not yet recruitingPulmonary Regurgitation
-
CSD Labs GmbHCompletedAortic Stenosis | Mitral Insufficiency | Tricuspid Regurgitation | Aortic Insufficiency | Mitral Insufficiency and Aortic Stenosis | Insufficiency, Pulmonary | Insufficiency, TricuspidAustria
-
Edwards LifesciencesCompletedPulmonary Valve Insufficiency | Pulmonary Regurgitation | Pulmonary Stenosis | Dysfunctional RVOT Conduit | Pulmonary ObstructionUnited States
-
Edwards LifesciencesRecruitingPulmonary Valve Insufficiency | Complex Congenital Heart Defect | Dysfunctional RVOT Conduit | Pulmonary Valve Degeneration | Pulmonary Valve; ObstructionUnited States
Clinical Trials on Pulmonary valve insertion
-
Medtronic CardiovascularCompletedCongenital Heart Defects | Dysfunctional Right Ventricular Outflow Tract ConduitsUnited States
-
Medtronic CardiovascularCompletedDysfunctional Right Ventricular Outflow Tract (RVOT) ConduitUnited States
-
University of StellenboschUnknown
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University HospitalRecruitingTetralogy of Fallot | Pulmonary RegurgitationDenmark
-
Medical University of ViennaRecruitingCongenital Heart Disease | Pulmonary Valve DisorderAustria
-
Centre Chirurgical Marie LannelongueInstitut für Pharmakologie und Präventive MedizinRecruitingCongenital Heart Disease | Infective Endocarditis | Percutaneous Pulmonary Valve Implantation | Pulmonary Valve; FailureFrance
-
Autus Valve Technologies, Inc.Recruiting
-
Seoul National University HospitalCompletedCardiovascular Abnormalities | Pulmonary Valve Insufficiency | Pulmonary Valve Stenosis | Congenital Heart DefectsKorea, Republic of
-
Medtronic Bakken Research CenterMedtronicCompletedHeart Valve DiseasesCanada, Denmark, Germany, Italy, Netherlands, Spain
-
Venus MedTech (HangZhou) Inc.TheraGenesis GmbH of Oppenheim, Germany; IQVIA MedTech BV of Antwerp, BelgiumNot yet recruitingRight Ventricular Outflow Tract Dysfunction