Dysfunction of the Prosthetic ConductREVALVNCT01250327
Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement (REVALV)
A study testing Melody, bare stent and Surgery in people with Dysfunction of the Prosthetic Conduct and Lesions of the Right Ventricular Outflow Tract, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This prospective interventional study is designed to evaluate the cost/advantage ratio in the treatment of lesions of the right ventricular outflow tract using transcatheter pulmonary valved stent (Melody). Read more about this study
- Who is it for?
- Ages 5 to 70 years
- Conditions the study is for
- Dysfunction of the Prosthetic Conduct, Lesions of the Right Ventricular Outflow Tract
- What is being tested?
- Melody, bare stent and Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Aug 2013
- Phase
- Interventional
- 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 5 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- for the study:
- Lesions of the right ventricular outflow tract in need of surgery for stenosis or regurgitation
- for the Melody arm:
- A 5 to 70 years old patient
- Weight >= 30kg
- RVOT <= to 22mm
- Patient with a dysfunction circumferential prosthetic conduct of diameter >= to 16mm.
Who cannot join
- Vein anatomy incompatibility with a 22Fr delivery health
- Left heart implantation
- RVOT incompatible with a anchoring of the stent (lik in patient operated of a tetralogy of fallot)
- Coronary anomaly with a coronary artery naer the RVOT
- Sever obstruction of the RVOT incompatible with balloon expansion
- Central vein obstruction
Show all 10Show fewer
- Ongoing infection
- Active endocarditis
- Allergy for heparin or aspirin
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement for the Treatment of Lesions of the Ventricular Outflow Tract.
This prospective interventional study is designed to evaluate the cost/advantage ratio in the treatment of lesions of the right ventricular outflow tract using transcatheter pulmonary valved stent (Melody).
Read the detailed description
Rational : transcatheter valve insertion is a new technique enlarging the armamentarium of the treatment of RVOT obstruction and insufficiency. It real place as compared to bare stent implantation and surgery of the RVOT remains unknown.
Main objective : evaluate the cost of the procedure as compared with conventional technique.
Design : multicenter intervention prospective study. Population : 180 patients in three arms (3*60).
End point criteria :
- Primary : cost
- Secondary : rate of reoperation
- Being tested
- Melody, bare stent, Surgery
- Keywords
- right ventricular outflow tract, endovascular valve insertion, economic evaluation, valved stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelodyDevice
Also called insertion of a pulmonic valved stent
insertion of a pulmonic valved stent
bare stentDevice
Also called insertion of a bare metal stent
insertion of a bare metal stent
SurgeryProcedure or surgery
Also called conventional surgery methode
conventional surgery methode
| Study group | Role | What they receive |
|---|---|---|
| Melody | Experimental | insertion of a pulmonic valved stent Receives: Device: Melody |
| Bare stent | Active comparator | insertion of a bare metal stent Receives: Device: bare stent |
| Surgery | Active comparator | conventional surgery methode. Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost induced by the transcatheter pulmonary valve insertion as compared to conventional surgical and insertion of a bare metal stent 24 months after insertion.
Measured: 24 months after intervention
Secondary outcomes (3)
Quality of life
Measured: 24 months after intervention
procedure success rate
Measured: 24 months after intervention
Does the patient need to be operated again?
Measured: 24 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startMar 2009
- Primary completionAug 2013
- Study completionAug 2013
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 Dysfunction of the Prosthetic ConductStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Boudjemline Younes, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250327
- Sponsor's protocol ID
- P080205
- Acronym
- REVALV
- Status last verified
- Oct 2017
- First submitted
- 27 Nov 2010
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Fraisse A, Aldebert P, Malekzadeh-Milani S, Thambo JB, Piechaud JF, Aucoururier P, Chatelier G, Bonnet D, Iserin L, Bonello B, Assaidi A, Kammache I, Boudjemline Y. Melody (R) transcatheter pulmonary valve implantation: results from a French registry. Arch Cardiovasc Dis. 2014 Nov;107(11):607-14. doi: 10.1016/j.acvd.2014.10.001. Epub 2014 Nov 6.
PubMed 25453718
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement for the Treatment of Lesions of the Ventricular Outflow Tract.
- ClinicalTrials.gov ID
- NCT01250327
- Acronym / sponsor ID
- REVALV / P080205
- Keywords
- right ventricular outflow tract, endovascular valve insertion, economic evaluation, valved stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Mar 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 30 Nov 2010 (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 prospective interventional study is designed to evaluate the cost/advantage ratio in the treatment of lesions of the right ventricular outflow tract using transcatheter pulmonary valved stent (Melody).
Detailed description
Rational : transcatheter valve insertion is a new technique enlarging the armamentarium of the treatment of RVOT obstruction and insufficiency. It real place as compared to bare stent implantation and surgery of the RVOT remains unknown.
Main objective : evaluate the cost of the procedure as compared with conventional technique.
Design : multicenter intervention prospective study. Population : 180 patients in three arms (3*60).
End point criteria :
- Primary : cost
- Secondary : rate of reoperation
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Melody | Experimental | Device: Melodyinsertion of a pulmonic valved stent |
| Bare stent | Active comparator | Device: bare stentinsertion of a bare metal stent |
| Surgery | Active comparator | Procedure: Surgeryconventional surgery methode. |
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Lesions of the right ventricular outflow tract in need of surgery for stenosis or regurgitation
- A 5 to 70 years old patient
- Weight >= 30kg
- RVOT <= to 22mm
- Patient with a dysfunction circumferential prosthetic conduct of diameter >= to 16mm.
Key exclusion criteria (10 listed)
- Vein anatomy incompatibility with a 22Fr delivery health
- Left heart implantation
- RVOT incompatible with a anchoring of the stent (lik in patient operated of a tetralogy of fallot)
- Coronary anomaly with a coronary artery naer the RVOT
- Sever obstruction of the RVOT incompatible with balloon expansion
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 |
|---|---|---|
| MelodyAlso: insertion of a pulmonic valved stentinsertion of a pulmonic valved stent | Device | Melody |
| bare stentAlso: insertion of a bare metal stentinsertion of a bare metal stent | Device | Bare stent |
| SurgeryAlso: conventional surgery methodeconventional surgery methode | Procedure or surgery | Surgery |
Primary outcome
Cost induced by the transcatheter pulmonary valve insertion as compared to conventional surgical and insertion of a bare metal stent 24 months after insertion.
Time frame: 24 months after intervention
3 secondary outcomes
Quality of life
Time frame: 24 months after intervention
procedure success rate
Time frame: 24 months after intervention
Does the patient need to be operated again?
Time frame: 24 months after intervention
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 18 Oct 2017.
- Derived from this study: PubMed 25453718Fraisse A, Aldebert P, Malekzadeh-Milani S, Thambo JB, Piechaud JF, Aucoururier P, Chatelier G, Bonnet D, Iserin L, Bonello B, Assaidi A, Kammache I, Boudjemline Y. Melody (R) transcatheter pulmonary valve implantation: results from a French registry. Arch Cardiovasc Dis. 2014 Nov;107(11):607-14. doi: 10.1016/j.acvd.2014.10.001. Epub 2014 Nov 6.
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.
Boudjemline Younes, 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 study testing Melody, bare stent and Surgery in people with Dysfunction of the Prosthetic Conduct and Lesions of the Right Ventricular Outflow Tract, 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 7 inclusion and 10 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 18 Oct 2017. 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.
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?
Cost induced by the transcatheter pulmonary valve insertion as compared to conventional surgical and insertion of a bare metal stent 24 months after insertion. (time frame: 24 months after intervention). 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 NCT01250327, 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 18 Oct 2017.